LITFULO (ritelicitinib) | Hårrespons i hodebunnen

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Alopecia Areata

LITFULO virkningsmekanisme

SALT Evaluering

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Hårrespons i hodebunnen

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Hårrespons i hodebunnen

SALT ≤10 at
Week 24

SALT ≤10
Through Week 48

SALT ≤20 at
Week 24

At Week 24, significantly more patients achieved near-complete to complete (SALT ≤10) scalp hair regrowth with LITFULO vs placebo (P=0.0003)^1,2

Patients who achieved 90% or more scalp hair coverage at Week 24*^†

References

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 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. Vertical bars represent 95% CIs.

The proportion of patients who achieved SALT ≤10 at Week 24 (primary endpoint for the EMA) with LITFULO was statistically significant vs placebo (P=0.0003) with adjustment for multiplicity and based on preestablished testing procedures for the EMA at an overall significance level (α=0.01).

What is SALT?

The Severity of Alopecia Tool (SALT) helps visually assess the extent of scalp hair loss.^3,4

The SALT score equals the sum of the proportions of scalp hair loss per quadrant³

The SALT score measures hair loss on a scale of 0 (no scalp hair loss) to 100 (complete scalp hair loss). For example, SALT 10 can be defined as 10% scalp hair loss and/or 80% scalp hair coverage^1,3

Explore patient-reported outcomes

Pasientrapporterte utfall

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

References:

By Week 48, LITFULO helped 31% of patients achieve near-complete to complete (SALT ≤10) scalp hair regrowth^1‐3

Patients who achieved 90% or more scalp hair coverage through Week 48*

References

Results after Week 24 through Week 48 were not placebo-controlled and were not adjusted for multiplicity.^2,3

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

What is SALT?

The Severity of Alopecia Tool (SALT) helps visually assess the extent of scalp hair loss.^3,4

The SALT score equals the sum of the proportions of scalp hair loss per quadrant³

Explore patient-reported outcomes

Pasientrapporterte utfall

SALT=Severity of Alopecia Tool.

References:

1. LITFULO (ritlecitinib) Summary of Product Characteristics. 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

At Week 24, significantly more patients achieved near-complete (SALT ≤20) scalp hair regrowth with LITFULO vs placebo^1,2

Patients who achieved 80% or more scalp hair coverage at Week 24*^†

References

The Miettinen and Nurminen method was used to calculate 95% CIs and the Farrington-Manning method was used to calculate P values for testing the difference in the proportion of response between each active treatment group and placebo. Data missing due to COVID-19 were excluded from this analysis, whereas patients with missing data due to other reasons were included in the analysis as nonresponders.

The proportion of patients who achieved SALT ≤20 at Week 24 (the primary endpoint for all clinical study [α=0.05] and for the FDA [α=0.00125]) with LITFULO was statistically significant vs placebo (P<0.00001).

Explore patient-reported outcomes

Pasientrapporterte utfall

CI=confidence interval; SALT=Severity of Alopecia Tool.

References:

tab 4

SALT ≤20
Through Week 48

By Week 48, LITFULO helped 43% of patients achieve near‐complete (SALT ≤20) scalp hair regrowth^1‐3

Patients who achieved 80% or more scalp hair coverage through Week 48*

References

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

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

Explore patient-reported outcomes

Patsientrapporterte utfall

SALT=Severity of Alopecia Tool.

References:

Post hoc
Analysis

With continued use, LITFULO helped patients sustain scalp hair regrowth at Week 24 through Week 48¹

A post hoc analysis evaluated the percent of patients treated with LITFULO (n=130) who achieved SALT ≤20 or SALT ≤10 at Week 24 and who sustained that response between Week 24 and Week 48. This post hoc analysis evaluated their responses between Week 24 through Week 48.*^†

References

Descriptive analyses were used to evaluate the proportion of patients treated with LITFULO 50 mg who achieved SALT ≤10 or SALT ≤20 at Week 24, and sustained the SALT response through Week 48. Response was defined as SALT ≤10 or SALT ≤20 at all time points between Week 24 and Week 48 (Weeks 28, 34, or 40).

Patients with missing SALT score data at Weeks 28, 34, or 40 were included in the analysis if they had observed SALT data at Week 24 and Week 48; patients with missing data at Week 48 were excluded from the analysis.

Data Limitations

Sustained response at any time point between Weeks 24 to 48, among patients who achieved SALT ≤20 or SALT ≤10 at Week 24, was a post hoc analysis that was not controlled for multiplicity, and was descriptive in nature with no formal testing of the hypothesis. Therefore, no conclusions regarding treatment differences should be made as results could represent chance findings.

Post Hoc Analysis Method¹

This post hoc analysis evaluated sustained response in patients treated with ritlecitinib who achieved target response criteria at Week 24. Patients were categorised as either achieving or not achieving the following target response criteria at Week 24: SALT score of ≤20 and SALT score of ≤10. Patients could be classified as a responder for ≥1 of the categories and were not required to achieve all criteria.

The proportions of ritlecitinib-treated patients with target clinical response at Week 24, and who sustained this response through Week 48, were assessed by treatment group. For each endpoint, sustained response required response at Weeks 24 and 48, and no loss of response at any time point between Weeks 24 and 48. Patients with missing SALT scores at intermediate visits were included in the analysis if they had observed data at Weeks 24 and 48. Safety was monitored throughout the study. Data were reported up to Week 48 by Week 24 response status.

Explore patient-reported outcomes

Pasientrapporterte utfall

SALT=Severity of Alopecia Tool.

References:

1. Piliang, M., Lynde, C., King, B., Mirmirani, P. , Sinclair, R., Wolk, R. , Zwillich, S. , Tran , H., Zhang, F. and Takiya, L. 2023. Sustained hair regrowth with ritlecitinib to Week 48 in patients with alopecia areata: post hoc analysis of the ALLEGRO phase 2b/3 study. SKIN The Journal of Cutaneous Medicine. 7, 2 (Mar. 2023), s188

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PP-BCP-NOR-0001 juni 2023

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