التفاصيل البيبلوغرافية
| العنوان: |
Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study. |
| المؤلفون: |
Werth, Victoria P, Fleischmann, Roy, Robern, Michael, Touma, Zahi, Tiamiyu, Iyabode, Gurtovaya, Oksana, Pechonkina, Alena, Mozaffarian, Afsaneh, Downie, Bryan, Matzkies, Franziska, Wallace, Daniel |
| المصدر: |
Rheumatology; Jun2022, Vol. 61 Issue 6, p2413-2423, 11p |
| مصطلحات موضوعية: |
THERAPEUTIC use of antineoplastic agents, DRUG efficacy, RESEARCH, LUPUS erythematosus, JANUS kinases, PROTEIN-tyrosine kinase inhibitors, RANDOMIZED controlled trials, SEVERITY of illness index, BLIND experiment, DESCRIPTIVE statistics, NEUROTRANSMITTER uptake inhibitors, STATISTICAL sampling |
| مصطلحات جغرافية: |
UNITED States, CANADA |
| مستخلص: |
Objectives To explore the safety and efficacy of filgotinib (FIL), a Janus kinase 1 inhibitor, and lanraplenib (LANRA), a spleen kinase inhibitor, in cutaneous lupus erythematosus (CLE). Methods This was a phase 2, randomized, double-blind, placebo-controlled, exploratory, proof-of-concept study of LANRA (30 mg), FIL (200 mg) or placebo (PBO) once daily for 12 weeks in patients with active CLE. At week 12, PBO patients were rerandomized 1:1 to receive LANRA or FIL for up to 36 additional weeks. Results Of 47 randomized patients, 45 were treated (PBO, n = 9; LANRA, n = 19; FIL, n = 17). The primary endpoint [change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at week 12] was not met. The least squares mean CLASI-A score change from baseline was −5.5 (s. e. 2.56) with PBO, −4.5 (1.91) with LANRA and −8.7 (1.85) with FIL. Numerical differences between FIL and PBO were greater in select subgroups. A ≥5-point improvement in the CLASI-A score at week 12 was achieved by 50.0%, 56.3% and 68.8% in the PBO, LANRA and FIL arms, respectively. A numerically greater proportion of patients in the FIL arm (50%) also achieved ≥50% improvement in the CLASI-A score at week 12 (37.5% PBO, 31.3% LANRA). Most adverse events (AEs) were mild or moderate in severity. Two serious AEs were reported with LANRA and one with FIL. Conclusion The primary endpoint was not met. Select subgroups displayed a numerically greater treatment response to FIL relative to PBO. LANRA and FIL were generally well tolerated. Trial registration ClinicalTrials.gov identifier NCT03134222 [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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