13 replies to this topic

[Stephanie964]

I forgot to take my dose last night before bed and symptoms hit me just in time for my drive from my kids' daycare to home. Well, my mom's home where we're staying until I find our own place here in Texas (just moved from Oregon two months ago). My mom and I have always had a hard time living under the same roof so I was really nervous moving in to begin with but it's been going great so far.

Until today. I immediately dropped my things just inside the door and went upstairs to get my pill,then had to go back downstairs to get my water to take it. Barely made it to the couch to lay down. My mom was busy making dinner and asked if I was going to make a salad like I had planned on. When I asked how long until the chicken was done she threw a huge fit. When I told her I was dizzy because I forgot my dose last night she came back with the fact that her cousin went for days without it and managed.

Ummm, ok? What do her withdrawals have to do with mine? I'm a different person with different body chemistry with a completely different situation!

Ugh. So I'm stuck with nobody to talk with. I wouldn't feel right burdening my friends with this. Anyone physically hurt from head to toe when you feel heartbroken?

[fishinghat]

Welcome Stephanie

 

Life sure can put in tough spots. All you can do is just the best you can. At least you fixed one problem. You now have 'someone' to talk with. we are always here and have a good set of ears to listen with. The 'everyone is different in withdrawal' idea is really correct. It sure does very a lot.

 

By the way your mom....well sure does sound like the average mom!!   lol   Unless you have been there it is hard to understand what it is like.

[TryinginFL]

Welcome Stephanie!

 

 

Amazing how missing just one dose can cause such horrible reactions!  But you are right, we are all different.

 

Do you have any plans to quit taking this stuff, or do you want someone to answer questions?

 

Please post any time you need to - ask questions, anything!   Remember, we are here for you!

 

Liz 

[Stephanie964]

I take it for Ankylosing Spondylitis, on top of depression. So no plans for changing until my rheumatologist gives me the green light to start biologics. Which will hopefully be this year.

[fishinghat]

check out the biologics carefully before you start as some have very high risks of side effects including shutting down the immune system. Once the dr picks one for you to use let me know what it is and I will do some medical research for you so you can go back and talk imformatively to your dr about any concerns you may have. Hopefully when you get some control on the spondylitis we can then help you get off the Cymnbalta.

 

One step at a time.

[Stephanie964]

Humira is always a first step biologic for AS

[fishinghat]

Gottcha. I will do some digging.

[fishinghat]

This is the drug insert from the Humira manufacturer. Most important info is yellow highlighted and on some of them I have commented. ALL of my comments are in gray.

 

Well I can't load it as the file is too big so I will try to PM it to you. Anyone else interested in a copy please let me know.

 

 

[fishinghat]

Oh Well can't do it that way either!! So we will do it the hard way, copying it.

Key information is bold and in green test and any of my comments are in bold with red test.

DN0735V7 CR22-05126
December 20, 2002
Page 1 of 16
HUMIRAÔ
(adalimumab)
Rx only
Tear at Perforation to Dispense Patient Information
DESCRIPTION
HUMIRA (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for
human tumor necrosis factor (TNF). HUMIRA was created using phage display
technology resulting in an antibody with human derived heavy and light chain variable
regions and human IgG1:k constant regions. HUMIRA is produced by recombinant DNA
technology in a mammalian cell expression system and is purified by a process that
includes specific viral inactivation and removal steps. It consists of 1330 amino acids and
has a molecular weight of approximately 148 kilodaltons.

(The use of viruses to do gene therapy in humans which produces a protein that fights RA)

HUMIRA is supplied in single-use, 1 mL pre-filled glass syringes, and also 2 mL glass
vials as a sterile, preservative-free solution for subcutaneous administration. The solution
of HUMIRA is clear and colorless, with a pH of about 5.2. Each syringe delivers 0.8 mL
(40 mg) of drug product. Each vial contains approximately 0.9 mL of solution to deliver
0.8 mL (40 mg) of drug product. Each 0.8 mL HUMIRA contains 40 mg adalimumab,
4.93 mg sodium chloride, 0.69 mg monobasic sodium phosphate dihydrate, 1.22 mg
dibasic sodium phosphate dihydrate, 0.24 mg sodium citrate, 1.04 mg citric acid
monohydrate, 9.6 mg mannitol, 0.8 mg polysorbate 80 and Water for Injection, USP.
Sodium hydroxide added as necessary to adjust pH.
CLINICAL PHARMACOLOGY
General
WARNING
RISK OF INFECTIONS
Cases of tuberculosis (frequently disseminated or extrapulmonary at clinical
presentation) have been observed in patients receiving HUMIRA.
Patients should be evaluated for latent tuberculosis infection with a tuberculin
skin test. Treatment of latent tuberculosis infection should be initiated prior to
therapy with HUMIRA.
DN0735V7 CR22-05126
December 20, 2002
Page 2 of 16
Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and
p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in
vitro in the presence of complement. Adalimumab does not bind or inactivate
lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine that is involved in
normal inflammatory and immune responses. Elevated levels of TNF are found in the
synovial fluid of rheumatoid arthritis patients and play an important role in both the
pathologic inflammation and the joint destruction that are hallmarks of rheumatoid
arthritis.
Adalimumab also modulates biological responses that are induced or regulated by TNF,
including changes in the levels of adhesion molecules responsible for leukocyte
migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10M).
Pharmacodynamics
After treatment with HUMIRA, a rapid decrease in levels of acute phase reactants of
inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and
serum cytokines (IL-6) was observed compared to baseline in patients with rheumatoid
arthritis. Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce
tissue remodeling responsible for cartilage destruction were also decreased after
HUMIRA administration.
Pharmacokinetics
The maximum serum concentration (Cmax) and the time to reach the maximum
concentration (Tmax) were 4.7 ± 1.6 mg/mL and 131 ± 56 hours respectively, following a
single 40 mg subcutaneous administration of HUMIRA to healthy adult subjects. The
average absolute bioavailability of adalimumab estimated from three studies following a
single 40 mg subcutaneous dose was 64%. The pharmacokinetics of adalimumab were
linear over the dose range of 0.5 to 10.0 mg/kg following a single intravenous dose.
The single dose pharmacokinetics of adalimumab were determined in several studies with
intravenous doses ranging from 0.25 to 10 mg/kg. The distribution volume (Vss) ranged
from 4.7 to 6.0 L. The systemic clearance of adalimumab is approximately 12 mL/hr. The
mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across
studies. Adalimumab concentrations in the synovial fluid from five rheumatoid arthritis
patients ranged from 31- 96% of those in serum.
Adalimumab mean steady-state trough concentrations of approximately 5 mg/mL and 8 to
9 mg/mL, were observed without and with methotrexate (MTX) respectively. The serum
adalimumab trough levels at steady state increased approximately proportionally with
dose following 20, 40 and 80 mg every other week and every week subcutaneous dosing.
In long-term studies with dosing more than two years, there was no evidence of changes
in clearance over time.
DN0735V7 CR22-05126
December 20, 2002
Page 3 of 16
Population pharmacokinetic analyses revealed that there was a trend toward higher
apparent clearance of adalimumab in the presence of anti-adalimumab antibodies, and
lower clearance with increasing age in patients aged 40 to >75 years.

(Those over 40 Humira is excreted faster and is therefore less effective)

Minor increases in apparent clearance were also predicted in patients receiving doses
lower than the recommended dose and in patients with high rheumatoid factor or CRP
concentrations. These increases are not likely to be clinically important.
No gender-related pharmacokinetic differences were observed after correction for a
patient’s body weight. Healthy volunteers and patients with rheumatoid arthritis
displayed similar adalimumab pharmacokinetics.
No pharmacokinetic data are available in patients with hepatic or renal impairment.
HUMIRA has not been studied in children.
Drug Interactions
MTX reduced adalimumab apparent clearance after single and multiple dosing by 29%
and 44% respectively.
CLINICAL STUDIES
The efficacy and safety of HUMIRA were assessed in four randomized, double-blind
studies in patients ³ age 18 with active rheumatoid arthritis diagnosed according to
American College of Rheumatology (ACR) criteria. Patients had at least 6 swollen and 9
tender joints. HUMIRA was administered subcutaneously in combination with MTX
(12.5 to 25 mg, Studies I and III) or as monotherapy (Study II) or with other diseasemodifying
anti-rheumatic drugs (DMARDs) (Study IV).
Study I evaluated 271 patients who had failed therapy with at least one but no more than
four DMARDs and had inadequate response to MTX. Doses of 20, 40 or 80 mg of
HUMIRA or placebo were given every other week for 24 weeks.
Study II evaluated 544 patients who had failed therapy with at least one DMARD. Doses
of placebo, 20 or 40 mg of HUMIRA were given as monotherapy every other week or
weekly for 26 weeks.
Study III evaluated 619 patients who had an inadequate response to MTX. Patients
received placebo, 40 mg of HUMIRA every other week with placebo injections on
alternate weeks, or 20 mg of HUMIRA weekly for up to 52 weeks. Study III had an
additional primary endpoint at 52 weeks of inhibition of disease progression (as detected
by X-ray results).
Study IV assessed safety in 636 patients who were either DMARD-naive or were
permitted to remain on their pre-existing rheumatologic therapy provided that therapy
was stable for a minimum of 28 days. Patients were randomized to 40 mg of HUMIRA
or placebo every other week for 24 weeks.
DN0735V7 CR22-05126
December 20, 2002
Page 4 of 16
The percent of HUMIRA treated patients achieving ACR 20, 50 and 70 responses in
Studies II and III are shown in Table 1.
Table 1 : ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Study II
Monotherapy
(26 weeks)
Study III
Methotrexate Combination
(24 and 52 weeks)
Response Placebo
N=110
HUMIRA
40 mg
every other
week
N=113
HUMIRA
40 mg
weekly
N=103
Placebo/MTX
N=200
HUMIRA/MTX
40 mg
every other week
N=207
ACR20
Month 6 19% 46%* 53%* 30% 63%*
Month 12 NA NA NA 24% 59%*
ACR50
Month 6 8% 22%* 35%* 10% 39%*
Month 12 NA NA NA 10% 42%*
ACR70
Month 6 2% 12%* 18%* 3% 21%*
Month 12 NA NA NA 5% 23%*
* p<0.01, HUMIRA vs. placebo
The results of Study I were similar to Study III; patients receiving HUMIRA 40 mg every
other week in Study I also achieved ACR 20, 50 and 70 response rates of 65%, 52% and
24%, respectively, compared to placebo responses of 13%, 7% and 3% respectively, at 6
months (p<0.01).
The results of the components of the ACR response criteria for Studies II and III are
shown in Table 2. Improvement was seen in all components and was maintained to week
52.
DN0735V7 CR22-05126
December 20, 2002
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Table 2: Components of ACR Response in Studies II and III
Study II Study III
Placebo
N=110
HUMIRAa
N=113
Placebo/MTX
N=200
HUMIRAa/MTX
N=207
Parameter (median)
Baseline Wk 26 Baseline Wk 26 Baseline Wk 24 Baseline Wk 24
Number of tender joints (0-68) 35 26 31 16* 26 15 24 8*
Number of swollen joints (0-66) 19 16 18 10* 17 11 18 5*
Physician global assessmentb 7.0 6.1 6.6 3.7* 6.3 3.5 6.5 2.0*
Patient global assessmentb 7.5 6.3 7.5 4.5* 5.4 3.9 5.2 2.0*
Painb 7.3 6.1 7.3 4.1* 6.0 3.8 5.8 2.1*
Disability index (HAQ)c 2.0 1.9 1.9 1.5* 1.5 1.3 1.5 0.8*
CRP (mg/dL) 3.9 4.3 4.6 1.8* 1.0 0.9 1.0 0.4*
a 40 mg HUMIRA administered every other week
b Visual analogue scale; 0 = best, 10 = worst
c Disability Index of the Health Assessment Questionnaire2; 0 = best, 3 = worst, measures the patient’s ability to
perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity
* p<0.001, HUMIRA vs. placebo, based on mean change from baseline
The time course of ACR 20 response for Study III is shown in Figure 1.
In Study III, 85% of patients with ACR 20 responses at week 24 maintained the response
at 52 weeks. The time course of ACR 20 response for Study I and Study II were similar.
In Study IV, 53% of patients treated with HUMIRA 40 mg every other week plus
standard of care had an ACR 20 response at week 24 compared to 35% on placebo plus
standard of care (p<0.001). No unique adverse reactions related to the combination of
HUMIRA and other DMARDs were observed.
Figure 1: Study III ACR 20 Responses over 52 Weeks
0
10
20
30
40
50
60
70
0 8 16 24 32 40 48
Time (Weeks)
Percent ACR20 Responders
40 mg every other week Placebo
DN0735V7 CR22-05126
December 20, 2002
Page 6 of 16
In all four studies, HUMIRA showed significantly greater improvement than placebo in
the disability index of Health Assessment Questionnaire (HAQ) from baseline to the end
of study, and significantly greater improvement than placebo in the health-outcomes as
assessed by The Short Form Health Survey (SF 36). Improvement was seen in both the
Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Radiographic Response
In Study III, structural joint damage was assessed radiographically and expressed as
change in Total Sharp Score (TSS) and its components, the erosion score and Joint Space
Narrowing (JSN) score, at month 12 compared to baseline. At baseline, the median TSS
was approximately 55 in the placebo and 40 mg every other week groups. The results are
shown in Table 3. HUMIRA/MTX treated patients demonstrated less radiographic
progression than patients receiving MTX alone.
Table 3: Radiographic Mean Changes Over 12 Months in Study III
Placebo/MTX HUMIRA/MTX
40 mg every
other week
Placebo/MTXHUMIRA/
MTX
(95% Confidence
Interval*)
P-value**
Total Sharp score 2.7 0.1 2.6 (1.4, 3.8) <0.001
Erosion score 1.6 0.0 1.6 (0.9, 2.2) <0.001
JSN score 1.0 0.1 0.9 (0.3, 1.4) 0.002
*95% confidence intervals for the differences in change scores between MTX and
HUMIRA.
**Based on rank analysis
INDICATIONS AND USAGE
HUMIRA is indicated for reducing signs and symptoms and inhibiting the progression of
structural damage in adult patients with moderately to severely active rheumatoid arthritis
who have had an inadequate response to one or more DMARDs. HUMIRA can be used
alone or in combination with MTX or other DMARDs.
CONTRAINDICATIONS
HUMIRA should not be administered to patients with known hypersensitivity to
HUMIRA or any of its components.
DN0735V7 CR22-05126
December 20, 2002
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WARNINGS
SERIOUS INFECTIONS AND SEPSIS, INCLUDING FATALITIES, HAVE BEEN
REPORTED WITH THE USE OF TNF BLOCKING AGENTS INCLUDING
HUMIRA. MANY OF THE SERIOUS INFECTIONS HAVE OCCURRED IN
PATIENTS ON CONCOMITANT IMMUNOSUPPRESSIVE THERAPY THAT,
IN ADDITION TO THEIR RHEUMATOID ARTHRITIS, COULD PREDISPOSE
THEM TO INFECTIONS. TUBERCULOSIS AND INVASIVE OPPORTUNISTIC
FUNGAL INFECTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED
WITH TNF BLOCKING AGENTS INCLUDING HUMIRA.
TREATMENT WITH HUMIRA SHOULD NOT BE INITIATED IN PATIENTS
WITH ACTIVE INFECTIONS INCLUDING CHRONIC OR LOCALIZED
INFECTIONS. PATIENTS WHO DEVELOP A NEW INFECTION WHILE
UNDERGOING TREATMENT WITH HUMIRA SHOULD BE MONITORED
CLOSELY. ADMINISTRATION OF HUMIRA SHOULD BE DISCONTINUED
IF A PATIENT DEVELOPS A SERIOUS INFECTION. PHYSICIANS SHOULD
EXERCISE CAUTION WHEN CONSIDERING THE USE OF HUMIRA IN
PATIENTS WITH A HISTORY OF RECURRENT INFECTION OR
UNDERLYING CONDITIONS WHICH MAY PREDISPOSE THEM TO
INFECTIONS, OR PATIENTS WHO HAVE RESIDED IN REGIONS WHERE
TUBERCULOSIS AND HISTOPLASMOSIS ARE ENDEMIC (see
PRECAUTIONS - Tuberculosis and ADVERSE REACTIONS - Infections). THE
BENEFITS AND RISKS OF HUMIRA TREATMENT SHOULD BE
CAREFULLY CONSIDERED BEFORE INITIATION OF HUMIRA THERAPY.

(The greatest risk is the increased risk of infections)

Neurologic Events
Use of TNF blocking agents, including HUMIRA, has been associated with rare cases of
exacerbation of clinical symptoms and/or radiographic evidence of demyelinating
disease. Prescribers should exercise caution in considering the use of HUMIRA in
patients with preexisting or recent-onset central nervous system demyelinating disorders.
Malignancies
Lymphomas have been observed in patients treated with TNF blocking agents including
HUMIRA. In clinical trials, patients treated with HUMIRA had a higher incidence of
lymphoma than the expected rate in the general population (see ADVERSE

Lymphoma is any of a group of blood cell tumors that develop from lymphatic cells. The name often refers to just the cancerous ones rather than all such tumors.[1] Signs and symptoms may include enlarged lymph nodes, fever, drenching sweats, unintended weight loss, itching, and feeling tired.[2][3] The enlarged lymph nodes are usually painless.[2] The sweats are most common at night.[2][3] Wiki

REACTIONS-Malignancies). While patients with rheumatoid arthritis, particularly
those with highly active disease, may be at a higher risk (up to several fold) for the
development of lymphoma, the role of TNF blockers in the development of malignancy is
not known4,5.
PRECAUTIONS
DN0735V7 CR22-05126
December 20, 2002
Page 8 of 16
General
Allergic reactions have been observed in approximately 1% of patients receiving
HUMIRA. If an anaphylactic reaction or other serious allergic reaction occurs,
administration of HUMIRA should be discontinued immediately and appropriate therapy
initiated.
Information to Patients
The first injection should be performed under the supervision of a qualified health care
professional. If a patient or caregiver is to administer HUMIRA, he/she should be
instructed in injection techniques and their ability to inject subcutaneously should be
assessed to ensure the proper administration of HUMIRA (see HUMIRA, PATIENT
INFORMATION LEAFLET). A puncture-resistant container for disposal of needles
and syringes should be used. Patients or caregivers should be instructed in the technique
as well as proper syringe and needle disposal, and be cautioned against reuse of these
items.
Tuberculosis
As observed with other TNF blocking agents, tuberculosis associated with the
administration of HUMIRA in clinical trials has been reported (see WARNINGS). While
cases were observed at all doses, the incidence of tuberculosis reactivations was
particularly increased at doses of HUMIRA that were higher than the recommended dose.
All patients recovered after standard antimicrobial therapy. No deaths due to tuberculosis
occurred during the clinical trials.
Before initiation of therapy with HUMIRA, patients should be evaluated for active or
latent tuberculosis infection with a tuberculin skin test. If latent infection is diagnosed,
appropriate prophylaxis in accordance with the Centers for Disease Control and
Prevention guidelines6 should be instituted. Patients should be instructed to seek medical
advice if signs/symptoms (e.g., persistent cough, wasting/weight loss, low grade fever)
suggestive of a tuberculosis infection occur.
Immunosuppression
The possibility exists for TNF blocking agents, including HUMIRA, to affect host
defenses against infections and malignancies since TNF mediates inflammation and
modulates cellular immune responses. In a study of 64 patients with rheumatoid arthritis
treated with HUMIRA, there was no evidence of depression of delayed-type
hypersensitivity, depression of immunoglobulin levels, or change in enumeration of
effector T- and B-cells and NK-cells, monocyte/macrophages, and neutrophils. The
impact of treatment with HUMIRA on the development and course of malignancies, as
well as active and/or chronic infections is not fully understood (see WARNINGS,
ADVERSE REACTIONS, Infections and Malignancies). The safety and efficacy of
HUMIRA in patients with immunosuppression have not been evaluated.
DN0735V7 CR22-05126
December 20, 2002
Page 9 of 16
Immunizations
No data are available on the effects of vaccination in patients receiving HUMIRA. Live
vaccines should not be given concurrently with HUMIRA. No data are available on the
secondary transmission of infection by live vaccines in patients receiving HUMIRA.
Autoimmunity
Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in
the development of a lupus-like syndrome. If a patient develops symptoms suggestive of
a lupus-like syndrome following treatment with HUMIRA, treatment should be
discontinued (see ADVERSE REACTIONS, Autoantibodies).
Drug Interactions
HUMIRA has been studied in rheumatoid arthritis patients taking concomitant MTX (see
CLINICAL PHARMACOLOGY: Drug Interactions). The data do not suggest the
need for dose adjustment of either HUMIRA or MTX.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies of HUMIRA have not been conducted to evaluate the
carcinogenic potential or its effect on fertility. No clastogenic or mutagenic effects of
HUMIRA were observed in the in vivo mouse micronucleus test or the Salmonella-
Escherichia coli (Ames) assay, respectively.
Pregnancy
Pregnancy Category B - An embryo-fetal perinatal developmental toxicity study has
been performed in cynomolgus monkeys at dosages up to 100 mg/kg (266 times human
AUC when given 40 mg subcutaneous with MTX every week or 373 times human AUC
when given 40 mg subcutaneous without MTX) and has revealed no evidence of harm to
the fetuses due to adalimumab. There are, however, no adequate and well-controlled
studies in pregnant women. Because animal reproduction and developmental studies are
not always predictive of human response, HUMIRA should be used during pregnancy
only if clearly needed.
Nursing Mothers
It is not known whether adalimumab is excreted in human milk or absorbed systemically
after ingestion. Because many drugs and immunoglobulins are excreted in human milk,
and because of the potential for serious adverse reactions in nursing infants from
HUMIRA, a decision should be made whether to discontinue nursing or to discontinue
the drug, taking into account the importance of the drug to the mother.
DN0735V7 CR22-05126
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Page 10 of 16
Pediatric Use
Safety and effectiveness of HUMIRA in pediatric patients have not been established.
Geriatric Use
A total of 519 patients 65 years of age and older, including 107 patients 75 years and
older, received HUMIRA in clinical studies. No overall difference in effectiveness was
observed between these subjects and younger subjects. The frequency of serious infection
and malignancy among HUMIRA treated subjects over age 65 was higher than for those
under age 65. Because there is a higher incidence of infections and malignancies in the
elderly population in general, caution should be used when treating the elderly.
ADVERSE REACTIONS
General
The most serious adverse reactions were (see WARNINGS):
· Serious Infections
· Neurologic Events
· Malignancies
The most common adverse reaction with HUMIRA was injection site reactions. In
placebo-controlled trials, 20% of patients treated with HUMIRA developed injection site
reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of
patients receiving placebo. Most injection site reactions were described as mild and
generally did not necessitate drug discontinuation.
The proportion of patients who discontinued treatment due to adverse events during the
double-blind, placebo-controlled portion of Studies I, II, III and IV was 7% for patients
taking HUMIRA and 4% for placebo-treated patients. The most common adverse events
leading to discontinuation of HUMIRA were clinical flare reaction (0.7%), rash (0.3%)
and pneumonia (0.3%).
Because clinical trials are conducted under widely varying and controlled conditions,
adverse reaction rates observed in clinical trials of a drug cannot be directly compared to
rates in the clinical trials of another drug and may not predict the rates observed in a
broader patient population in clinical practice.
Infections
In placebo-controlled trials, the rate of infection was 1 per patient year in the HUMIRA
treated patients and 0.9 per patient year in the placebo-treated patients. The infections
consisted primarily of upper respiratory tract infections, bronchitis and urinary tract
infections. Most patients continued on HUMIRA after the infection resolved. The
incidence of serious infections was 0.04 per patient year in HUMIRA treated patients and
0.02 per patient year in placebo-treated patients. Serious infections observed included
DN0735V7 CR22-05126
December 20, 2002
Page 11 of 16
pneumonia, septic arthritis, prosthetic and post-surgical infections, erysipelas, cellulitis,
diverticulitis, and pyelonephritis (see WARNINGS).
Thirteen cases of tuberculosis, including miliary, lymphatic, peritoneal, and pulmonary
were reported in clinical trials. Most of the cases of tuberculosis occurred within the first
eight months after initiation of therapy and may reflect recrudescence of latent disease.
Six cases of invasive opportunistic infections caused by histoplasma, aspergillus, and
nocardia were also reported in clinical trials (see WARNINGS).
Malignancies
Among 2468 rheumatoid arthritis patients treated in clinical trials with HUMIRA for a
median of 24 months, 48 malignancies of various types were observed, including 10
patients with lymphoma. The Standardized Incidence Ratio (SIR) (ratio of observed rate
to age-adjusted expected frequency in the general population) for malignancies was 1.0
(95% CI, 0.7, 1.3) and for lymphomas was 5.4 (95% CI, 2.6, 10.0). An increase of up to
several fold in the rate of lymphomas has been reported in the rheumatoid arthritis patient
population4, and may be further increased in patients with more severe disease activity5
(see WARNINGS-Malignancies). The other malignancies observed during use of
HUMIRA were breast, colon-rectum, uterine-cervical, prostate, melanoma, gallbladderbile
ducts, and other carcinomas.
Autoantibodies
In the controlled trials, 12% of patients treated with HUMIRA and 7% of placebo-treated
patients that had negative baseline ANA titers developed positive titers at week 24. One
patient out of 2334 treated with HUMIRA developed clinical signs suggestive of newonset
lupus-like syndrome. The patient improved following discontinuation of therapy.
No patients developed lupus nephritis or central nervous system symptoms. The impact
of long-term treatment with HUMIRA on the development of autoimmune diseases is
unknown.
Immunogenicity
Patients in Studies I, II, and III were tested at multiple time points for antibodies to
adalimumab during the 6 to 12 month period. Approximately 5% (58 of 1,062) of adult
rheumatoid arthritis patients receiving HUMIRA developed low-titer antibodies to
adalimumab at least once during treatment, which were neutralizing in vitro. Patients
treated with concomitant MTX had a lower rate of antibody development than patients on
HUMIRA monotherapy (1% versus 12%). No apparent correlation of antibody
development to adverse events was observed. With monotherapy, patients receiving
every other week dosing may develop antibodies more frequently than those receiving
weekly dosing. In patients receiving the recommended dosage of 40 mg every other
week as monotherapy, the ACR 20 response was lower among antibody-positive patients
than among antibody-negative patients. The long-term immunogenicity of HUMIRA is
unknown.
DN0735V7 CR22-05126
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Page 12 of 16
The data reflect the percentage of patients whose test results were considered positive for
antibodies to adalimumab in an ELISA assay, and are highly dependent on the sensitivity
and specificity of the assay. Additionally the observed incidence of antibody positivity in
an assay may be influenced by several factors including sample handling, timing of
sample collection, concomitant medications, and underlying disease. For these reasons,
comparison of the incidence of antibodies to adalimumab with the incidence of antibodies
to other products may be misleading.
Other Adverse Reactions
The data described below reflect exposure to HUMIRA in 2334 patients, including 2073
exposed for 6 months, 1497 exposed for greater than one year and 1380 in adequate and
well-controlled studies (Studies I, II, III, and IV). HUMIRA was studied primarily in
placebo-controlled trials and in long-term follow up studies for up to 36 months duration.
The population had a mean age of 54 years, 77% were female, 91% were Caucasian and
had moderately to severely active rheumatoid arthritis. Most patients received 40 mg
HUMIRA every other week.
Table 4 summarizes events reported at a rate of at least 5% in patients treated with
HUMIRA 40 mg every other week compared to placebo and with an incidence higher
than placebo. Adverse event rates in patients treated with HUMIRA 40 mg weekly were
similar to rates in patients treated with HUMIRA 40 mg every other week.
Table 4: Adverse Events Reported by ³5% of Patients Treated with HUMIRA During Placebo-
Controlled Period of Rheumatoid Arthritis Studies
HUMIRA Placebo
40 mg subcutaneous
Every Other Week
(N=705) (N=690)
Adverse Event (Preferred Term) Percentage Percentage
Respiratory
Upper respiratory infection 17 13
Sinusitis 11 9
Flu syndrome 7 6
Gastrointestinal
Nausea 9 8
Abdominal pain 7 4
Laboratory Tests*
Laboratory test abnormal 8 7
Hypercholesterolemia 6 4
Hyperlipidemia 7 5
Hematuria 5 4
Alkaline phosphatase increased 5 3
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Page 13 of 16
Other
Injection site pain 12 12
Headache 12 8
Rash 12 6
Accidental injury 10 8
Injection site reaction** 8 1
Back pain 6 4
Urinary tract infection 8 5
Hypertension 5 3
* Laboratory test abnormalities were reported as adverse events in European trials
** Does not include erythema and/or itching, hemorrhage, pain or swelling

(after each adverse event listed above there is 2 numbers. Eg, Rash 12 6 This would indicate 12% of  people developed rashes that were Humera treated and 6% that were only given a placebo injection.)

Other Adverse Events
Other infrequent serious adverse events occurring at an incidence of less than 5% in
patients treated with HUMIRA were:
Body As A Whole: Fever, infection, pain in extremity, pelvic pain, sepsis, surgery,
thorax pain, tuberculosis reactivated
Cardiovascular System: Arrhythmia, atrial fibrillation, cardiovascular disorder, chest
pain, congestive heart failure, coronary artery disorder, heart arrest, hypertensive
encephalopathy, myocardial infarct, palpitation, pericardial effusion, pericarditis,
syncope, tachycardia, vascular disorder
Collagen Disorder: Lupus erythematosus syndrome
Digestive System: Cholecystitis, cholelithiasis, esophagitis, gastroenteritis,
gastrointestinal disorder, gastrointestinal hemorrhage, hepatic necrosis, vomiting
Endocrine System: Parathyroid disorder
Hemic And Lymphatic System: Agranulocytosis, granulocytopenia, leukopenia,
lymphoma like reaction, pancytopenia, polycythemia
Metabolic And Nutritional Disorders: Dehydration, healing abnormal, ketosis,
paraproteinemia, peripheral edema
Musculo—Skeletal System: Arthritis, bone disorder, bone fracture (not spontaneous),
bone necrosis, joint disorder, muscle cramps, myasthenia, pyogenic arthritis, synovitis,
tendon disorder
Neoplasia: Adenoma, carcinomas such as breast, gastrointestinal, skin, urogenital, and
others; lymphoma and melanoma.
DN0735V7 CR22-05126
December 20, 2002
Page 14 of 16
Nervous System: Confusion, multiple sclerosis, paresthesia, subdural hematoma, tremor
Respiratory System: Asthma, bronchospasm, dyspnea, lung disorder, lung function
decreased, pleural effusion, pneumonia
Skin And Appendages: Cellulitis, erysipelas, herpes zoster
Special Senses: Cataract
Thrombosis: Thrombosis leg
Urogenital System: Cystitis, kidney calculus, menstrual disorder, pyelonephritis

(While these have rare occurances it is a long list of some very signicant conitiond that can develop)

OVERDOSAGE
The maximum tolerated dose of HUMIRA has not been established in humans. Multiple
doses up to 10 mg/kg have been administered to patients in clinical trials without
evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the
patient be monitored for any signs or symptoms of adverse reactions or effects and
appropriate symptomatic treatment instituted immediately.
DOSAGE AND ADMINISTRATION
The recommended dose of HUMIRA for adult patients with rheumatoid arthritis is 40 mg
administered every other week as a subcutaneous injection. MTX, glucocorticoids,
salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics or other
DMARDs may be continued during treatment with HUMIRA. Some patients not taking
concomitant MTX may derive additional benefit from increasing the dosing frequency of
HUMIRA to 40 mg every week.
HUMIRA is intended for use under the guidance and supervision of a physician. Patients
may self-inject HUMIRA if their physician determines that it is appropriate and with
medical follow-up, as necessary, after proper training in injection technique.
The solution in the syringe and in the vial should be carefully inspected visually for
particulate matter and discoloration prior to subcutaneous administration. If particulates
and discolorations are noted, the product should not be used. HUMIRA does not contain
preservatives; therefore, unused portions of drug remaining from the syringe or vial
should be discarded. NOTE: The needle cover of the syringe contains dry rubber (latex),
which should not be handled by persons sensitive to this substance.
Patients using the pre-filled syringes should be instructed to inject the full amount in the
syringe (0.8 mL), which provides 40 mg of HUMIRA. For patients and institutions using
vials, 0.8 mL of solution providing 40 mg of HUMIRA should be withdrawn from the
DN0735V7 CR22-05126
December 20, 2002
Page 15 of 16
vial and administered according to the directions provided in the Patient Information
Leaflet.
Injection sites should be rotated and injections should never be given into areas where the
skin is tender, bruised, red or hard (see PATIENT INFORMATION LEAFLET).
Instructions For Activating the Needle Stick Device: Cartons for institutional use
contain a syringe and needle with a needle protection device (see HOW SUPPLIED). To
activate the needle stick protection device after injection, hold the syringe in one hand
and, with the other hand, slide the outer protective shield over the exposed needle until it
locks into place.
Storage and Stability
Do not use beyond the expiration date on the container. HUMIRA must be refrigerated at
2-8° C (36-46° F). DO NOT FREEZE. Protect the vial or/and pre-filled syringe from
exposure to light. Store in original carton until time of administration.
HOW SUPPLIED
HUMIRAÔ (adalimumab) is supplied in glass vials and syringes as a preservative-free,
sterile solution for subcutaneous administration. The following packaging configurations
are available:
Patient Use Syringe Carton
HUMIRA is dispensed in a carton containing two alcohol preps and two dose trays. Each
dose tray consists of a single-use, 1 mL pre-filled glass syringe with a fixed 27 gauge ½
inch needle, providing 40 mg (0.8 mL) of HUMIRA. The NDC number is 0074-3799-
02.
Patient Use Vial Carton
HUMIRA is dispensed in a carton containing four alcohol preps and two trays. Each dose
tray consists of a single-use, 2 mL glass vial providing 40 mg (0.8 mL) of HUMIRA and
one sterile 1 mL syringe with a fixed 25 gauge ? inch needle. The NDC number is
0074-3797-02.
Institutional Use Syringe Carton
Each carton contains two alcohol preps and one tray. Each dose tray consists of a single
use, 1 mL pre-filled glass syringe with a fixed 27 gauge ½ inch needle (with a needle
stick protection device) providing 40 mg (0.8 mL) HUMIRA. The NDC number is
0074-3799-01.
Institutional Use Vial Carton
DN0735V7 CR22-05126
December 20, 2002
Page 16 of 16
Each carton contains two alcohol preps and one tray. Each dose tray consists of a 2 mL
glass via l providing 40 mg (0.8 mL) of HUMIRA, and one sterile syringe with a fixed 27
gauge ½ inch needle (with needle stick protection device). The NDC number is 0074-
3797-01.
REFERENCES
1. Arnett FC, Edworthy SM, Bloch DA, et. al. The American Rheumatology
Association 1987 Revised Criteria for the Classification of Rheumatoid Arthritis.
Arthritis Rheum 1988; 31:315-24.
2. Ramey DR, Fries JF, Singh G. The Health Assessment Questionnaire 1995 -
Status and Review. In: Spilker B, ed. “Quality of Life and Pharmacoeconomics in
Clinical Trials.” 2nd ed. Philadelphia, PA. Lippincott-Raven 1996.
3. Ware JE, Gandek B. Overview of the SF-36 Health Survey and the International
Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol 1998; 51(11):903-
12.
4. Mellemkjaer L, Linet MS, Gridley G, et al. Rheumatiod Arthritis and Cancer
Risk. European Journal of Cancer 1996; 32A (10): 1753-1757.
5. Baecklund E, Ekbom A, Sparen P, et al. Disease Activity and Risk of Lymphoma
in Patients With Rheumatoid Arthritis: Nested Case-Control Study. BMJ 1998;
317: 180-181.
6. Centers for Disease Control and Prevention. Targeted Tuberculin Testing and
Treatment of Latent Tuberculosis Infection. MMWR 2000; 49(No. RR-6):26-38.
Issued: December 2002
U.S. Govt. Lic. No. 0043

[Michgirl]

fishinghat - You are amazing.  To look into that and report it all is such a blessing even to those of us just reading.  Thank you.

[fishinghat]

Thanks Michgirl!!

 

What is amazing is that when I went through the medical articles on Humira that is has been linked to dozens and dozens of serious conditions including heart failure and death. I will probably post that stuff tomorrow but I can tell you that Humira makes Cymbalta seem like and ice cream cone. Nasty stuff.

[fishinghat]

I hope Stephanie sees this post and reads it. The effects of this medicine is incredible.

Humira (Adalimumab) Research
Note - In research papers Adalimumab is sometimes abbreviated ADL or ADA.
https://www.ncbi.nlm...les/PMC4716561/
A multicentre, randomised, controlled, open-label pilot study on the feasibility of discontinuation of adalimumab in established patients with rheumatoid arthritis in stable clinical remission
"Remission was rarely maintained in patients with long-standing disease who discontinued ADA. Discontinuation may be feasible in only a minority of patients with established RA in stable clinical remission."

https://www.ncbi.nlm...pubmed/26799728
Adalimumab-induced apoptotic enteropathy.
"Here we present a case of apoptotic enteropathy (AE) in a patient with ulcerative colitis, who was being treated with Adalimumab."
apoptotic enteropathy -genetically determined process of cell self-destruction that is marked by the fragmentation of nuclear DNA in the intestional tract.

https://www.ncbi.nlm...pubmed/26774942
[Spontaneous regression of multiple squamous cell carcinomas after discontinuation of adalimumab and methotrexate].

https://www.ncbi.nlm...pubmed/26765401
A Case Report of Majocchi's Granuloma Associated with Combined Therapy of Topical Steroids and Adalimumab.
Majocchi's Granuloma is a form of tinea corporis seen mainly on the lower legs, due to infection of hairs by the fungus Trichophyton; characteristics include raised, circumscribed, boggy granulomas that are disseminated or arranged in chains. Lesions are slowly absorbed or undergo necrosis, leaving depressed scars.

https://www.ncbi.nlm...pubmed/26645047
Dermatofibrosarcoma protuberans (DFSP) with fibrosarcomatous changes in a patient with psoriasis treated with adalimumab.
Dermatofibrosarcoma protuberans: (DFSP) A type of skin tumor that begins as a hard nodule and grows slowly. DFSP is usually found in the dermis of the limbs or trunk of the body. (The dermis is the inner layer of the two main layers of tissue that make up the skin.) DFSP can grow and invade surrounding tissues but typically it does not metastasize (spread) to other more distant parts of the body.

https://www.ncbi.nlm...les/PMC4696966/
Pulmonary Sarcoidosis Induced by Adalimumab: A Case Report and Literature Review
Pulmonary Sarcoidosis is a disease which causes the development of granulomas in the lungs. Granulomas are masses resembling little tumors. They are made up of clumps of cells from the immune system.

https://www.ncbi.nlm...pubmed/26613768
Comparison of lipid and lipid-associated cardiovascular risk marker changes after treatment with tocilizumab or adalimumab in patients with rheumatoid arthritis.
LDL-C and HDL-C increased with adalimumab.
These are forms of cholesterol.
https://www.ncbi.nlm...pubmed/26566776
Cerebral tuberculoma with pulmonary tuberculosis in a patient with psoriasis treated with adalimumab, an anti-tumor necrosis factor-α agent.
Cerebral tuberculoma - A rounded tumorlike but nonneoplastic mass in the brain, due to localized tuberculous infection.

https://www.ncbi.nlm...pubmed/26476903
Scabies in a Patient with Rheumatoid Arthritis Treated with Adalimumab - A Case Report.
"The patient was treated with topical 10% crotamiton. The symptoms were persistent and additional applications of the preparation were needed. After clinical remission of scabies, treatment of active rheumatoid arthritis with adalimumab was restarted without any complications. "
Scabies is a relatively contagious infection caused by a tiny mite(Sarcoptes scabiei).

https://www.ncbi.nlm...pubmed/26461828
Psoriasiform Eruption Secondary to the Use of Adalimumab
(Skin eruptions resembling psoriasis.

https://www.ncbi.nlm...pubmed/26368546
Observational case series on adalimumab-induced paradoxical hidradenitis suppurativa.
Paradoxical hidradenitis suppurativa -is a chronic skin condition that features pea-sized to marble-sized lumps under the skin. Also known as acne inversa, these deep-seated lumps typically develop where skin rubs together — such as the armpits, groin, between the buttocks and under the breasts. The lumps associated with hidradenitis suppurativa are usually painful and may break open and drain foul-smelling pus. In many cases, tunnels connecting the lumps will form under the skin.

https://www.ncbi.nlm...pubmed/26366160
Seborrhoeic dermatitis and a herpes zoster infection developed during treatment with adalimumab due to Crohn's disease.

https://www.ncbi.nlm...pubmed/26365982
Development of Crescentic Immunoglobulin A Nephritis and Multiple Autoantibodies in a Patient during Adalimumab Treatment for Rheumatoid Arthritis.
Crescentic Immunoglobulin A Nephritis - any glomerular disease characterized by extensive crescents (usually >50%) as the principal histologic finding and by a rapid loss of renal (kidney) function (usually a 50% decline in the glomerular filtration rate [GFR] within 3 mo) as the clinical correlate.

https://www.ncbi.nlm...pubmed/26312693
Drug-induced lupus with leukocytoclastic vasculitis: a rare expression associated with adalimumab.

https://www.ncbi.nlm...pubmed/26250408
Palmoplantar pustular psoriasis induced by adalimumab: a case report and literature review.

https://www.ncbi.nlm...pubmed/26253752
[Peripheral corneal melting syndrome in psoriatic arthritis treated with adalimumab].
Peripheral corneal melting syndrome - is a rare disease consisting of marginal corneal thinning that can progress to perforation.

https://www.ncbi.nlm...pubmed/26201378
Adalimumab-induced porokeratosis.
Porokeratosis is a progressive autosomal dominant skin disorde and characterized clinically by the presence of craterlike patches that have central atrophy with an elevated thick keratotic border and enlarge to form lesions.

https://www.ncbi.nlm...pubmed/26166141
Time Course and Clinical Implications of Development of Antibodies Against Adalimumab in Patients With Inflammatory Bowel Disease.
Antibodies against ADL appear in approximately one fourth of inflammatory bowel disease patients with decreasing frequency over time and usually within 1 year of therapy. Anti-ADL Abs generally persist during continued ADL therapy, and are associated with elimination of drug and treatment failure. Therefore, ADL cessation should be considered when anti-ADL Abs are detected and supported by clinical observations.
Note -The above is important. Many patients on Humira develop antibodies that fight the drug. This leads to ultimate failure of the treatment and discontinuation of the treament. There are many research articles documenting this effect. Around 24% of AS patients develop significant antibodies and failure of treatment. Some more links to these type of articles are listed below.
https://www.ncbi.nlm...pubmed/25974288
https://www.ncbi.nlm...pubmed/25942310
https://www.ncbi.nlm...pubmed/25862647
https://www.ncbi.nlm...pubmed/25807089
https://www.ncbi.nlm...pubmed/25795267........ and many more

https://www.ncbi.nlm...pubmed/26158363
Repigmentation of hair following adalimumab therapy.
"Repigmentation of canities, or age-related grey or white hair, is a rare occurrence. Generalized repigmentation of grey-white hair has been reported following inflammatory processes, and heterochromia (localized patches of hair repigmentation) is even more unusual, reported in association with medication use and malignancy. Tumor necrosis factor (TNF) inhibitors are increasingly utilized medications for inflammatory disorders, including psoriasis, rheumatoid arthritis, and inflammatory bowel disease. Hair loss, or alopecia, has been described among the side effects of these medications, but changes in hair pigmentation in association with this class of drugs have not previously been reported. We describe a patient with hair repigmentation associated with adalimumab therapy."

https://www.ncbi.nlm...pubmed/26047709
Oral Squamous Cell Carcinoma Presenting in a Patient Receiving Adalimumab for Rheumatoid Arthritis.
(oral cancer)

https://www.ncbi.nlm...les/PMC4456692/
Systemic adalimumab induces peripheral corneal infiltrates: a case report
Cornea developes infiltrating bodies.

https://www.ncbi.nlm...pubmed/26040057
Autoimmune hepatitis triggered by adalimumab and allergic reactions after various anti-TNFα therapy agents in a patient with rheumatoid arthritis.

https://www.ncbi.nlm...pubmed/26023062
Periappendicitis during adalimumab treatment for ileocecal Crohn's disease in a 29-year-old male.

https://www.ncbi.nlm...pubmed/26003376
[Cutaneous lesions in a woman treated with adalimumab].

https://www.ncbi.nlm...pubmed/25948357
Autoimmune hemolytic anemia during adalimumab treatment for plaque psoriasis.

https://www.ncbi.nlm...pubmed/25845414
Adalimumab-Induced Cutaneous Lupus Erythematosus in a 16-Year-Old Girl with Juvenile Idiopathic Arthritis.
https://www.ncbi.nlm...pubmed/25832955
Central nervous system manifestations of tuberculosis-associated immune reconstitution inflammatory syndrome during adalimumab therapy: a case report and review of the literature.
A 64-year-old neurologically asymptomatic woman with rheumatoid arthritis who was treated with the tumor necrosis factor (TNF)-α antagonist adalimumab developed disseminated tuberculosis (TB). After receiving anti-TB therapy and discontinuing adalimumab, she exhibited paradoxical worsening due to immune reconstitution inflammatory syndrome (IRIS) with the appearance of meningitis and brain tuberculomas. This case indicates that continuing anti-TNF therapy may be necessary to prevent IRIS in patients who develop TB, particularly disseminated TB, during the course of anti-TNF therapy. In addition, careful screening for central nervous system (CNS) TB should be performed prior to the initiation of therapy, as even neurologically asymptomatic patients can develop CNS manifestations of IRIS.

https://www.ncbi.nlm...pubmed/25807724
Adalimumab-induced lichenoid drug eruption.
We present a case report of a 26-year-old male patient who developed a lichenoid drug eruption few months after the initiation of adalimumab for the management of Crohn's disease.

https://www.ncbi.nlm...pubmed/25807103
Severe dilated cardiomyopathy induced by adalimumab and ustekinumab.
Cardiomyopathy is a chronic disease of the heart muscle (myocardium), in which the muscle is abnormally enlarged, thickened, and/or stiffened. The weakened heart muscle loses the ability to pump blood effectively, resulting in irregular heartbeats (arrhythmias) and possibly even heart failure.
https://www.ncbi.nlm...pubmed/25739794
Adalimumab-induced lupus serositis.
https://www.ncbi.nlm...pubmed/25717268
Adalimumab-induced interstitial pneumonia in a patient with Crohn's disease.

Note there are literally dozens of other articles out there that record barious conditions caused by adalimumab, some can even be fatal (eg. cardiomyopathies...)


Ankylosing Spondylitis And Adalimumab Specific Information.

https://www.ncbi.nlm...pubmed/26727457
Search for a concentration-effect curve of adalimumab in ankylosing spondylitis patients.

https://www.ncbi.nlm...pubmed/26475377
Posterior reversible encephalopathy syndrome (PRES) in a patient taking adalimumab for spondyloarthritis.
Posterior reversible encephalopathy syndrome is a syndrome characterized by headache, confusion, seizures and visual loss. On a MRI of the brain, areas of edema (swelling) are seen.

https://www.ncbi.nlm...pubmed/26414004
Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods.
Significant improvement in 16 weeks.

https://www.ncbi.nlm...les/PMC4653233/
Clinical characteristics of Japanese patients with axial spondyloarthritis, and short-term efficacy of adalimumab
A "must read article" good background info.

https://www.ncbi.nlm...pubmed/26222847
Effectiveness of Adalimumab in Non-radiographic Axial Spondyloarthritis: Evaluation of Clinical and Magnetic Resonance Imaging Outcomes in a Monocentric Cohort.
"Modified Stoke Ankylosing Spondylitis Spine Score and Spondyloarthritis Research Consortium of Canada scores showed a trend of improvement during the study period.ADA was effective on clinical and radiological outcomes at 2-year follow-up; thus, early treatment with ADA may prevent radiographic damage and be associated with low disease activity or remission. Moreover, data from this cohort study have confirmed safety and tolerability profile of ADA in nr-axSpA in the long term."

https://www.ncbi.nlm...pubmed/25967132
Factors affecting discontinuation of adalimumab and etanercept therapy in anti-TNF-naïve patients with ankylosing spondylitis: Nationwide population-based cohort study.
'Overall, the ADA and ETN groups had similar risk for drug discontinuation. In each group, concomitant use of methotrexate (MTX) or a non-steroidal anti-inflammatory drug was associated with a lower risk of discontinuation. Subgroup analysis indicated that concomitant MTX use reduced risk of discontinuation of ADA.'

https://www.ncbi.nlm...pubmed/25910480
Efficiency of adalimumab, etanercept and infliximab in ankylosing spondylitis in clinical practice.
A total of 119 patients (137 cases) were included (28 cases treated with adalimumab, 48 cases with etanercept and 61 with infliximab). Mean doses of adalimumab and etanercept were 92.8 and 88.8% of the initially prescribed doses, respectively, while the mean dose of infliximab administered was 102%. There were no statistical differences among treatments in terms of clinical effectiveness. Associated mean patient-year costs were significantly higher in the infliximab group compared to the other treatments.
In certain ankylosing spondylitis patients, doses and associated costs of biological therapies can be reduced while controlling disease activity. Mean doses used in our clinical practice vary from the recommended doses and are significantly lower for adalimumab and etanercept than for infliximab. These differences impact directly on associated patient-year costs, and, thus, on treatment efficiency.

https://www.ncbi.nlm...pubmed/25541333
Maintenance of improvement in spinal mobility, physical function and quality of life in patients with ankylosing spondylitis after 5 years in a clinical trial of adalimumab.
Treatment with adalimumab for up to 5 years demonstrated sustained benefits in spinal mobility, disease activity, physical function and HRQoL in patients with active AS. Spinal mobility was significantly associated with short- and long-term physical function in these patients.
https://www.ncbi.nlm...pubmed/24506823
Randomized, placebo controlled and double-blind trials of efficacy and safety of adalimumab for treating ankylosing spondylitis: a meta-analysis.
This meta-analysis shows a higher efficacy of adalimumab relative to placebo, but clinicians should be careful regarding adverse events in adalimumab-treated patients.

https://www.ncbi.nlm...pubmed/23269571
Multiple sclerosis during adalimumab treatment in a case with ankylosing spondylitis.

https://www.ncbi.nlm.nih.gov/pubmed
Adalimumab significantly reduces the recurrence rate of anterior uveitis in patients with ankylosing spondylitis.
Uveitis is an inflammation of the uveal tract, which lines the inside of the eye behind the cornea.

[fishinghat]

I found dozens more of similar articles on Humira but it was just too much to post. If anyone is considering this drug (I hope not) or has any questions, let me know.

[TryinginFL]

Great info, FH - many thanks!

 

Ugh