Safety and Effectiveness of Adalimumab for the Treatment of Pyoderma Gangrenosum: A 52-Week Real-World Prospective Observational Study - Summary - MDSpire

Safety and Effectiveness of Adalimumab for the Treatment of Pyoderma Gangrenosum: A 52-Week Real-World Prospective Observational Study

  • By

  • Toshiyuki Yamamoto

  • Hideaki Tanizaki

  • Kenshi Yamasaki

  • Naoko Matsubara

  • Masahiko Nakayama

  • Eri Iwashita

  • Keiichi Yamanaka

  • May 10, 2026

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Objective:

To evaluate the safety and effectiveness of adalimumab over 52 weeks in Japanese patients with pyoderma gangrenosum (PG), including those with prior TNF-α inhibitor exposure and concomitant steroid use.

Key Findings:
  • Adalimumab was well tolerated with no new safety concerns identified.
  • Adverse drug reactions (ADRs) occurred in 14.9% of patients, with serious ADRs in 9.0%.
  • 57.7% of patients achieved a Physician Global Assessment score of 0/1, indicating complete or near-complete healing.
Interpretation:

The findings support the use of adalimumab in broader clinical settings, particularly for patients with large lesions and those on systemic steroids, suggesting its potential for diverse patient profiles.

Limitations:
  • The study was limited to a single country and may not represent global populations.
  • Exclusion of patients previously treated with adalimumab for PG may limit generalizability and the understanding of its long-term effects.
Conclusion:

Adalimumab is a safe and effective treatment option for PG, warranting its use in diverse patient profiles.

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