Evidence Supports Use of Converted PROMIS Fatigue Scores in Rheumatoid Arthritis Clinical Trials

Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scores, based on Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) items, can be used to assess fatigue and demonstrates treatment benefit in rheumatoid arthritis (RA) clinical trials, according to study results published in Arthritis Care & Research.

The 13-item FACIT-F instrument was originally developed for use in patients with cancer to assess fatigue; FACIT-F has also been validated to assess fatigue in patients with RA. However, due to the increasing importance of PROs in clinical trials, the researchers of the current study aimed to convert FACIT-F scores onto the PROMIS Fatigue metric to determine the performance of converted PROMIS Fatigue scores in 2 clinical trials of baricitinib in RA.  

A series of linking crosswalk tables and pattern-scoring were developed to convert individual, patient-level, raw 13-item FACIT-F scores to PROMIS T scores for both the 13-item FACIT-F and the 10-item RA-optimized FACIT-F instrument, in RA-BEAM and RA-BEACON (ClinicalTrials.gov Identifiers: NCT01710358 and NCT01721044, respectively), the clinical trials to evaluate baricitinib treatment for patients with RA with an inadequate response to methotrexate.

At baseline, the average converted PROMIS Fatigue scores in across treatment groups in both trials reflected severe fatigue, which improved significantly with baricitinib 4 mg compared with placebo, as measured by the FACIT-F. Improvement in fatigue was maintained for PROMIS Fatigue scores.

Irrespective of the score conversion method used, PROMIS Fatigue measures yielded similar patterns in terms of the amount of fatigue and change over time, which were similar to earlier reports from the baricitinib clinical trials using FACIT-F.

Regarding study limitations, the researchers noted that additional clinical and observational trials and the performance of PROMIS Fatigue measures in patients with RA with lower levels of baseline fatigue were warranted.

“Our results suggest that the measurement of fatigue using the PROMIS T score metric can be used as an outcome demonstrating treatment benefit in RA clinical trials,” the researchers concluded.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Bingham CO III, Bartlett SJ, Kannowski C, Sun L, DeLozier AM, Cella D. Conversion of functional assessment of chronic illness therapy-fatigue to patient-reported outcomes measurement information system fatigue scores in two phase III baricitinib rheumatoid arthritis trials. Arthritis Care Res (Hoboken). 2021;73(4):481-488. doi:10.1002/acr.24144