Use of the Patient Reported Outcomes Measurement Information System (PROMIS) may be beneficial for the evaluation of physical and mental health in individuals with active rheumatoid arthritis (RA), with improved measures following the initiation of disease-modifying antirheumatic drug (DMARD) therapy, according to the results of an ongoing prospective observational study published in Arthritis Care & Research.
A total of 156 participants were evaluated prior to starting a new DMARD and then at 12 to 24 weeks after taking their first dose of the medication. Overall, 82.1% of the patients were women, mean age was 54.6±13.6 years, and mean disease duration was 10.0±12.6 years. All participants completed the PROMIS Global Health v1.1 (Mental Global Health and Physical Global Health) and the PROMIS pain intensity 3a short forms at the baseline and follow-up visits. In addition, they completed the following PROMIS physical and mental health domains, which were evaluated using computerized adaptive tests: pain interference, pain behavior, sleep disturbance, sleep-related impairment, fatigue, anxiety, and depression.
At baseline, 60.9% of participants were taking ≥1 DMARD, with 44% receiving nonbiologic DMARDs and 26.3% receiving biologic DMARDs. Linear regression models identified cross-sectional associations between baseline PROMIS measures and changes in disease activity using the Clinical Disease Activity Index (CDAI). Mean baseline CDAI was 25.5±14.0 in all the study participants. Baseline scores for PROMIS measures of physical health, sleep, and pain were all significantly associated with baseline CDAI (P ≤.05).
In the 106 participants with 12-week data, all PROMIS measures demonstrated significant improvement following DMARD initiation (P ≤.05). With the exception of the depression domain, changes in all PROMIS scores were associated with changes in CDAI. Moreover, the swollen joint component of the CDAI was significantly associated only with the PROMIS sleep disturbance domain (P <.05). Increases in CDAI or in the individual CDAI components were associated with worsening PROMIS scores.
The investigators noted that additional research is warranted in order to determine the minimal clinically important changes in PROMIS scores in individuals with RA and to further elucidate the effects of baseline RA disease activity on the responsiveness of these measures.
Disclosures: Dr Lee reports a research grant from Pfizer and stock in Express Scripts. Dr Bolster reports receiving research funding from Amgen and Eli Lilly.
Wohlfahrt A, Bingham CO III, Marder W, et al. Responsiveness of patient reported outcomes measurement information system (PROMIS) measures in RA patients starting or switching a DMARD [published online June 8, 2018]. Arthritis Care Res (Hoboken). doi:10.1002/acr.23617