Smoking, PROs, and Attrition May Skew HS Study Outcomes: Commentary
Key Takeaways
A recent JAAD letter highlighted data from a long-term adalimumab study showing the need to examine smoking impact on treatment response.
The authors call for inclusion of patient-reported outcomes to better assess HS treatment efficacy.
Researchers said High attrition and limited adverse event reporting limit generalizability and safety conclusions.
A letter to the editor published in JAAD provided commentary and presented additional opportunities for further research on adalimumab and the effects of smoking on patient response while treating hidradenitis suppurativa (HS).
Data from the original Vradeli et al study supported the sustained efficacy of adalimumab in moderate-to-severe hidradenitis suppurativa (HS). Noting this, the letter authors also highlighted several methodological issues they said limited the study’s broader clinical applicability:
- The authors called for a subgroup analysis based on smoking status. While smoking data were collected in the study, the confounding effect on adalimumab response was not researched. Prior meta-analyses cited by the authors in the setting of Crohn’s disease suggested anti-TNF therapies are less effective in smokers, suggesting the possibility of similar implications in HS.
- There was an absence of robust patient-reported outcomes (PROs) such as pain intensity or functional disability. Although the original study employed the validated IHS4 clinician-rated tool, the lack of complementary PROs like DLQI, VAS, or HS-PGA limited the assessment’s multidimensionality.
- The original study reported a 72% attrition rate by week 364, but did not provide much detail on the 21 unaccounted patient dropouts.
- The authors recommend more rigorous adverse event tracking, as known risks associated with TNF inhibitors (such as tuberculosis, infections, and hypersensitivity reactions) were not systematically captured.
“We sincerely hope that with further research refinement, more robust evidence can be established regarding adalimumab’s real-world effectiveness in HS,” the authors wrote in the letter. “Addressing the critical gaps in smoking response analysis, patient-reported outcomes, and long-term safety monitoring will significantly enhance our understanding of optimal treatment strategies for this challenging condition.”
Long Q, Li Y. Source: JAAD. 2025. Doi:10.1016/j.jaad.2025.10.164