AbbVie presents Phase 3 data demonstrating efficacy and safety of HUMIRA in children and adolescents with severe chronic plaque psoriasis
Posted: 10 June 2015 |
Results from a pivotal Phase 3 study of HUMIRA demonstrate significant and clinically meaningful efficacy in children and adolescents with plaque psoriasis…
AbbVie has announced new results from a pivotal Phase 3 study of HUMIRA® (adalimumab).
The results demonstrate significant and clinically meaningful efficacy over methotrexate in children and adolescents with severe chronic plaque psoriasis. This pivotal Phase 3 study supports the European Commission (EC) marketing authorisation for HUMIRA as the only biologic treatment approved in Europe for children and adolescents from four years of age with severe chronic plaque psoriasis who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Findings support HUMIRA as a safe and efficacious treatment option for the treatment of paediatric plaque psoriasis
“Psoriasis can have significant physical and psychological effects on the young patients it impacts,” said Kim Papp, M.D., Ph.D., study investigator, founder and president, Probity Medical Research, Waterloo, Ontario. “These findings support HUMIRA as a safe and efficacious first-line option for the treatment of severe paediatric plaque psoriasis when topical or phototherapies don’t work.”
Results from the multi-site, international study found that at 16 weeks, a significantly higher proportion of paediatric patients with severe chronic plaque psoriasis treated with HUMIRA every other week achieved a Psoriasis Area Severity Index (PASI) 75 response as compared to patients treated with methotrexate. Approximately 20% more patients treated with HUMIRA achieved a Physicians Global Assessment (PGA) score of clear or minimal at 16 weeks compared to those treated with methotrexate. Additionally, a high percentage of patients who initially responded to study treatment, but later progressed after treatment withdrawal, regained PGA clear or minimal response following treatment with HUMIRA during the 16 week retreatment phase. HUMIRA treatment had a similar safety profile to methotrexate with no new safety risks identified.
Research and treatment options are limited for the treatment of paediatric plaque psoriasis
“Research and treatment options are limited for this young population, so we are pleased to share new data that address a significant need in the treatment of paediatric plaque psoriasis,” said John Medich, Ph.D., vice president, clinical development, immunology, AbbVie. “These Phase 3 data build on more than 16 years of clinical research in HUMIRA, further establishing its safety and efficacy profile, even in young patients.”
The results were presented as part of the 23rd World Congress of Dermatology (WCD) in Vancouver.