Phase III results for Humira (adalimumab) show benefits in youngsters with chronic plaque psoriasis- AbbVie

AbbVie has announced new results from a pivotal Phase III study of Humira (adalimumab) demonstrating significant and clinically meaningful efficacy over methotrexate in children and adolescents with severe chronic plaque psoriasis. Results from the multi-site, international study found that at 16 weeks, a significantly higher proportion of pediatric patients with severe chronic plaque psoriasis treated with Humira 0.8mg/kg every other week achieved a Psoriasis Area Severity Index (PASI) 75 response as compared to patients treated with methotrexate (57.9 percent versus 32.4 percent).

Approximately 20 percent more patients treated with Humira (0.8mg/kg) achieved a Physicians Global Assessment (PGA) score of clear or minimal at 16 weeks compared to those treated with methotrexate (60.5 percent versus 40.5 percent). 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 (55.6 percent with 0.8mg/kg re-achieved PGA 0/1). Humira treatment had a similar safety profile to methotrexate with no new safety risks identified. The results were presented as part of the 23rd World Congress of Dermatology.

Comment: Enbrel has been replaced by Humira as the preferred first-line therapy in moderate to severe psoriasis, according to primary research conducted by Datamonitor Healthcare. The research also suggests that Stelara is gaining ground, while the field is being prepared for the advent of biosimilars.