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

Heijde, D. van der; Landewe, R.B.M.; Wollenhaupt, J.; Strengholt, S.; Terry, K.; Kwok, K.; Wang, L.; Cohen, S.

doi:doi:10.1093/rheumatology/keaa476

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 5mg twice daily (BID) or 10mg BID as monotherapy or with conventional synthetic (c)DMARDs. Radiographic outcomes up to 3 years: least squares mean (LSM) change from baseline in van der Heijde modified Total Sharp Score (Delta mTSS), erosion score (Delta ES) and joint space narrowing (Delta JSN) score; proportion of patients with no radiographic progression (Delta mTSS <= 0.5); proportion of patients with no new erosions (Delta ES <= 0.5). Delta mTSS was evaluated for up to 5 years in an exploratory analysis.Results....Show moreObjectives. 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 5mg twice daily (BID) or 10mg BID as monotherapy or with conventional synthetic (c)DMARDs. Radiographic outcomes up to 3 years: least squares mean (LSM) change from baseline in van der Heijde modified Total Sharp Score (Delta mTSS), erosion score (Delta ES) and joint space narrowing (Delta JSN) score; proportion of patients with no radiographic progression (Delta mTSS <= 0.5); proportion of patients with no new erosions (Delta ES <= 0.5). Delta mTSS 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 Delta mTSS was 1.14, LSM Delta ES was 0.66, LSM Delta JSN 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 Delta mTSS 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.Show less

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