Converting patient-reported outcome measures of fatigue and pain to promis scores: Data from phase 3 baricitinib rheumatoid arthritis trials

Background: Fatigue and pain in patients (pts) with RA are often measured with the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Medical Outcomes Study Short-Form-36 (SF-36). Patient-Reported Outcomes Measurement Information System (PROMIS) was developed using a populationcalibrated T-score metric (Mean 50, SD 10). Crosswalk tables were developed linking legacy instruments to PROMIS instruments, including Fatigue and Pain Interference (PI). Comparisons to the general population can be made from PROMIS scores.1-2 Objectives: To convert FACIT-F and SF-36 Bodily Pain (BP) scores to PROMIS Fatigue and PI scores to determine how PROMIS performs in 2 phase 3 baricitinib (bari) RA trials. Methods: In RA-BEAM, pts with inadequate response (IR) to MTX were randomised 3:3:2 to placebo (PBO) once daily (QD), bari-4 mg QD, or adalimumab (ADA) 40 mg biweekly.3 In RA-BEACON, pts with IR to bDMARDs were randomised 1:1:1 to receive PBO or bari 2 mg or 4 mg QD.4 FACIT-F assessed fatigue and SF-36 BP, pain. Pt-level PROMIS scores were converted from FACIT-F/SF- 36 BP using validated crosswalk tables.1-2 Analysis of covariance was conducted on PROMIS score conversions to compare bari to all treatment arms. Results: Pts had considerable baseline fatigue/pain; mean scores approached or exceeded 1 SD (10 points on the metric) from population norms. Bari was associated with clinically relevant improvements (exceeding 0.5 SD/5 points on the Tscore metric) vs PBO for PROMIS fatigue/PI scores (table 1). PROMIS fatigue/PI scores in RA-BEAM reached population norms (<55) by week 12 for bari and ADA (table 1). Bari remained associated with significant improvements in PROMIS fatigue/PI vs PBO through 24 weeks in both studies and vs ADA for PI in RABEAM (figure 1). (Figure Presented) Conclusions: While PROMIS was not used in the studies directly, pt-level crosswalk tables provide an estimate of effect that may be demonstrated when using PROMIS in clinical trials. These results provide preliminary evidence of the ability of PROMIS to demonstrate treatment benefit.