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General Information

Humira (adalimumab) is a tumor necrosis factor (TNF) blocker.

Humira is specifically indicated for the following:

to reduce the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adults, either alone, with methotrexate, or with certain other medicines;
to reduce the signs and symptoms of moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older, alone or with methotrexate;
to reduce the signs and symptoms of Psoriatic arthritis (PsA) in adults, alone or with certain other medicines; .
to reduce the signs and symptoms of Ankylosing spondylitis (AS) in adults;
to reduce the signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in people 12 years and older;
to treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older;
to treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older;
to treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate;
to treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

Humira is supplied as an injection for subcutaneous use. Please see drug label for dosing specifications for each therapeutic indication.

Clinical Results

Rheumatoid Arthritis: The FDA approval of Humira for rheumatoid arthritis was based on four randomized, double blind studies. Humira was administered subcutaneously in combination with MTX or as monotherapy or with other disease modifying anti-rheumatic drugs. Study I evaluated 271 subjects whom 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 Subjects 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 Subjects who had an inadequate response to MTX. Subjects 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. Study IV assessed safety in 636 Subjects 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. Subjects were randomized to 40 mg of Humira or placebo every other week for 24 weeks. In all four studies, Humira showed significantly greater improvement than placebo in the disability index of Health Assessment Questionnaire 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. Improvement was seen in both the Physical Component Summary and the Mental Component Summary.

Uveitis: The FDA approval of Humira for non-infectious intermediate, posterior and panuveitis was based on two randomized, double-masked, placebo-controlled studies (UV I and II). Patients received placebo or Humira at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose. The primary efficacy endpoint in both studies was time to treatment failure. Study UV I evaluated 217 patients with active uveitis while being treated with corticosteroids (oral prednisone at a dose of 10 to 60 mg/day). All patients received a standardized dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by Week 15. Study UV II evaluated 226 patients with inactive uveitis while being treated with corticosteroids (oral prednisone 10 to 35 mg/day) at baseline to control their disease. Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week 19. Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with Humira versus patients receiving placebo,(percentage in failure). Study UV I: Humira (54.5%) versus placebo (78.5%). Study UV II: Humira (39.1%) versus placebo (55%).

Psoriatic Arthritis: The Humira approval is based on results of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), studied 313 adult patients with moderately to severely active PsA who had an inadequate response to NSAID (non-steroidal anti-inflammatory drug) therapy. Humira patients experienced significantly greater improvement in both joint and skin disease symptoms than placebo-treated patients at 24 weeks. Improvements in both skin lesions and joint symptoms were seen as early as two weeks after initiation of treatment and continued to improve over time. Approximately 60 percent of patients achieved ACR20 at week 12, one of the study's primary endpoints, and with a sustained response through week 24. ACR70 was achieved by nearly 25 percent of patients treated with Humira vs. 1 percent of patients treated with placebo at week 24.

Ankylosing Spondylitis: The approval of Humira for the treatment of patients with active AS was based on data from the ATLAS (Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS) trial. The randomized, placebo-controlled, double-blind, Phase III study was conducted in Europe and the United States. Humira was successful in reducing pain and inflammation in patients with AS after 12 weeks of treatment, the study’s primary endpoint. Other findings demonstrated significant improvement in measures of disease activity for many patients treated with Humira that were first observed at week two and maintained through 24 weeks.

Crohn's Disease: The FDA approval was based on the CLASSIC I, CHARM and GAIN trials in more than 1,400 adult patients with moderately to severely active Crohn's disease. The CLASSIC I induction trial evaluated the ability of Humira to induce remission. Of 299 anti-TNF naive patients, 36 percent of patients receiving Humira (160 mg at week zero followed by 80 mg at week two) achieved clinical remission at week four compared to 12 percent treated with placebo. The CHARM trial studied the ability of Humira to maintain clinical remission. CHARM was a 56-week trial that enrolled 854 patients with moderate to severe Crohn's disease. During a four-week open label induction phase, 58 percent of patients (499) demonstrated clinical response to Humira (a CDAI decrease equal to or greater than 70 from baseline). These patients were randomized to receive either Humira 40 mg every other week (eow), Humira 40 mg weekly, or placebo. Of those who continued on Humira 40 mg every other week, 40 percent were in clinical remission at week 26 (p<0.001) and 36 percent were in remission at week 56 (p<0.001), versus 17 percent and 12 percent of patients in the placebo group, respectively. GAIN was a four-week induction trial of 325 patients who lost response or were intolerant to infliximab, three times as many patients taking Humira achieved clinical remission at week four versus placebo (21 percent versus 7 percent).

Crohn's disease in pediatric patients: The FDA approval was based on IMAgINE-1, a multi-center, randomized, double-blind anti-TNF trial in patients 6 to 17 years of age (n=192) with moderately to severely active Crohn's disease for whom conventional treatment was unsuccessful. Patients received open-label induction therapy with subcutaneous adalimumab at weeks 0 and 2 (160 mg and 80 mg, or 80 mg and 40 mg, for body weight ≥40 kg or <40 kg). At week 4, 188 patients were assigned to groups based on achievement of clinical response (defined as decrease in PCDAI ≥15 points from baseline; 155/188 [82.4%]) and prior exposure to infliximab (82/188 [43.6%]). Groups were given double-blind maintenance therapy with adalimumab at high (40 mg or 20 mg for body weight ≥40 kg or <40 kg; n = 93) or low doses (20 mg or 10 mg for body weight ≥40 kg or <40 kg; n = 95) every other week for 48 weeks. The primary endpoint was clinical remission (PCDAI ≤10) at week 26, compared between groups. A total of 152 of 188 patients (80.9%) completed all 26 weeks of the study. At week 26, 63 patients (33.5%) were in clinical remission, with no significant difference between high- and low-dose groups (36/93 [38.7%] vs 27/95 [28.4%].

Plaque Psoriasis: The approval of Humira for plaque psoriasis was based on data from two pivotal trials -- REVEAL and CHAMPION. In each trial, reduction in disease activity was determined by the Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA). REVEAL was a pivotal 52-week trial. The short-term and sustained clinical efficacy and safety of Humira were evaluated in more than 1,200 patients with moderate to severe chronic plaque psoriasis from the United States and Canada. 71% of patients receiving Humira achieved PASI 75 compared to 7 percent of patients receiving placebo at week 16. At week 16, 62 percent of Humira-treated patients achieved a PGA score of clear or minimal (0 or 1) compared to 4 percent of placebo-treated patients. CHAMPION was a pivotal 16-week study evaluating 271 psoriasis patients from eight European countries and Canada. CHAMPION also compared Humira to methotrexate, a standard systemic treatment for psoriasis. Humira-treated patients experienced a significant reduction in the signs and symptoms of their disease compared with methotrexate or placebo-treated patients. 78% of patients treated with Humira (n=99) achieved a PASI 75 response, compared to 19 percent of patients treated with placebo (n=48). 71% of patients treated with Humira achieved a PGA score of clear or minimal at 16 weeks of treatment, compared with only 10 percent of placebo-treated patients.

Polyarticular juvenile idiopathic arthritis: The FDA approval was based on the results of a 48-week phase 3 study and a subsequent open-label extension evaluating the efficacy and safety of Humira. The 48-week study included 171 children (four to 17 years of age) with polyarticular JIA. In the first part of this study, two groups of patients -- those taking methotrexate (MTX) and those not taking MTX -- received open-label Humira (up to a maximum of 40 mg) every other week for 16 weeks. Patient responses were measured using the of Rheumatology Pediatric (ACR Pedi) 30 score, which represents a 30 percent or greater improvement in JIA signs and symptoms. Patients who showed a positive clinical response (n=133) entered the second part of the study and were randomized to receive Humira or placebo for an additional 32 weeks or until disease flare. In the second part of this study, significantly fewer patients receiving Humira demonstrated disease flare compared to children on placebo, both without MTX (43 percent vs. 71 percent) and with MTX (37 percent vs. 65 percent). Additionally, more patients treated with Humira continued to show ACR Pedi 30/50/70 responses at week 48 compared to placebo. The ACR Pedi responses were maintained for up to two years in patients who received Humira throughout the study.

Ulcerative colitis: The FDA approval was based on two clinical studies. A total of 908 patients who had never been treated with a TNF-blocker, or who lost response to or were intolerant to TNF-blockers were enrolled in the studies. All patients had a Mayo score of 6 to 12 and an endoscopy subscore of 2 to 3. Patients were randomly assigned to take Humira or a placebo. The studies were designed to measure the percentage of patients whose Mayo score decreased to 2 or less with no individual subscore of more than 1 after eight weeks of treatment. Patients who obtained such reductions in the Mayo score were determined to have achieved clinical remission. Results from both studies showed 16.5 percent to 18.5 percent of patients treated with Humira achieved clinical remission compared with 9.2 percent to 9.3 percent of patients receiving placebo. Additionally, in the second study, 8.5 percent of patients treated with Humira sustained clinical remission compared with 4.1 percent of patients treated with placebo.

Pediatrics with ulcerative colitis: FDA approval was based on ENVISION I, a Phase 3, randomized, double-blind, multicenter study designed to evaluate the efficacy, safety and the pharmacokinetics of Humira in pediatric patients (ages 4-17) with moderate to severe ulcerative colitis (defined as a FMS of 6 to 12 with endoscopy subscore of 2 to 3 points, confirmed by centrally read endoscopy), administered subcutaneously. Through Week 8, patients in both dosage groups received 2.4 mg/kg (maximum of 160 mg) at Week 0, 1.2 mg/kg (maximum of 80 mg) at Week 2, and 0.6 mg/kg (maximum of 40 mg) at Weeks 4 and 6. The higher dosage group also received an additional dosage of 2.4 mg/kg (maximum of 160 mg) at Week 1. Between Week 8 and Week 52, patients received double-blind placebo, Humira 0.6 mg/kg (maximum of 40 mg) every other week, or every week. The co-primary endpoints of the study were clinical remission per PMS (defined as PMS ≤ 2 and no individual subscore > 1) at Week 8, and clinical remission per the Mayo Score (defined as Mayo Score ≤ 2 and no individual subscore > 1) at Week 52 in patients who achieved clinical response per PMS at Week 8. Study results demonstrated 60 percent [28/47] of patients taking the higher dosage of Humira achieved clinical remission per PMS, at the end of the 8-week induction period and 43 percent [13/30] of patients in the lower dosage group. At Week 52, among Week 8 PMS responders, 45 percent [14/31] of patients receiving the higher dosage of Humira achieved remission per FMS and 29 percent [9/31] of patients taking the lower dosage of Humira and 33 percent [4/12] of those randomized to placebo.

Hidradenitis suppurativa: The FDA approval was based on the results of two pivotal Phase 3 studies, PIONEER I (n=307) and PIONEER II (n=326), similarly designed, multicenter trials with two double-blind, placebo-controlled periods. In period 1, patients were randomly assigned in a 1:1 ratio to 40 mg of adalimumab weekly or matching placebo for 12 weeks. In period 2, patients were reassigned to adalimumab at a weekly or every-other-week dose or to placebo for 24 weeks. The primary end point was a clinical response, defined as at least a 50% reduction from baseline in the abscess and inflammatory-nodule count, with no increase in abscess or draining-fistula counts, at week 12. Clinical response rates at week 12 were significantly higher for the groups receiving adalimumab weekly than for the placebo groups: 41.8% versus 26.0% in PIONEER I and 58.9% versus 27.6% in PIONEER II. Patients receiving adalimumab had significantly greater improvement than the placebo groups in rank-ordered secondary outcomes (lesions, pain, and the modified Sartorius score for disease severity) at week 12 in PIONEER II only.

Side Effects

Adverse effects associated with the use of Humira may include, but are not limited to, the following:

infections (e.g. upper respiratory, sinusitis)
injection site reactions
headache
rash

Humira comes with a black box warning of an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Humira use may also lead to an increased risk for developing malignancy.

Mechanism of Action

Humira (adalimumab) is a tumor necrosis factor (TNF) blocker. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.