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Eyebrow and Eyelash Responses
At Week 24, significantly more patients treated with Litfulo 50mg once a day achieved improvement in eyebrow regrowth versus placebo as measured by EBA response; 29% (29/100) vs 4.7% (5/107) respectively (difference between groups was 24.3% [95% CI: 14.8–34.5]; P=0.000002).1,2
Overall significance level (α) of 0.05.2
Adapted from Litfulo SPC and Data on File2
Up to Week 48 of the extension period, an increase in the proportion of patients on Litfulo 50mg once daily who achieved improvement in eyebrow regrowth as measured by EBA response was observed (43.6% (44/101); 95% CI: 33.89–53.23); not placebo-controlled period).3,4
Adapted from Data on File4
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 that timepoint due to reasons unrelated to COVID-19 are considered as non-response2, 4
N: Number of participants in the full analysis set population. n/N1(%): Number of participants with ≥ a 2-Grade improvement or a normal EBA score (percentage based on N1)/ Number of participants with abnormal EBA at baseline and valid data at the analysis visit (Non-response for missing due to reasons unrelated to COVID-19; excludes missing due to COVID-19).2, 4
Eyebrow assessment (EBA) response defined as ≥2-grade improvement from baseline or normal EBA score on a 4-point scale of 0 (none eyebrow), 1 (minimal eyebrow), 2 (moderate eyebrow), 3 (normal eyebrow) in patients with abnormal eyebrows at baseline.1,3
At Week 24, significantly more patients treated with Litfulo 50mg once a day achieved improvement in eyelash regrowth versus placebo as measured by ELA response; 28.9% (26/90) vs 5.2% (5/97) respectively (difference between groups was 23.7% [95% CI: 13.6–34.5]; P=0.000013).1,5
Overall significance level (α) of 0.05.5
Adapted from Litfulo SPC and Data on File5
Up to Week 48 of the extension period, an increase in the proportion of patients on Litfulo 50mg once daily who achieved improvement in eyelash regrowth as measured by ELA response was observed (40% (36/90) (95% CI: 29.88–50.12); not placebo-controlled period).3,6
Adapted from Data on File6
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 that timepoint due to reasons unrelated to COVID-19 are considered as non-response5,6
N: Number of participants in the full analysis set population. n/N1(%): Number of participants with ≥ a 2-Grade improvement or a normal ELA score (percentage based on N1)/ Number of participants with abnormal ELA at baseline and valid data at the analysis visit (Non-response for missing due to reasons unrelated to COVID-19; excludes missing due to COVID-19).5,6
Eyelash assessment (ELA) response defined as ≥2-grade improvement from baseline or normal ELA score on a 4-point scales of 0 (none eyelash), 1 (minimal eyelash), 2 (moderate eyelash), 3 (normal eyelash) in patients with abnormal eyelash at baseline.1,3
CI=confidence interval; COVID=coronavirus disease; ELA=eyelash assessment: EBA = eyebrow assessment: SPC = summary of product characteristics
References:
1. Litfulo (ritlecitinib) Summary of Product Characteristics
2. Pfizer Ltd. Data on File: REF-LGF0044. Litfulo (ritlecitinib) response based on at least a 2-Grade Improvement from Baseline or a Normal EBA (eyebrow assessment) score at Week 24
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-LGF0045. Litfulo (ritlecitinib) response based on at least a 2-Grade Improvement from Baseline or a Normal EBA (eyebrow assessment) score at Week 48
5. Pfizer Ltd. Data on File: REF-LGF0046. Litfulo (ritlecitinib) response based on at least a 2-Grade Improvement from Baseline or a Normal ELA (eyelash assessment) score at Week 24
6. Pfizer Ltd. Data on File: REF-LGF0047. Litfulo (ritlecitinib) response based on at least a 2-Grade Improvement from Baseline or a Normal ELA (eyelash assessment) score at Week 48
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