Analysis of Disease Activity Metrics in a Methotrexate Withdrawal Study among Patients with Rheumatoid Arthritis Treated with Tofacitinib plus Methotrexate
Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00511-3
This post hoc analysis of data from the ORAL Shift study, concludes that DAS28-4(ESR), CDAI remission and SDAI remission are the metrics most likely to reflect actual disease activity, in the context of tofacitinib in a randomised withdrawal of MTX.
Infections in patients with rheumatoid arthritis receiving tofacitinib versus tumour necrosis factor inhibitors: results from the open-label, randomised controlled ORAL Surveillance trial
Post hoc analysis, using the final dataset from ORAL Surveillance, reveals a higher risk of non-serious infections and herpes zoster with tofacitinib vs TNFi, and higher risk of serious infection events with tofacitinib 10 mg BID versus TNFi, particularly in patients aged ≥65 years.
The Impact of Tofacitinib on Fatigue, Sleep, and Health‑Related Quality of Life in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of Data from Phase 3 Trials
Arthritis Res Ther. 2022;24(1):83 doi:10.1186/s13075-022-02724-x
This was an exploratory post hoc analysis of pooled data, from over 2000 patients in three Phase 3 studies of tofacitinib, which demonstrates an association between tofacitinib treatment and significantly greater improvements in fatigue, sleep, and health-related quality of life (HRQoL), compared with placebo.
Age-Based (<65 vs ≥65 years) Incidence of Infections and Serious Infections with Tofacitinib Versus Biological DMARDs in Rheumatoid Arthritis Clinical Trials and the US Corrona RA Registry
Ann Rheum Dis 2020; DOI: 10.1136/annrheumdis-2020-218992Reports from clinical trials and the US Corrona RA registry showed that serious infection event (SIE) incidence was higher in older versus younger patients with RA receiving 10 mg BID of TOF and ADA, however, SIE risk was similar between age groups with TOF 5 mg BID and ADA.Data were collected from Phase II–IV tofacitinib studies, and the US Corrona RA registry. The clinical data set evaluated patients receiving TOF 5 and 10 mg BID versus TNFi (ADA/ETN) in RA patients aged ≥50 years. The EMA rec...