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Click here for ▼LITFULO (ritlecitinib) Prescribing Information

Overview

PGI-C

Eyebrow and Eyelash Responses

Before and After Patient images

Key secondary outcome: Proportion of patients who achieved patient-reported outcome (PGI-C) response at Week 24 vs placebo1,2,4

Significantly more patients treated with Litfulo 50mg once a day described a change from baseline alopecia areata of
“moderately improved” or “greatly improved” vs placebo as measured by PGI-C (estimated response rate 49.2% (n=62)
vs 9.2% (n=12) respectively; difference between groups was 40% [95% CI: 28.9–51.1]; p<0.000001).1,2,4

Adapted from Litfulo SPC and Pfizer Ltd. Data on File REF-LG0102. Litfulo (ritlecitinib) PGI-C Response at Week 24. 1,4

Placebo (N=131); Placebo groups from the study were combined for analysis. n=participants with PGI-C response (before imputation); N=N1+N2+N3, N=total number of participants in the full analysis set categorised under: N1= participants with non-missing PGI-C score; N2= participants with missing PGI-C score due to COVID-19 assumed to be MAR; N3= participants with missing PGI-C score due to reasons unrelated to COVID-19 considered as non-responders.

Data limitation:
Participants with missing response at Week 24 due to COVID-19, imputation was done based on predictive Bernoulli distribution with a probability equal to the probability under the MAR calculated using the sampled parameters. Participants with missing PGI-C score at Week 24 due to reasons other than COVID-19 were considered non-responders3



Extension period: Patient-reported outcome (PGI-C) to Week 48 (not placebo-controlled)3,5

An increase in the proportion of patients on Litfulo 50mg once a day with a change from baseline alopecia areata of “moderately improved” or “greatly improved” as measured by PGI-C was observed (56% [70/125]; 95% CI: 47.30-64.70; not placebo-controlled period).3,5



KEY SECONDARY OUTCOME:
Proportion of PGI-C responders with a score of "moderately improved" or "greatly improved" to Week 48 (not placebo-controlled)3N: Number of participants in the full analysis set population. n/N1(%): Number of participants with PGI-C score of ‘moderately improved’ or ‘greatly improved’ / Number of participants with valid data at the analysis visit (Non-response for missing due to reasons unrelated to COVID-19; excludes missing due to COVID-19).5

Data limitations:
Cases with missing data at that timepoint due to COVID related reasons are excluded from n and N1. Cases with missing data at Week 24 due to reasons unrelated to COVID-19 are considered as non-response5

PGI-C Evaluation >>Loading
Eyebrow and Eyelash ResponsesPGI-C defined as Patient’s Global Impression of Change. PGI-C responders were patients with a score of “moderately improved” or “greatly improved” based upon a 7-point scale of “greatly improved”, “moderately improved”, “slightly improved”, “not changed”, “slightly worsened”, “moderately worsened”, “greatly worsened” compared with study start.1,3 

CI=confidence interval; COVID=coronavirus disease; MAR=missing at random; PGI-C=Patient's Global Impression of Change.
 
  
References

1. Litfulo (ritlecitinib) Summary of Product Characteristics 
2. King B, Zhang X, Harcha WG, et al. Lancet. 2023 May 6;401(10387):1518–1529 
3. King B, Zhang X, Harcha WG, et al. Lancet. 2023. May 6;401(10387):1518–1529, supplementary appendix
4. Pfizer Ltd. Data on File REF-LGF0102. Litfulo (ritlecitnib) PGI-C Response at Week 24
5. Pfizer Ltd. Data on File: REF-LGF0043. Litfulo (ritlecitinib) PGI-C response at Week 48
  
PP-LGF-GBR-0314. August 2025

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Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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