Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we describe health care resource utilization (HCRU) and work productivity in RA patients from the US treated with tofacitinib.

Methods: Data for US patients enrolled in two global, Phase 3, randomized, controlled trials of 6 months’ (ORAL Step, NCT00960440) and 24 months’ (ORAL Scan, NCT00847613) duration were reviewed: these two Phase 3 trials were chosen as, for both trials, the patient populations reflected how tofacitinib is mainly prescribed in the US. Tofacitinib was dosed at 5 or 10 mg twice daily (BID) in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs) (mainly methotrexate) in patients with inadequate responses to ≥1 non-biologic or biologic DMARDs. Patients receiving placebo (in combination with DMARDs) were advanced to tofacitinib at Month 3 (ORAL Step) or by Month 6 (ORAL Scan). Analysis of endpoints for both studies occurred at Month 3, before patients receiving placebo were advanced to tofacitinib. The 17-item RA HCRU Questionnaire (v1.1) assessed the impact of RA across three domains: health care resource use, work-related activities, and daily activities. The composite Work Loss Index assessed work productivity in US patients; work productivity for the entire study population was assessed with the 25-item Work Limitations Questionnaire.

Results: Representative questions from each domain of the HCRU questionnaire are shown (Table). With the exception of doctor office visits, there was generally infrequent use of health care resources by patients receiving tofacitinib (both doses) at Month 3 in both studies, and was comparable to placebo. In ORAL Step and ORAL Scan, patients treated with both tofacitinib doses reported numerically lower impact on daily and work-related activities vs placebo at Month 3. The work productivity results reflect those of the entire study population, where US patients in ORAL Step receiving either tofacitinib 5 or 10 mg BID reported significant improvements in least squares mean (LSM) changes in work loss index from baseline vs placebo at Month 3: -1.73 (p<0.05) and -2.10 (p<0.01), respectively, vs placebo (1.36). In ORAL Scan, only US patients treated with tofacitinib 10 mg BID had significant improvements in LSM changes from baseline: -2.38 (p<0.05) vs -0.33 for placebo. Overall, the tofacitinib responses reported at Month 3 were maintained up to Month 6 (ORAL Step) and Month 24 (ORAL Scan).

Conclusion: At Month 3, US patients receiving tofacitinib in these two Phase 3 studies reported similar use of health care resources as placebo. At Month 3, patients receiving tofacitinib reported numerically less impact of RA on daily and work-related activities compared with patients receiving placebo.