دورية أكاديمية
Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: Final Results from the BALANCE-EXTEND Open-Label Extension Study
| العنوان: | Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: Final Results from the BALANCE-EXTEND Open-Label Extension Study |
|---|---|
| المؤلفون: | Kivitz, Alan, Wells, Alvin F., Vargas, Juan I., Baraf, Herbert S. B., Rischmueller, Maureen, Klaff, Justin, Khan, Nasser, Li, Yihan, Carter, Kyle, Friedman, Alan, Durez, Patrick |
| المساهمون: | UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie |
| المصدر: | Rheumatology and Therapy, Vol. 10, no.4, p. 901-915 (2023) |
| بيانات النشر: | Springer Science and Business Media LLC |
| سنة النشر: | 2023 |
| المجموعة: | DIAL@UCL (Université catholique de Louvain) |
| مصطلحات موضوعية: | Immunology and Allergy, Rheumatology, Extension, anus kinase inhibitor, Phase 3, Rheumatoid arthritis, Treatment, Upadacitinib |
| الوصف: | Introduction: Upadacitinib (UPA) is an oral, selective Janus kinase inhibitor that has demonstrated favorable efficacy with an acceptable safety profile across a global, phase 3 program in rheumatoid arthritis (RA). This phase 2 open-label extension investigated the efficacy and safety of UPA through 6 years of treatment. Methods: Patients from two phase 2b trials (BALANCE-1 and -2) enrolled in BALANCE-EXTEND (NCT02049138) and received open-label UPA 6 mg twice daily (BID). Dose increases to 12 mg BID were required for patients with < 20% improvement in swollen or tender joint counts at weeks 6 or 12 and permitted for those not achieving Clinical Disease Activity Index (CDAI) low disease activity (LDA; CDAI 2.8 to ≤ 10). Dose reduction to UPA 6 mg BID was permitted only for safety or tolerability reasons. After January 2017, the 6/12 mg BID doses were replaced by 15/30 mg once-daily extended-release equivalents. Efficacy and safety were monitored up to 6 years of UPA treatment; outcomes included rates of achievement of LDA or remission. Data were analyzed for patients who received the lower UPA dose throughout; titrated up to the higher UPA dose from weeks 6 or 12; or titrated to the higher UPA dose and back down. Results: Overall, 493 patients entered BALANCE-EXTEND ('Never titrated', n = 306; 'Titrated up', n = 149; 'Titrated up and down', n = 38), and 223 patients (45%) completed the 6-year study. Total cumulative exposure was 1863 patient-years. Rates of LDA and remission were maintained through 6 years. Overall, 87%/70%/73% of patients in the 'Never titrated'/'Titrated up'/'Titrated up and down' groups achieved CDAI LDA at week 312, while the respective rates of Disease Activity Score 28 with C-reactive protein meeting LDA and remission criteria were 85%/69%/70% and 72%/46%/63%. Improvements in patient-reported outcomes were similar among the three groups. No new safety signals were identified. Conclusions: In this open-label extension of two phase 2 studies, UPA demonstrated sustained efficacy and an ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 2198-6576 2198-6584 |
| العلاقة: | boreal:277123; http://hdl.handle.net/2078.1/277123Test; info:pmid/; urn:ISSN:2198-6576; urn:EISSN:2198-6584 |
| DOI: | 10.1007/s40744-023-00557-x |
| الإتاحة: | https://doi.org/10.1007/s40744-023-00557-xTest http://hdl.handle.net/2078.1/277123Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.4E7A59A5 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 21986576 21986584 |
|---|---|
| DOI: | 10.1007/s40744-023-00557-x |