CHMP recommends Humira (adalimumab) to treat hidradenitis suppurativa- AbbVie
The European Medicines Agency (EMA) has recommended extending the use of Humira (adalimumab) from AbbeVie to include treatment of adults with active moderate to severe hidradenitis suppurativa (acne inversa), who have failed to respond to conventional systemic treatments. Hidradenitis supportiva is a chronic skin disease that causes abscesses and scarring on the skin � usually around the groin, buttocks, breasts and armpits. Humira is the first medicine that is recommended for approval for the treatment of this disease in the European Union (EU).
The positive opinion is based on the results of two pivotal Phase III studies, PIONEER I and PIONEER II. These studies demonstrated that moderate to severe HS patients treated with Humira 40 mg weekly starting at Week 4 following 160 mg at Week 0 and 80 mg at Week 2 achieved a significantly greater response versus those on placebo at 12 weeks using the Hidradenitis Suppurativa Clinical Response (HiSCR) measure.
This is defined as at least 50 percent reduction from baseline in total abscess and inflammatory nodule (AN) count with no increase for either abscess or draining fistula count.Additionally, at Week 12, a significantly higher proportion of Humira treated patients in PIONEER II experienced a clinically relevant decrease in HS-related skin pain (as measured by >30% Reduction in Skin Pain) compared to those on placebo.4 No new safety signals were identified in these trials.
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