Data Limitation: Clinical remission and response rates were numerically higher in the High Maintenance Dose Group compared with the Low Maintenance Dose Group, and those differences were either not statistically significant or exploratory.
This trial did not have a placebo control arm.1,2
Study Design Intro: A multicenter, 4-week, open-label induction followed by 52-week, double-blind, randomized, maintenance study of 2 dose levels of HUMIRA in moderate to severe pediatric CD in patients (PCDAI score >30) who had, over the previous 2-year period, an inadequate response to or intolerance to corticosteroids or an immunomodulator. Patients who previously had loss of response to or intolerance to infliximab were allowed entry to trial. Clinical remission and response rates were numerically higher in the High Maintenance Dose group compared with the Low Maintenance Dose Group, and those differences were either not statistically significant or exploratory.
The endpoint was a comparison of the High Maintenance Dose vs. the Low Maintenance Dose. Only the High Maintenance Dose results are depicted.1,2
PCDAI=Pediatric Crohn’s Disease Activity Index
*Clinical remission was defined as PCDAI score of ≤10.
†Clinical response was defined as a decrease in PCDAI score of ≥15 points from baseline.
‡Bio-naïve and bio‑experienced refers to patients that were infliximab‑naïve and infliximab‑experienced.
Those treated with HUMIRA experienced long‑term remission at Weeks 26 and 52 in the largest double-blind study to date of an anti‑TNF in pediatric CD patients1,2
Dosing based on Week 4 weight
(<40 kg=20 mg, ≥40 kg=40 mg); every other week (EOW)
Patients Were 55% Bio-naïve and
45% Bio-experienced
Study Design Intro: A multicenter, 4-week, open-label induction followed by 52-week, double-blind, randomized, maintenance study of 2 dose levels of HUMIRA in moderate to severe pediatric CD in patients (PCDAI score >30) who had, over the previous 2-year period, an inadequate response to or intolerance to corticosteroids or an immunomodulator. Patients who previously had loss of response to or intolerance to infliximab were allowed entry to trial. Clinical remission rates were numerically higher in the High Maintenance Dose group compared with the Low Maintenance Dose Group, and those differences were either not statistically significant or exploratory.
The endpoint was a comparison of the High Maintenance Dose vs. the Low Maintenance Dose. Only the High Maintenance Dose results are depicted.1,2
Adverse events in IMAgINE 1 study population (n=192)2
PCDAI=Pediatric Crohn’s Disease Activity Index; TNF=tumor necrosis factor
*Clinical remission was defined as PCDAI score of ≤10.
Pediatric CD patients treated with HUMIRA sustained response at Weeks 26 and 521
Dosing based on Week 4 weight
(<40 kg=20 mg, ≥40 kg=40 mg); every other week (EOW)
Patients Were 55% Bio-naïve and
45% Bio-experienced
Study Design Intro: A multicenter, 4-week, open-label induction followed by 52-week, double-blind, randomized, maintenance study of 2 dose levels of HUMIRA in moderate to severe pediatric CD in patients (PCDAI score >30) who had, over the previous 2-year period, an inadequate response to or intolerance to corticosteroids or an immunomodulator. Patients who previously had loss of response to or intolerance to infliximab were allowed entry to trial. Clinical response rates were numerically higher in the High Maintenance Dose group compared with the Low Maintenance Dose Group, and those differences were either not statistically significant or exploratory.
The endpoint was a comparison of the High Maintenance Dose vs. the Low Maintenance Dose. Only the High Maintenance Dose results are depicted.1,2
PCDAI=Pediatric Crohn’s Disease Activity Index
*Clinical response was defined as a decrease in PCDAI score of ≥15 points from baseline.
Statistical Considerations: These data were not powered or tested to demonstrate a statistically significant difference in treatment effect; no statistical inferences can be made due to the exploratory nature of the analysis.
*Clinical remission was defined as Pediatric Crohn's Disease Activity Index (PCDAI) score of ≤10.
†Bio‑naïve and bio‑experienced refers to patients that were infliximab‑naïve and infliximab‑experienced.
‡Clinical response was defined as a decrease in PCDAI score of ≥15 points from baseline.
Pediatric Crohn’s Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6‑mercaptopurine, or methotrexate.
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 (RA): 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 (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.
Psoriatic Arthritis (PsA): 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 (AS): HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Adult Crohn's Disease (CD): HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Pediatric Crohn's Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6‑mercaptopurine, or methotrexate.
Ulcerative Colitis (UC): HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6‑mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti‑TNF agents.
Plaque Psoriasis (Ps): 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 (HS): 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.
Please see full Prescribing Information.
References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Hyams JS, Griffiths A, Markowitz J, et al. Safety and efficacy of adalimumab for moderate to severe Crohn’s disease in children. Gastroenterology. 2012;143(2):365-374.