Pyoderma Gangrenosum That Did Not Respond to Systemic Therapy

This protocol addresses active pyoderma gangrenosum (PG) where initial systemic treatment has not achieved the expected ulcer response. When standard systemic therapy fails to produce adequate improvement within the defined timeframe, a structured escalation step applies.

Prior Treatment — Goals Not Achieved

The previous treatment line consisted of systemic therapy with an oral corticosteroid (prednisolone) or an immunosuppressant (cyclosporine). The anticipated outcomes — reduction of the skin ulcer area within 6 weeks and complete ulcer healing within 6 months — were not reached, meeting the criteria for escalation to this protocol.

Next-Step Treatment Approach

For PG resistant to oral corticosteroids and immunosuppressants, the protocol involves anti-TNF biologic therapy. The specific agents considered, the selection criteria, and the full clinical decision algorithm are contained in the complete structured regimen.

Treatment Goal

The primary clinical target is complete resolution of the PG ulcer — defined as 100% reduction of the target ulcer area (PGAR100) — evaluated at week 26 of treatment.

References

DOI: 10.1111/1346-8138.16845

Presently, experience of the use is richest in anti-TNF preparations.
As a result, adalimumab was approved first in Japan as a drug for PG covered by health insurance in 2020.
PGAR100 of target PG ulcers, which was the primary endpoint, was achieved in 12 of 22 patients with active ulcerative PG (p<0.001 at week 26 of administration).

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