An update on adalimumab for pyoderma gangrenosum

Pyoderma gangrenosum is a refractory disease characterized by chronic ulcers, presenting with central deep ulceration and undermined borders predominantly involving the lower extremities. Oral prednisolone and/or cyclosporine has been considered to be a first line of therapy; however, there are still unmet needs for treatment. Recently, effects of adalimumab for pyoderma gangrenosum in 22 Japanese patients were examined in an open-label, multicenter study during a 26-week treatment period and a further 26-week extension period. Pyoderma gangrenosum area reduction 100 (PGAR 100, defined as complete skin re-epithelialization) response for the target ulcer was observed in 3 patients (13.6%) as early as week 6, and at week 26, 12 patients (54.5%) achieved the primary endpoint of PGAR 100. The mean percent change from baseline in target ulcer area was -63.8% at week 26. A physician's global assessment score of 0 (PGA 0) was achieved by 8 patients (36.4%), while PGA 0/1 (completely/almost clear) was achieved by 12 patients (54.5%) at week 26. Adverse events were reported by 18 patients, most commonly infections (n = 11) and serious adverse events (n = 4). These results suggest that adalimumab is effective and generally well tolerated in Japanese patients with pyoderma gangrenosum active ulcers.