AbbVie announced that Health Canada approved HUMIRA® (adalimumab) for the treatment of adults with active moderate to severe hidradenitis suppurativa (HS), who have not responded to conventional therapy (including systemic antibiotics). This follows approval from the Food and Drug Administration (FDA) and the European Commission. HUMIRA is now the first and only Health Canada-approved therapy for the treatment of adults living with HS.

HS is a chronic, systemic, immune-mediated skin disease which affects between 1 to 3% of the global population however the diagnosis is often delayed or the condition is misdiagnosed with the true prevalence unknown. In general, HS has a greater impact on the quality of life of affected individuals compared to other dermatological conditions. 2 The average Canadian HS patient will see five doctors with over 17 visits spanning eight years before being diagnosed.

HS is associated with intense pain, decreased mobility, and the deep-seated lesions (nodules or abscesses) may be accompanied by unpleasant odor and purulent drainage. The lesions are present under the arms, groin, and perianal area with the breasts being affected in female individuals. With time, the lesions can be clustered with residual scarring.

Health Canada's approval for the treatment of HS adds to the comprehensive record of clinical studies that HUMIRA has established over its 11 years of use in immunology in Canada. This latest Health Canada approval is based on the results of two pivotal Phase 3 studies, PIONEER I and PIONEER II, and represents the ninth approved indication for HUMIRA in Canada. PIONEER I and PIONEER II included 633 patients with moderate to severe HS.

Patients in these studies were randomly assigned to receive either HUMIRA or placebo in addition to daily use of topical antiseptic. Both studies showed that more patients given HUMIRA had reductions in the total number of abscesses and inflammatory nodules than patients given placebo. No new safety risks were identified in these trials.