Ritlecitinib 50 mg/day: 39.3% of 28 evaluable patients reach SALT ≤ 20 at week 48, Osaka study

A retrospective single-center observational study in Dermatology and Therapy reports 48-week outcomes of ritlecitinib at 50 mg/day in 41 patients with moderate-to-severe alopecia areata (AA), treated at Osaka Metropolitan University Hospital, Japan. At week 48, 39.3% (11/28) of evaluable patients reached a Severity of Alopecia Tool (SALT) score of 20 or lower, and 35.7% (10/28) reached 10 or lower springer.comDermatology and Therapyspringer.comOpen source ↗. AA is an autoimmune disease characterized by non-scarring hair loss.

Study design and response at week 48

According to the authors, real-world data on 48-week outcomes of ritlecitinib and on predictors of longer-term response had been limited. Effectiveness and safety were evaluated for up to 48 weeks.

Patients evaluable at week 48 were classified as responders (SALT score ≤ 20) or non-responders (SALT score > 20). The response rates above are calculated for 28 patients evaluable at week 48. The predictive value of the change in SALT score from baseline (ΔSALT) for response at week 48 was assessed using receiver operating characteristic (ROC) analysis.

Delayed response and the week-24 marker

Responders at week 48 showed greater improvement in ΔSALT at week 24 than non-responders (median: -50.0 vs. 0.0; P = 0.006) springer.comDermatology and Therapyspringer.comOpen source ↗. Of the 21 patients who had not achieved a SALT score ≤ 20 at week 24, five subsequently achieved this outcome at week 48.

ROC analysis showed that week-24 ΔSALT had predictive value for week-48 response: the area under the curve was 0.81 (95% confidence interval 0.619-1.000). A cutoff of -40 yielded 81.8% sensitivity and 88.2% specificity.

Two patients (4.9%) discontinued ritlecitinib because of adverse events. All other adverse events were mild and did not require treatment discontinuation.

The authors conclude that ritlecitinib showed real-world effectiveness through 48 weeks. They note that week-24 ΔSALT may have potential value in predicting response at week 48, and that these findings require validation in larger cohorts springer.comDermatology and Therapyspringer.comOpen source ↗.