Gossec et al. demonstrated that tofacitinib significantly reduced fatigue in patients with ankylosing spondylitis, with median times to clinically meaningful improvements of 8 and 12 weeks for initial and stable improvement events, respectively. These changes were observed as early as two weeks and were more pronounced compared to placebo.

Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis

Journal Reference: Adv Rheumatol. 2024 Dec 18;64:87 doi: 10.1186/s42358-024-00402-x

Deodhar et al. conducted a pooled analysis of Phase 2 and 3 RCT data to assess the safety of tofacitinib in AS. The results showed that tofacitinib 5 mg BID had a tolerable safety profile over 48 weeks, consistent with its use in other inflammatory conditions such as RA and PsA.

May 2024

Risk of composite CV endpoints combining all ischaemic CV events and heart failure were similar for individual and combined TOF doses versus TNFi. The totality of CV risk (MACE-8 plus VTE) was higher with TOF 10mg twice daily versus TNFi. Buch et al conducted a post-hoc analysis on the ORAL Surveillance trial to assess risk across extended MACE endpoints in RA patients treated with either TOF 5mg, TOF 10mg, or TNFi.

July 2023

Kristensen, et al. used mediation modelling to show that tofacitinib indirectly improved fatigue symptoms via back pain and morning stiffness. This study was carried out using FACIT-F- and BASDAI Q1-based models to determine the relationship between these variables.

April 2023

Findings from a post hoc analysis of ORAL Surveillance can help guide individualised benefit/risk assessment and clinical decision-making on treatment with tofacitinib, based on identification of subpopulations ‘at risk’.

March 2023

Baseline 10-year atherosclerotic cardiovascular disease risk and metabolic syndrome are potentially associated with the incidence of both MACE and malignancies in patients receiving TOFA in the PsA and PsO clinical trial programs. This post hoc analysis aimed to examine the baseline CV disease risk and its association with the occurrence of MACE and malignancies in TOFA-treated patients with PsA and PsO.

February 2023

Data suggest that an important difference between P123LTE and ORAL Surveillance was the proportion of patients with a history of atherosclerotic CV disease (ASCVD).

January 2023

This post-hoc analysis of 31 clinical trials in ulcerative colitis, rheumatoid arthritis and psoriatic arthritis concludes that combined influenza adverse event incidence rates were highest in ulcerative colitis, while in each indication they were generally similar across tofacitinib, placebo, and comparator groups.

October 2022

Post hoc analysis from ORAL Surveillance observes higher major adverse cardiovascular events (MACE) risk with tofacitinib vs TNFi in patients with RA and history of atherosclerotic cardiovascular disease (ASCVD).