Introduction

Greater than 80% of patients with RA experience fatigue.  Fatigue, in turn, impacts sleep and is strongly associated with pain, cognition, and affective disorders.  Indeed, fatigue can be viewed as a biomarker for RA treatment efficacy.  It has been reported that treatment of RA patients with tofacitinib improves fatigue and the effect is sustained; however, the effect of tofacitinib treatment on fatigue-related symptoms, if any, is unknown.

Study Design

A post hoc analysis of pooled data from ORAL Scan, ORAL Standard, and ORAL Sync was performed.  Patients (n=2265; mean age range =  52.2-53.2 years; mean range of disease duration = 8.2-9.1 years) receiving synthetic DMARDs were further categorized as follows:  tofacitinib, 5 mg bid; tofacitinib, 10 mg bid; placebo; or adalimumab, 40 mg q2w.  The treatment effect was recorded at months 1, 3, 6, and 12, and included changes in RA disease activity (DAS28-4[ESR] and CDAI) and various standard measures of patient-reported outcomes (PROs), such as FACIT-F, MOS-SS, MOS-SS Sleep Problems Index, SF-36, PCS, and MCS.

Results and Conclusions

Treatment with tofacitinib or adalimumab resulted in improved disease activity scores and PROs as early as 1 month after treatment began, persisted for at least 6 months with nominal improvement through 12 months. Greater improvement occurred with tofacitinib than adalimumab.  

Related Research

Consider these findings from similar research studies:

• Grabovac I, Haider S, Berner C, et al. Sleep quality in patients with rheumatoid arthritis and associations with pain, disability, disease duration, and activity. J Clin Med 2018;7:336-46.

• Holdren M, Schieir O, Bartlett SJ, et al.  Improvements in fatigue lag behind disease remission in early rheumatoid arthritis:  results from the Canadian Early Arthritis Cohort.  Arthritis Rheumatol 2021;73:53-60.

• Strand V, Mysler E, Moots RJ, et al. Tofacitinib with and without methotrexate versus adalimumab with methotrexate for the treatment of rheumatoid arthritis:  patient-reported outcomes from a phase 3b/4 randomized trial.  Arthritis Rheum 2017;69:2715-6.