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

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Title: Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies.
Authors: Heijde, Désirée van der, Landewé, Robert B M, Wollenhaupt, Jürgen, Strengholt, Sander, Terry, Ketti, Kwok, Kenneth, Wang, Lisy, Cohen, Stanley
Source: Rheumatology; Apr2021, Vol. 60 Issue 4, p1708-1716, 9p
Subject Terms: DISEASE progression, COMBINATION drug therapy, JANUS kinases, ANTIRHEUMATIC agents, RHEUMATOID arthritis, DESCRIPTIVE statistics, QUESTIONNAIRES, NEUROTRANSMITTER uptake inhibitors
Abstract: 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. [ABSTRACT FROM AUTHOR]
Copyright of Rheumatology is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies.
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  Data: <searchLink fieldCode="AR" term="%22Heijde%2C+Désirée+van+der%22">Heijde, Désirée van der</searchLink><br /><searchLink fieldCode="AR" term="%22Landewé%2C+Robert+B+M%22">Landewé, Robert B M</searchLink><br /><searchLink fieldCode="AR" term="%22Wollenhaupt%2C+Jürgen%22">Wollenhaupt, Jürgen</searchLink><br /><searchLink fieldCode="AR" term="%22Strengholt%2C+Sander%22">Strengholt, Sander</searchLink><br /><searchLink fieldCode="AR" term="%22Terry%2C+Ketti%22">Terry, Ketti</searchLink><br /><searchLink fieldCode="AR" term="%22Kwok%2C+Kenneth%22">Kwok, Kenneth</searchLink><br /><searchLink fieldCode="AR" term="%22Wang%2C+Lisy%22">Wang, Lisy</searchLink><br /><searchLink fieldCode="AR" term="%22Cohen%2C+Stanley%22">Cohen, Stanley</searchLink>
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  Data: Rheumatology; Apr2021, Vol. 60 Issue 4, p1708-1716, 9p
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  Data: <searchLink fieldCode="DE" term="%22DISEASE+progression%22">DISEASE progression</searchLink><br /><searchLink fieldCode="DE" term="%22COMBINATION+drug+therapy%22">COMBINATION drug therapy</searchLink><br /><searchLink fieldCode="DE" term="%22JANUS+kinases%22">JANUS kinases</searchLink><br /><searchLink fieldCode="DE" term="%22ANTIRHEUMATIC+agents%22">ANTIRHEUMATIC agents</searchLink><br /><searchLink fieldCode="DE" term="%22RHEUMATOID+arthritis%22">RHEUMATOID arthritis</searchLink><br /><searchLink fieldCode="DE" term="%22DESCRIPTIVE+statistics%22">DESCRIPTIVE statistics</searchLink><br /><searchLink fieldCode="DE" term="%22QUESTIONNAIRES%22">QUESTIONNAIRES</searchLink><br /><searchLink fieldCode="DE" term="%22NEUROTRANSMITTER+uptake+inhibitors%22">NEUROTRANSMITTER uptake inhibitors</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: 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. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label:
  Group: Ab
  Data: <i>Copyright of Rheumatology is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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      – Type: doi
        Value: 10.1093/rheumatology/keaa476
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      – Code: eng
        Text: English
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        PageCount: 9
        StartPage: 1708
    Subjects:
      – SubjectFull: DISEASE progression
        Type: general
      – SubjectFull: COMBINATION drug therapy
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      – SubjectFull: JANUS kinases
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      – SubjectFull: ANTIRHEUMATIC agents
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      – SubjectFull: RHEUMATOID arthritis
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      – SubjectFull: DESCRIPTIVE statistics
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      – SubjectFull: QUESTIONNAIRES
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      – SubjectFull: NEUROTRANSMITTER uptake inhibitors
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    Titles:
      – TitleFull: Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies.
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            NameFull: Heijde, Désirée van der
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              Text: Apr2021
              Type: published
              Y: 2021
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