DISCUSSION
pustulation, fatigue, pain
DISEASE, INFLAMMATION, SECONDARY
In the Effisayil™ 1 study of patients with a GPP flare, spesolimab treatment provided rapid and sustained improvements in GPPGA pustulation subscore and GPPGA total score compared with placebo, with an acceptable safety profile.The efficacy of spesolimab in Asian patients was also comparable to that in the overall population, with spesolimab providing a treatment benefit compared with placebo at Week 1 in terms of achievement of the primary and key secondary endpoints, and through sustained reductions in GPPGA scores up to Week 12. The percentages of Asian patients achieving a GPPGA pustulation subscore of 0 and a GPPGA total score of 0 or 1 at Week 1 (63% and 50%, respectively) were slightly higher than in the overall population (54% and 43%). However, caution must be taken when interpreting these results because no formal statistical comparisons were made; any numerical differences could be chance findings. Spesolimab also improved pain, fatigue, overall quality of life, and cutaneous symptoms in Asian patients, as assessed by PRO scales, and normalized markers of systemic inflammation. Such findings are in agreement with the improvements seen in the clinician‐reported GPPGA; a reduction in disease severity would be expected to lead to improvements in patient experience of GPP and a reduction in overall inflammation. When the GPPGA scores and PRO scales were analyzed according to the ITT principle, in which any use of open‐label spesolimab or other medication was included, improvements were seen over time, consistent with the primary results.These results compare favorably to those of other biologics studied for the treatment of GPP in Asian patients. Currently available treatments for GPP in Asia have displayed efficacy in GPP; however, as noted, the studies reporting these treatments are often open label and single arm or have enrolled fewer than 12 patients.The limitations of this study include the small number of patients enrolled and the even fewer patients in the subgroup analysis. No formal statistical comparisons could be made, meaning that caution is required when interpreting the findings. This is particularly the case for analyses involving fewer patients than the whole Asian population in the study; for example, although 67% and 60% of patients with and without In conclusion, spesolimab treatment improved outcomes in Asian patients compared with placebo, supporting its use in the treatment of GPP flares.