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Updated Integrated Safety Analysis of Ritlecitinib up to ~ 5 Years in Patients with Alopecia Areata from the ALLEGRO
Maryanne Senna1, Sameh Hanna2, Rie Ueki3
1Lahey Hospital and Medical Center, Burlington, MA, USA.
Background:
Ritlecitinib, an oral Janus kinase (JAK) 3/tyrosine kinase expressed in hepatocellular carcinoma (TEC) family kinase inhibitor, demonstrated safety in patients aged 12 years and older with alopecia areata (AA) in an initial integrated analysis of 4 clinical studies for up to 2 years.
Objective:
This updated integrated safety analysis evaluated the safety of ritlecitinib up to ~ 5 years in patients aged ≥ 12 years with AA from the ALLEGRO clinical trial program.
Methods:
Safety data were pooled from 4 studies. Two groups were analyzed: patients who received any dose of ritlecitinib (30 mg or 50 mg with or without a 4-week 200 mg loading dose, or 10 mg daily) ("any-ritlecitinib" group) and a subset of the any-ritlecitinib group including only patients who received ritlecitinib 50 mg daily with or without a 4-week 200 mg daily loading dose (ritlecitinib 50 mg ± 200-mg group). Safety data were summarized descriptively. Proportions and incidence rates (IRs; IR/100 patient-years [PYs]) of adverse events (AEs) were evaluated.
Results:
In the ritlecitinib 50-mg ± 200-mg (N = 1228) and any-ritlecitinib (N = 1294) groups, median duration of exposure was 1197 days (3261.5 PYs) and 1204 days (3539.5 PYs), respectively. AEs occurred in 1070 patients (87.1%; 148.1/100 PYs) in the 50-mg ± 200-mg group and 1158 patients (89.5%; 167.9/100 PYs) in the any-ritlecitinib group. The most common AEs included headache, positive SARS-CoV-2 test, and nasopharyngitis. Serious AEs were reported in 6.8% of patients (2.6/100 PYs) in the 50-mg ± 200-mg group and 6.8% of patients (2.5/100 PYs) in the any-ritlecitinib group. There were two deaths. Overall, 8.1% of patients (3.0/100 PYs) and 8.4% of patients (3.0/100 PYs) in the 50-mg ± 200-mg and any-ritlecitinib groups, respectively, had an AE that led to discontinuation from the study or study drug. IRs for both groups were 0.1/100 PYs for opportunistic infections, 1.0/100 PYs for herpes zoster, 0.3/100 PYs for malignancies (excluding nonmelanoma skin cancer), and 0.2/100 PYs for major adverse cardiovascular events.
Conclusions:
In this updated integrated safety analysis of the ALLEGRO clinical trials, long-term ritlecitinib treatment was generally well tolerated up to ~ 5 years in patients aged ≥ 12 years with AA. The overall safety profile was consistent with previously reported data.
Clinical Trial Registration:
NCT03732807, NCT04006457, NCT04517864, NCT02974868. Video Abstract Updated integrated safety analysis of ritlecitinib up to ~ 5 years in patients with alopecia areata from the ALLEGRO clinical trial program (MP4 407314 KB).
Insights
Long-term ritlecitinib treatment up to 5 years was safe and well-tolerated in patients aged 12 and older with alopecia areata (AA). The safety profile remained consistent with previous findings, showing good tolerability in this extended analysis.
Area of Science:
- Pharmacology and Therapeutics
- Dermatology and Immunology
- Clinical Trial Analysis
Background:
- Ritlecitinib, an oral Janus kinase (JAK) 3/tyrosine kinase expressed in hepatocellular carcinoma (TEC) family kinase inhibitor, has shown initial safety in patients aged 12+ with alopecia areata (AA).
- Previous analyses covered up to 2 years of treatment across four clinical studies.
- This study provides an updated safety assessment for longer-term exposure.
Purpose of the Study:
- To evaluate the safety and tolerability of ritlecitinib in patients aged 12 years and older with alopecia areata (AA).
- To extend the safety analysis of ritlecitinib up to approximately 5 years.
- To assess safety data from the ALLEGRO clinical trial program.
Main Methods:
- Integrated safety data from four clinical studies were pooled.
- Two patient groups were analyzed: 'any-ritlecitinib' (all doses) and 'ritlecitinib 50 mg ± 200 mg loading dose'.
- Adverse events (AEs) and incidence rates per 100 patient-years (PYs) were descriptively summarized.
Main Results:
- Median exposure reached approximately 3261.5 to 3539.5 patient-years (PYs) for the analyzed groups.
- Adverse events (AEs) were reported in 87.1% to 89.5% of patients, with headache, SARS-CoV-2, and nasopharyngitis being most common.
- Serious AEs occurred in 6.8% of patients; incidence rates for opportunistic infections, herpes zoster, malignancies, and MACE were low (≤1.0/100 PYs).
Conclusions:
- Long-term treatment with ritlecitinib up to approximately 5 years was generally well-tolerated in patients aged 12+ with alopecia areata.
- The overall safety profile observed in this extended analysis is consistent with previously reported data.
- Ritlecitinib demonstrates a favorable safety profile for long-term management of alopecia areata.
