Meaningful improvement in pain was achieved following treatment with upadacitinib and adalimumab for psoriatic arthritis (PsA), according to study results presented at the American College of Rheumatology (ACR) Convergence 2021, held November 3-10, 2021. The investigators found that improvement in pain was also associated with improvement in other key outcomes for this patient population.
In the phase 3 SELECT-PsA 1 trial (ClinicalTrials.gov Identifier: NCT03104400), patients with PsA that failed to respond to treatment with at least 1 nonbiologic disease-modifying antirheumatic drug (DMARD) were randomly assigned to receive upadacitinib 15 mg once daily (n=418), upadacitinib 30 mg once daily (n=413), adalimumab 40 mg every other week (n=420), or placebo (n=409) for 24 weeks. All participants had a baseline patient global assessment (PGA) pain score greater than 2.
Outcomes included the proportion of patients achieving meaningful pain improvement as reflected by a PGA pain score <4 and a 2-point or greater decrease from baseline through week 24. For participants in the treatment group who achieved meaningful pain improvement at weeks 4 or 24, additional outcomes included the percentage of participants who achieved minimum clinically important differences (MCID) at week 24 using the following measures: the Functional Assessment of Chronic Illness Therapy-Fatigue, the Health Assessment Questionnaire-Disability Index (HAQ-DI), the EuroQoL-5 Dimension, 5 Level (EQ-5D-5L), the 36-Item Short-Form Health Survey (SF-36), and the Work Productivity and Activity Impairment (WPAI). After adjusting for DMARD use, the investigators used Cochran-Mantel-Haenszel and chi-square tests to compare responders and nonresponders.
Compared with those receiving placebo, a significantly greater proportion of patients receiving upadacitinib 15 mg, upadacitinib 30 mg, and adalimumab reported meaningful pain improvement as early as week 2 (P <.0001). Compared with those receiving adalimumab, a significantly greater proportion of patients receiving upadacitinib 15 mg and upadacitinib 30 mg reported meaningful pain improvement starting at week 20 (P <.05) and week 4 (P ≤.01), respectively. More than 80% of patients receiving upadacitinib at either dose or adalimumab reported meaningful pain improvement to be maintained through week 24. The investigators noted the achievement of MCID in all patient-reported outcomes at week 24 in a significantly greater percentage of patients who attained meaningful pain improvement at week 24 compared with those who did not (P <.0001). Among patients who received treatment but did not attain meaningful pain improvement at week 4, a significantly greater percentage achieved MCID in the physical component summary of the HAQ-DI, EQ-5D-5L, SF-36, and WPAI activity impairment at week 24 (P <.01).
The study investigators conclude, “A greater proportion of patients achieved meaningful pain improvement with [upadacitinib and adalimumab vs placebo] throughout the 24-week treatment period… [M]eaningful pain improvement is closely linked with meaningful improvements in other important outcomes for PsA patients.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry, and some authors are employed by AbbVie Inc. Please see the original reference for a full list of authors’ disclosures.
Bessette L, Joven-Ibáñez B, Selmi C, et al. Impact of early pain improvement on patient-reported outcomes in patients with psoriatic arthritis: results from a phase 3 trial. Poster presented at: ACR Convergence 2021; November 3-10, 2021. Abstract 234.
This article originally appeared on Rheumatology Advisor