For patients two years of age and older with moderate to severe polyarticular
juvenile idiopathic arthritis (JIA).
Model not an actual patient.
DE038 study design intro: Randomized, double‑blind, parallel‑group study of patients aged 4 to 17 years old with polyarticular JIA who were naïve to biologic DMARDs at baseline. The study consisted of a 16‑week, open‑label, lead‑in phase (Weeks 0 to 16), a 32‑week, double‑blind, withdrawal phase (Weeks 16 to 48), and an open‑label extension phase. Only patients who were ACR30 responders after the 16‑week, open‑label, lead‑in phase were randomized. In the double‑blind period, 133 patients were randomized to receive MTX + placebo (n=37), HUMIRA + MTX (n=38), HUMIRA (n=30), or placebo (n=28).* The primary endpoint was the percentage of patients not receiving MTX who had a disease flare† during the double‑blind phase of the study.1,2
*Body surface area (BSA) dose: HUMIRA 24 mg/m2 EOW up to a maximum dose of 40 mg EOW
†Disease flare=worsening of ≥30% from baseline in ≥3 of 6 pediatric ACR core criteria, ≥2 active joints, and an improvement of >30% in no more than 1 of 6 criteria
ACR=American College of Rheumatology; DMARDs=disease-modifying antirheumatic drugs; EOW=every other week; MTX=methotrexate
DE038—Patients 4 to 17 years of age with moderate to severe
polyarticular JIA who were naïve to biologic DMARDs1,2
aDisease flare=worsening of ≥30% from baseline in ≥3 of 6 pediatric ACR core criteria, ≥2 active joints, and an improvement of >30% in no more than 1 of 6 criteria
Significant reduction with HUMIRA compared to placebo for both monotherapy and in combination with MTX2
DE038—Patients 4 to 17 years of age with moderate to severe
polyarticular JIA who were naïve to biologic DMARDs1,2
aDisease flare=worsening of ≥30% from baseline in ≥3 of 6 pediatric ACR core criteria, ≥2 active joints, and an improvement of >30% in no more than 1 of 6 criteria
Significantly longer time with HUMIRA compared to placebo for both monotherapy and in combination with MTX.3
ACR=American College of Rheumatology; DMARDs=disease-modifying antirheumatic drugs; EOW=every other week; MTX=methotrexate
DE038—Patients 4 to 17 years of age with moderate to severe
polyarticular JIA who were naïve to biologic DMARDs1,2
ACR=American College of Rheumatology; DMARDs=disease-modifying antirheumatic drugs; EOW=every other week; MTX=methotrexate
DE038—Patients 4 to 17 years of age with moderate to severe
polyarticular JIA who were naïve to biologic DMARDs1,2
aPatient response during the first 104 weeks of the OLE phase regardless of whether HUMIRA was dosed according to body surface area (BSA) or body weight.2
bThe data are from the intent-to-treat population of 128 patients who entered the OLE phase of the study; for missing values, the last observation was carried forward.
As with any long-term open-label extension, there are several limitations with the OLE portion of this study. For example, there is the potential for enrichment of long-term data in the remaining patient population, as those who remain in the study generally fare better than those who discontinue.
DE038 OLE study design intro: Patients who enrolled in the double-blind phase were eligible to receive open-label treatment with HUMIRA in an extension phase of the study.2
ACR=American College of Rheumatology; OLE=open-label extension
Juvenile Idiopathic Arthritis (JIA): HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
Patients treated with HUMIRA are at 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.
Discontinue HUMIRA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T‑cell lymphoma (HSTCL), a rare type of T‑cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6‑mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
Rheumatoid Arthritis: HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
Juvenile Idiopathic Arthritis: HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
Ankylosing Spondylitis: HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Crohn’s Disease: HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
Ulcerative Colitis: HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
Limitations of Use:
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.
Plaque Psoriasis: HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
US-HUM-210183
Please see full Prescribing Information.
References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Lovell DJ, Ruperto N, Goodman S, et al. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008;359(8):810‑820. 3. Data on File. ABVRRTI62135. 4. Data on File. ABVRRTI65388.