Safety and efficacy of tofacitinib for the treatment of patients with juvenile idiopathic arthritis: preliminary results of an open-label, long-term extension study
ObjectivesWe report the safety, tolerability and efficacy of tofacitinib in patients with juvenile idiopathic arthritis (JIA) in an ongoing long-term extension (LTE) study.MethodsPatients (2–<18 years) with JIA who completed phase 1/3 index studies or discontinued for reasons excluding treatment-...
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Published in | Annals of the rheumatic diseases |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Language | English |
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BMJ Publishing Group Ltd and European League Against Rheumatism
07.06.2024
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Abstract | ObjectivesWe report the safety, tolerability and efficacy of tofacitinib in patients with juvenile idiopathic arthritis (JIA) in an ongoing long-term extension (LTE) study.MethodsPatients (2–<18 years) with JIA who completed phase 1/3 index studies or discontinued for reasons excluding treatment-related serious adverse events (AEs) entered the LTE study and received tofacitinib 5 mg two times per day or equivalent weight-based doses. Safety outcomes included AEs, serious AEs and AEs of special interest. Efficacy outcomes included improvement since tofacitinib initiation per the JIA-American College of Rheumatology (ACR)70/90 criteria, JIA flare rate and disease activity measured by Juvenile Arthritis Disease Activity Score (JADAS)27, with inactive disease corresponding to JADAS ≤1.0.ResultsOf 225 patients with JIA (median (range) duration of treatment, 41.6 (1–103) months), 201 (89.3%) had AEs; 34 (15.1%) had serious AEs. 10 patients developed serious infections; three had herpes zoster. Two patients newly developed uveitis. Among patients with polyarticular course JIA, JIA-ACR70/90 response rates were 60.0% (78 of 130) and 33.6% (47 of 140), respectively, at month 1, and generally improved over time. JIA flare events generally occurred in <5% of patients through to month 48. Observed mean (SE) JADAS27 was 22.0 (0.6) at baseline, 6.2 (0.7) at month 1 and 2.8 (0.5) at month 48, with inactive disease in 28.8% (36 of 125) of patients at month 1 and 46.8% (29 of 82) at month 48.ConclusionsIn this interim analysis of LTE study data in patients with JIA, safety findings were consistent with the known profile of tofacitinib, and efficacy was maintained up to month 48.Trial registration number NCT01500551. |
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AbstractList | ObjectivesWe report the safety, tolerability and efficacy of tofacitinib in patients with juvenile idiopathic arthritis (JIA) in an ongoing long-term extension (LTE) study.MethodsPatients (2–<18 years) with JIA who completed phase 1/3 index studies or discontinued for reasons excluding treatment-related serious adverse events (AEs) entered the LTE study and received tofacitinib 5 mg two times per day or equivalent weight-based doses. Safety outcomes included AEs, serious AEs and AEs of special interest. Efficacy outcomes included improvement since tofacitinib initiation per the JIA-American College of Rheumatology (ACR)70/90 criteria, JIA flare rate and disease activity measured by Juvenile Arthritis Disease Activity Score (JADAS)27, with inactive disease corresponding to JADAS ≤1.0.ResultsOf 225 patients with JIA (median (range) duration of treatment, 41.6 (1–103) months), 201 (89.3%) had AEs; 34 (15.1%) had serious AEs. 10 patients developed serious infections; three had herpes zoster. Two patients newly developed uveitis. Among patients with polyarticular course JIA, JIA-ACR70/90 response rates were 60.0% (78 of 130) and 33.6% (47 of 140), respectively, at month 1, and generally improved over time. JIA flare events generally occurred in <5% of patients through to month 48. Observed mean (SE) JADAS27 was 22.0 (0.6) at baseline, 6.2 (0.7) at month 1 and 2.8 (0.5) at month 48, with inactive disease in 28.8% (36 of 125) of patients at month 1 and 46.8% (29 of 82) at month 48.ConclusionsIn this interim analysis of LTE study data in patients with JIA, safety findings were consistent with the known profile of tofacitinib, and efficacy was maintained up to month 48.Trial registration number NCT01500551. We report the safety, tolerability and efficacy of tofacitinib in patients with juvenile idiopathic arthritis (JIA) in an ongoing long-term extension (LTE) study. Patients (2-<18 years) with JIA who completed phase 1/3 index studies or discontinued for reasons excluding treatment-related serious adverse events (AEs) entered the LTE study and received tofacitinib 5 mg two times per day or equivalent weight-based doses. Safety outcomes included AEs, serious AEs and AEs of special interest. Efficacy outcomes included improvement since tofacitinib initiation per the JIA-American College of Rheumatology (ACR)70/90 criteria, JIA flare rate and disease activity measured by Juvenile Arthritis Disease Activity Score (JADAS)27, with inactive disease corresponding to JADAS ≤1.0. Of 225 patients with JIA (median (range) duration of treatment, 41.6 (1-103) months), 201 (89.3%) had AEs; 34 (15.1%) had serious AEs. 10 patients developed serious infections; three had herpes zoster. Two patients newly developed uveitis. Among patients with polyarticular course JIA, JIA-ACR70/90 response rates were 60.0% (78 of 130) and 33.6% (47 of 140), respectively, at month 1, and generally improved over time. JIA flare events generally occurred in <5% of patients through to month 48. Observed mean (SE) JADAS27 was 22.0 (0.6) at baseline, 6.2 (0.7) at month 1 and 2.8 (0.5) at month 48, with inactive disease in 28.8% (36 of 125) of patients at month 1 and 46.8% (29 of 82) at month 48. In this interim analysis of LTE study data in patients with JIA, safety findings were consistent with the known profile of tofacitinib, and efficacy was maintained up to month 48. NCT01500551. |
Author | Bohnsack, John F Ruperto, Nicolino Schulert, Grant S Neiva, Claudia Boteanu, Alina Lucica Wouters, Ann Kasapcopur, Ozgur Kobusinska, Katarzyna Posner, Holly White, Claire Martini, Alberto Vazquez-Del Mercado, Monica Weiss, Jennifer E Lovell, Daniel J Cuttica, Ruben Wagner-Weiner, Linda Akikusa, Jonathan D Al-Abadi, Eslam Rivas-Chacon, Rafael Brunner, Hermine I Chedeville, Gaelle Wouters, Carine De La Pena, Wendy Jung, Lawrence Rizo Rodriguez, Juan Cruz Liu, Shixue Chang, Cheng Kanik, Keith |
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surname: Boteanu fullname: Boteanu, Alina Lucica organization: Rheumatology Service, Hospital Universitario Ramon y Cajal, Madrid, Spain – sequence: 6 givenname: Gaelle surname: Chedeville fullname: Chedeville, Gaelle organization: Department of Pediatrics, Division of Rheumatology, McGill University Health Centre, Glen Site, Montreal, Quebec, Canada – sequence: 7 givenname: Ruben surname: Cuttica fullname: Cuttica, Ruben organization: Paediatric Rheumatology, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina – sequence: 8 givenname: Wendy surname: De La Pena fullname: De La Pena, Wendy organization: Pediatric Rheumatology, Loma Linda University Children’s Hospital, Loma Linda, California, USA – sequence: 9 givenname: Lawrence surname: Jung fullname: Jung, Lawrence organization: Department of Pediatrics, School of Medicine, George Washington University, Washington, District of Columbia, USA – sequence: 10 givenname: Ozgur surname: Kasapcopur fullname: Kasapcopur, Ozgur organization: Department of Paediatric Rheumatology, Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey – sequence: 11 givenname: Katarzyna surname: Kobusinska fullname: Kobusinska, Katarzyna organization: Department of Paediatrics, Haematology, Oncology and Rheumatology, Wojewodzki Szpital Dzieciecy im J Brudzinskiego, Bydgoszcz, Poland – sequence: 12 givenname: Grant S orcidid: 0000-0001-5923-7051 surname: Schulert fullname: Schulert, Grant S organization: Division of Rheumatology and Department of Pediatrics, Cincinnati Children’s Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio, USA – sequence: 13 givenname: Claudia surname: Neiva fullname: Neiva, Claudia organization: Paediatric Rheumatology Network, Santa Casa de Misericórdia de Belo Horizonte, Minas Gerais, Brazil – sequence: 14 givenname: Rafael surname: Rivas-Chacon fullname: Rivas-Chacon, Rafael organization: Division of Rheumatology, Nicklaus Children's Hospital, Miami, Florida, USA – sequence: 15 givenname: Juan Cruz surname: Rizo Rodriguez fullname: Rizo Rodriguez, Juan Cruz organization: Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC, San Luis Potosí, Mexico – sequence: 16 givenname: Monica orcidid: 0000-0002-3823-4676 surname: Vazquez-Del Mercado fullname: Vazquez-Del Mercado, Monica organization: Clínica de Investigacion en Reumatologia y Obesidad, SC, Guadalajara, Mexico – sequence: 17 givenname: Linda surname: Wagner-Weiner fullname: Wagner-Weiner, Linda organization: Pediatric Rheumatology, University of Chicago Medical Center, Chicago, Illinois, USA – sequence: 18 givenname: Jennifer E surname: Weiss fullname: Weiss, Jennifer E organization: Pediatric Rheumatology, Hackensack University Medical Center, Hackensack, New Jersey, USA – sequence: 19 givenname: Carine surname: Wouters fullname: Wouters, Carine organization: Paediatric Rheumatology, Department of Paediatrics, UZ Leuven-Gasthuisberg, Leuven, Belgium – sequence: 20 givenname: Holly surname: Posner fullname: Posner, Holly organization: Pfizer, New York, New York, USA – sequence: 21 givenname: Ann surname: Wouters fullname: Wouters, Ann organization: Pfizer, New York, New York, USA – sequence: 22 givenname: Cheng surname: Chang fullname: Chang, Cheng organization: Pfizer, Groton, Connecticut, USA – sequence: 23 givenname: Claire surname: White fullname: White, Claire organization: Pfizer, Walton Oaks, UK – sequence: 24 givenname: Keith surname: Kanik fullname: Kanik, Keith organization: Pfizer, Groton, Connecticut, USA – sequence: 25 givenname: Shixue surname: Liu fullname: Liu, Shixue organization: Pfizer, Shanghai, China – sequence: 26 givenname: Alberto surname: Martini fullname: Martini, Alberto organization: Paediatric Rheumatology, Department of Paediatrics, University of Genova, Genova, Italy – sequence: 27 givenname: Daniel J orcidid: 0000-0003-1604-0130 surname: Lovell fullname: Lovell, Daniel J organization: Division of Rheumatology and Department of Pediatrics, Cincinnati Children’s Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio, USA – sequence: 28 givenname: Nicolino orcidid: 0000-0001-8407-7782 surname: Ruperto fullname: Ruperto, Nicolino organization: Pediatric and Rheumatology Clinic, IRCCS Istituto Giannina Gaslini, Genova, Italy |
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Keywords | Antirheumatic Agents Arthritis, Juvenile Therapeutics |
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Snippet | ObjectivesWe report the safety, tolerability and efficacy of tofacitinib in patients with juvenile idiopathic arthritis (JIA) in an ongoing long-term extension... We report the safety, tolerability and efficacy of tofacitinib in patients with juvenile idiopathic arthritis (JIA) in an ongoing long-term extension (LTE)... |
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SubjectTerms | Antirheumatic Agents Arthritis, Juvenile Paediatric rheumatology Therapeutics |
Title | Safety and efficacy of tofacitinib for the treatment of patients with juvenile idiopathic arthritis: preliminary results of an open-label, long-term extension study |
URI | http://dx.doi.org/10.1136/ard-2023-225094 https://www.ncbi.nlm.nih.gov/pubmed/38849152 |
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