Patient-reported Outcomes

At Week 24, significantly more patients reported “greatly” or “moderately” improved alopecia areata with LITFULO vs placebo.[1-3]

Response is based on the Patient’s Global Impression of Change (PGI-C).[1,2]*^†‡

Illustration made by Pfizer based on data in ref. 1-4

References

PGI-C is a self-administered questionnaire that asks patients to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study. Responses of “moderately” or “greatly” improved were used as the  patient-driven responder definition.

Multiple imputation methods were based on generalised linear mixed model for longitudinal binary data up to Week 24 with an assumption of "missing at random" for SALT scores missing at Week 24 due to COVID-19. Patients with missing SALT scores due to other reasons were included in the analysis as nonresponders. A single complete imputed data set for Week 24 was analysed using the Miettinen and Nurminen method.

The PGI-C response at Week 24 (key secondary endpoint for EMA) with LITFULO was statistically significant vs placebo (P<0.0001) with adjustment for multiplicity and based on a preestablished testing procedure for the EMA at an overall significance level (α=0.01).

See how LITFULO helped with eyebrow and eyelash regrowth for patients with severe alopecia areata

Eyebrow & eyelash response

EMA=European Medicines Agency; SALT=Severity of Alopecia Tool.

References:

1.LITFULO (ritlecitinib) SmPC. 2.King B, Zhang X, Harcha WG, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial. Lancet. 2023;401(10387):1518-1529. doi:10.1016/S0140-6736(23)00222-2. Erratum in: Lancet. 2023 Jun 10; 401(10392):1928. 3.King B, Zhang X, Harcha WG, et al. Supplement to: Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial. Lancet. April 13, 2023. doi:10.1016/S0140-6736(23)00222-2. 4. Thaci D. Dermatol Ther (Heidelb). 2023 Nov;13(11);2621-2634_Supplement to; Hair Loss Profiles and Ritlecitinib Efficacy in Patients with Alopecia Areata: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study.

More patients reported “greatly” or “moderately” improved alopecia areata with LITFULO vs placebo at Week 24, and continued through Week 48[1,2]

Response is based on the Patient’s Global Impression of Change (PGI-C).*^†

Graph made by Pfizer based on ref. 1 figure 1

Results after Week 24 through Week 48 were not placebo-controlled and were not adjusted for multiplicity.[2]

Illustration made by Pfizer based on data in ref. 1-4

References

Data missing due to COVID-19 were excluded, whereas patients with missing data due to other reasons were included as nonresponders.

See how LITFULO helped with eyebrow and eyelash regrowth for patients with severe alopecia areata

Eyebrow & eyelash response

References:

1.LITFULO (ritlecitinib) Summary of Product Characteristics. 2023. 2.King B, Zhang X, Harcha WG, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial. Lancet. 2023;401(10387):1518-1529. doi:10.1016/S0140-6736(23)00222-2. Erratum in: Lancet. 2023 Jun 10; 401(10392):1928. 3.King B, Zhang X, Harcha WG, et al. Supplement to: Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial. Lancet. April 13, 2023. doi:10.1016/S0140-6736(23)00222-2.4. Thaci D. Dermatol Ther (Heidelb). 2023 Nov;13(11);2621-2634_Supplement to; Hair Loss Profiles and Ritlecitinib Efficacy in Patients with Alopecia Areata: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study.