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Early On-Treatment Change in SALT as a Pragmatic Predictor of Ritlecitinib Response in Moderate-To-Severe Alopecia
Giuseppe Gallo1,2, Isotta Giunipero di Corteranzo1, Pietro Quaglino1
1School of Dermatology and Venereology, Department of Medical Sciences, University of Turin, Turin, Italy.
Background:
Ritlecitinib, an oral covalent Janus kinase 3 (JAK3)/TEC inhibitor, is now used for alopecia areata (AA), but pragmatic early-on-treatment markers to guide continuation decisions are needed. We evaluated whether the Week-12 (W12) change in Severity of Alopecia Tool (ΔSALT) predicts Week-24 (W24) response in real-world care.
Methods:
We conducted a single-center observational cohort of consecutive patients with moderate-to-severe AA treated with ritlecitinib 50 mg once daily. Assessments occurred at baseline (V0, n = 77) and W12 (n = 55), W24 (n = 32), W36 (n = 20), W48 (n = 11), W60 (n = 7). The primary endpoint was the proportion achieving SALT ≤ 20 at W24. Secondary endpoints included SALT trajectory, clinician-reported outcomes (ClinRO) for eyebrows/eyelashes, patient-reported outcomes (HADS, Skindex-16), and safety/laboratories. Exploratorily, we tested ΔSALT V0 to W12 as a predictor of W24 response using receiver operating characteristic/area under the curve (ROC/AUC).
Results:
Median SALT declined from 90.0 (V0) to 70.0 (W12) and 30.0 (W24); intra-individual median ΔSALT vs. baseline was -10.0 at W12 and -45.0 at W24. Responders (SALT ≤ 20) were 18.2% at W12 (10/55) and 43.8% at W24 (14/32). Periocular ClinRO improved by W24 in 54.5% (eyebrows) and 36.4% (eyelashes). Patient-reported outcomes improved from W12 to W24. Safety was favorable: No serious adverse events or dose modifications were reported; adverse events were mostly mild to moderate (e.g., headache, acne, upper respiratory tract infection [URTI]/nasopharyngitis), and laboratory panels remained stable with modest lipid increases. Early ΔSALT robustly discriminated W24 outcomes: Median -41.0 in future responders vs. +3.0 in non-responders with an AUC = 0.875. ΔSALT at W12 also predicted sustained response at W48 (AUC 0.83). In multivariable analysis, ΔSALT remained independently associated with W24 response (odds ratio [OR] 1.52 per 10-point decrease).
Conclusions:
In routine practice, ritlecitinib produced rapid, clinically meaningful improvement with good tolerability. The on-treatment ΔSALT at 12 weeks is a pragmatic predictor of 24-week success and supports a treat-to-target checkpoint to inform continuation/optimization decisions alongside ClinRO and PROs.
Insights
Early changes in alopecia areata (AA) severity using the Severity of Alopecia Tool (SALT) can predict treatment success with ritlecitinib. A 12-week assessment of SALT change effectively guides continuation decisions for AA patients.
Area of Science:
- Dermatology and Immunology
- Pharmacology and Therapeutics
- Clinical Trial Analysis
Background:
- Alopecia areata (AA) treatment with ritlecitinib requires early markers to guide therapy continuation.
- Current treatment decisions lack pragmatic, on-treatment indicators for ritlecitinib efficacy in AA.
Purpose of the Study:
- To evaluate the Week-12 (W12) change in Severity of Alopecia Tool (SALT) as a predictor of Week-24 (W24) treatment response in real-world AA care.
- To assess the clinical utility of early treatment response markers for guiding ritlecitinib continuation.
Main Methods:
- Single-center observational cohort study of 77 patients with moderate-to-severe AA treated with ritlecitinib 50 mg daily.
- Analysis of Severity of Alopecia Tool (SALT) scores at baseline, W12, W24, and beyond.
- Exploratory analysis using ROC/AUC to determine the predictive value of W12 ΔSALT for W24 response.
Main Results:
- Ritlecitinib showed significant SALT score reduction by W24 (median 30.0) with 43.8% achieving SALT ≤ 20.
- Clinician-reported outcomes for eyebrows/eyelashes improved by W24 in 54.5% and 36.4% of patients, respectively.
- W12 ΔSALT robustly predicted W24 response (AUC=0.875) and sustained response at W48 (AUC=0.83), demonstrating clinical utility.
Conclusions:
- Ritlecitinib provides rapid, clinically meaningful improvements in AA with good tolerability in routine practice.
- The on-treatment ΔSALT at 12 weeks serves as a pragmatic predictor of 24-week treatment success.
- A treat-to-target approach using W12 ΔSALT, ClinRO, and PROs can inform ritlecitinib continuation/optimization decisions.
