An exploratory post hoc analysis of data from Phase 3 trials depicted that compared to placebo, tofacitinib and adalimumab were related to better improvement in health-related quality of life (HRQoL), sleep, and fatigue through the 6th month with improvements maintained to the 12th month in people diagnosed with active rheumatoid arthritis (RA). 

Susan J Bartlett et al. aimed to determine influence of tofacitinib given in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) on patient-reported outcomes (PROs) concerning HRQoL, sleep, and fatigue. The link between fatigue, PROs, and disease activity in RA patients was also investigated. Notably, the data was pooled from 3 tofacitinib studies in people with RA. Participants were given 5 or 10 mg of tofacitinib two times a day, placebo, or adalimumab with csDMARDs. 

The following parameters were evaluated through month 12: percentage of people experiencing betterment from the baseline in functional assessment of chronic illness therapy-fatigue (FACIT-F) total and short form-36 (SF-36) domain scores ≥ minimum clinically important differences (MCIDs) or ≥ population normative values, SF-36 health survey composite/domain scores, medical outcomes study sleep scale (MOS-SS), FACIT-F, and changes from baseline in disease activity.

At month 6, associations among PROs were analyzed by Pearson correlations. In the first month, active treatment resulted in substantial betterment from the baseline in FACIT-F total, and MOS-SS and SF-36 composite/domain scores when compared to placebo. These improvements were reported to be maintained through the sixth month. Through the sixth month, more number of people reported improvements from the baseline ≥ MCID and attained scores ≥ population normative values in the FACIT-F total and the SF-36 domain scores with the tofacitinib versus placebo.

Some minimally important enhancements with tofacitinib versus adalimumab were seen through month 12. FACIT-F scores were highly associated with the MOS-SS sleep problems index I score, moderately corresponding with most MOS-SS domain scores, and moderately (0.40-0.59) to largely (≥ 0.60) linked with the SF-36 composite/domain scores. The disease activity correlations were found to be low to moderate with SF-36 general health domain/composite scores, and moderate with FACIT-F scores.

Associations observed at month 6 between fatigue, PROs of sleep, HRQoL, and disease activity highlighted the congruity of HRQoL and fatigue with multiple aspects of social, emotional, and physical health.