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Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies

OBJECTIVES: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. We evaluated radiographic progression in tofacitinib-treated patients with RA for up to 3 years in two pooled long-term extension (LTE) studies (ORAL Sequel; A3921041) (primary analysis), and for up to 5 years using d...

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Autores principales: van der Heijde, Désirée, Landewé, Robert B M, Wollenhaupt, Jürgen, Strengholt, Sander, Terry, Ketti, Kwok, Kenneth, Wang, Lisy, Cohen, Stanley
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8023998/
https://www.ncbi.nlm.nih.gov/pubmed/33057725
http://dx.doi.org/10.1093/rheumatology/keaa476
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author van der Heijde, Désirée
Landewé, Robert B M
Wollenhaupt, Jürgen
Strengholt, Sander
Terry, Ketti
Kwok, Kenneth
Wang, Lisy
Cohen, Stanley
author_facet van der Heijde, Désirée
Landewé, Robert B M
Wollenhaupt, Jürgen
Strengholt, Sander
Terry, Ketti
Kwok, Kenneth
Wang, Lisy
Cohen, Stanley
author_sort van der Heijde, Désirée
collection PubMed
description OBJECTIVES: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. We evaluated radiographic progression in tofacitinib-treated patients with RA for up to 3 years in two pooled long-term extension (LTE) studies (ORAL Sequel; A3921041) (primary analysis), and for up to 5 years using data integrated from one phase (P)2 (A3921068), two P3 (ORAL Start; ORAL Scan) and two LTE studies (exploratory analysis). METHODS: In LTE studies, patients received tofacitinib 5 mg twice daily (BID) or 10 mg BID as monotherapy or with conventional synthetic (cs)DMARDs. Radiographic outcomes up to 3 years: least squares mean (LSM) change from baseline in van der Heijde modified Total Sharp Score (ΔmTSS), erosion score (ΔES) and joint space narrowing (ΔJSN) score; proportion of patients with no radiographic progression (ΔmTSS ≤0.5); proportion of patients with no new erosions (ΔES ≤0.5). ΔmTSS was evaluated for up to 5 years in an exploratory analysis. RESULTS: For all tofacitinib-treated patients with radiographic data available at LTE month 36 (n = 414), LSM ΔmTSS was 1.14, LSM ΔES was 0.66, LSM ΔJSN was 0.74, and 74.3% and 86.2% of patients showed no radiographic progression and no new erosions, respectively. Similar values were observed regardless of tofacitinib dose, or whether patients received tofacitinib as monotherapy or with csDMARDs. In an exploratory analysis of integrated P2/P3/LTE studies, LSM ΔmTSS was 3.34 at month 60 (n = 269). CONCLUSION: Limited progression of structural damage was observed in tofacitinib-treated patients up to 5 years, with similar results for tofacitinib used as monotherapy or combination therapy up to 3 years. TRIAL REGISTRATION: ClinicalTrials.gov (http://clinicaltrials.gov): NCT01164579; NCT01039688; NCT00847613; NCT00413699; NCT00661661.
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spelling pubmed-80239982021-04-13 Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies van der Heijde, Désirée Landewé, Robert B M Wollenhaupt, Jürgen Strengholt, Sander Terry, Ketti Kwok, Kenneth Wang, Lisy Cohen, Stanley Rheumatology (Oxford) Clinical Science OBJECTIVES: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. We evaluated radiographic progression in tofacitinib-treated patients with RA for up to 3 years in two pooled long-term extension (LTE) studies (ORAL Sequel; A3921041) (primary analysis), and for up to 5 years using data integrated from one phase (P)2 (A3921068), two P3 (ORAL Start; ORAL Scan) and two LTE studies (exploratory analysis). METHODS: In LTE studies, patients received tofacitinib 5 mg twice daily (BID) or 10 mg BID as monotherapy or with conventional synthetic (cs)DMARDs. Radiographic outcomes up to 3 years: least squares mean (LSM) change from baseline in van der Heijde modified Total Sharp Score (ΔmTSS), erosion score (ΔES) and joint space narrowing (ΔJSN) score; proportion of patients with no radiographic progression (ΔmTSS ≤0.5); proportion of patients with no new erosions (ΔES ≤0.5). ΔmTSS was evaluated for up to 5 years in an exploratory analysis. RESULTS: For all tofacitinib-treated patients with radiographic data available at LTE month 36 (n = 414), LSM ΔmTSS was 1.14, LSM ΔES was 0.66, LSM ΔJSN was 0.74, and 74.3% and 86.2% of patients showed no radiographic progression and no new erosions, respectively. Similar values were observed regardless of tofacitinib dose, or whether patients received tofacitinib as monotherapy or with csDMARDs. In an exploratory analysis of integrated P2/P3/LTE studies, LSM ΔmTSS was 3.34 at month 60 (n = 269). CONCLUSION: Limited progression of structural damage was observed in tofacitinib-treated patients up to 5 years, with similar results for tofacitinib used as monotherapy or combination therapy up to 3 years. TRIAL REGISTRATION: ClinicalTrials.gov (http://clinicaltrials.gov): NCT01164579; NCT01039688; NCT00847613; NCT00413699; NCT00661661. Oxford University Press 2020-10-15 /pmc/articles/PMC8023998/ /pubmed/33057725 http://dx.doi.org/10.1093/rheumatology/keaa476 Text en © The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Clinical Science
van der Heijde, Désirée
Landewé, Robert B M
Wollenhaupt, Jürgen
Strengholt, Sander
Terry, Ketti
Kwok, Kenneth
Wang, Lisy
Cohen, Stanley
Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies
title Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies
title_full Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies
title_fullStr Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies
title_full_unstemmed Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies
title_short Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies
title_sort assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies
topic Clinical Science
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8023998/
https://www.ncbi.nlm.nih.gov/pubmed/33057725
http://dx.doi.org/10.1093/rheumatology/keaa476
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