In the treatment of rheumatic and musculoskeletal diseases (RMDs), there is a need for feasible measures of patient-reported bother (impact on life and cumulative burden) from side effects and the benefit-harm-balance. Berthelsen et al. evaluated what with RMDs considered important to know about symptomatic side effects they may experience from a new prescription drug.

May 2022

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.

Study shows that conversions from FACIT-F to PROMIS Fatigue are feasible and applicable for RA clinical trials.The Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), developed for use in cancer patients, has been validated for measuring fatigue in RA, and is often the tool used in European clinical trials; with 10 out of its 13 items being relevant for patients with RA. The Patient-Reported Outcomes Measurement Information System (PROMIS), developed and calibrated in the United ...