The efficacy and safety of tofacitinib for the treatment of hidradeinitis suppurativa

Hidradenitis suppurativa (HS) is a chronic, inflammatory follicular disorder causing substantial morbidity in postpubertal individuals. This study assesses the safety and efficacy of oral tofacitinib in treating moderate to severe HS.A prospective clinical study will be conducted to enrol patients with Hurley stages II & III. Based on the history, clinical examination, and clinical pictures, the Sartorius score before and after the treatment will be obtained. The patients will be started on tofacitinib tablets at a dose of 5 mg twice a day for at least 6 months and followed up monthly for 6 more months.

The institutional ethics committee approved the study protocol.

Participants will be required to meet three inclusion criteria

1 diagnosis confirmed by European S1 guideline criteria presence of characteristic lesions in typical anatomical distributions with chronic or recurrent progression

2 refractory disease that has documented inadequate response or intolerance to upto or more than two prior systemic therapies including antibiotics, biologics, or immunosuppressants

3 availability of complete baseline data with a minimum 12 week follow up.

Key exclusion criteria comprise concurrent use of other HS targeted systemic therapies or current pregnancy or lactation status. All participants will received oral tofacitinib 5 mg twice daily with dose adjustments permitted based on clinical response.

The primary efficacy endpoint is achievement of Hidradenitis Suppurativa Clinical Response at week 12.

Secondary outcomes includes absolute changes in Sartorius score, Pain Numerical Rating Scale scores**,**Dermatology Life Quality Index scores from baseline through 36 weeks along with time to first flare following treatment discontinuation. Standardised clinical evaluations will be conducted at baseline and every four weeks thereafter supported by serial photographic documentation.

StatisticalAnalyses shall utilise paired t-tests or Wilcoxon signed-rank tests for continuous variables reported as mean plus minus standard deviation or median interquartile range, Kaplan Meier methodology for time to event analyses and logistic regression to identify predictors of treatment response

SPSS version 27.0.