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A significant number of patients with psoriatic arthritis fail to achieve adequate disease control, resulting in health-related quality of life (HRQOL) impairments.
Upadacitinib was proven to provide sustained and clinically meaningful improvements in patient-reported outcomes (PROs) for patients with psoriatic arthritis (PsA) who had an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs), according to a study published in Springer.1
“Current treatment options for PsA include… bDMARDs, including tumor necrosis factor (TNF), Interleukin (IL)-12/23, IL-23, and IL-17A inhibitors,” investigators explained. “Despite the recent increase in available advanced therapies for PsA, a significant number of patients still fail to achieve adequate disease control, resulting in substantial health-related quality of life (HRQOL) impairments, which are reported in patient surveys, and highlighting a continued need for novel and effective treatment options.”
The placebo-controlled, multicenter, randomized controlled trial (RCT), phase 3 SELECT-PsA 2 (NCT03104374) study focused on patients aged 18 years or older who fulfilled the Classification Criteria for PsA (CASPAR), experienced symptoms for 6 months or longer, had a documented history of plaque psoriasis, and an inadequate response to at least 1 bDMARD. Eligible patients were then randomized 2:2:1:1 to receive oral upadacitinib 15 mg once daily (QD), upadacitinib 30 mg QD, or placebo that was then switched to either upadacitinib 15 mg QD or upadacitinib 30 mg QD at week 24 through week 56. Participants were allowed to continue treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and 2 or fewer non-bDMARDs.
At week 2, investigators compared baseline assessments of pain, Health Assessment Questionnaire- Disability Index (HAQ-DI), and Patient Global Assessment of Disease Activity (PtGA) to determine any minimum clinically important differences (MCID). They also analyzed changes from baseline and week 12 using assessments including the Functional Assessment of Chronic Illness Therapy-Fatigue, 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) score, HAQ-DI, and PtGA. The Self-Assessment of Psoriasis Symptoms (SAPS) determined differences from baseline to week 16. Other PRO assessments included SF-36 mental component summary (MCS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Work Productivity and Activity Impairment (WPAI), as well as specific questions regarding morning stiffness, itch, and pain.
In total, 641 participants received either placebo (n = 212), upadacitinib 15 mg (n = 211), or upadacitinib 30 mg (n = 218). The demographics, disease characteristics, and disease severity were similar among all patients.
Improvements in pain (15 mg: 67%, 30 mg: 69%, placebo: 50%), HAQ-DI (15 mg: 32%, 30 mg: 42%, placebo: 19%), and PtGA (15 mg: 70%, 30 mg: 72%, placebo: 52%) were seen as early as week 2 for those receiving upadacitinib when compared with the placebo cohort.
There were significant improvements from baseline at both week 12 and week 24 in the upadacitinib cohorts when compared with placebo (p <0.05) except for the WPAI survey, as it only assessed patients working outside of the home. A total of 80% of patients reported that their responses were maintained or improved through the duration of the study. At week 12, more patients in the upadacitinib cohorts had improvements ≥ MCID across all PROs, including all SF-36 domains, except for the SF-36 MCS, and the highest percentage of participants reported improvements in PtGA and pain.
Significantly more participants in the upadacitinib cohorts achieved BASDAI 50 responses when compared with placebo at both week 12 (15 mg: 20%, 30 mg: 29%, placebo: 7%) and week 24 (15 mg: 32%, 30 mg: 35%, placebo: 4%).
When patients switched from placebo to either upadacitinib 15 mg or 30 mg, PtGA, pain, HAQ-DI, and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) quickly improved and showed similar responses through week 56 as the upadacitinib cohorts.
The RCT was not designed to detect differences between the 2 upadacitinib groups and an active comparator was not used after week 24, which limits the study. Further, investigators warn that the results may not be generalizable outside of the trail participant population.
“Patients with active PsA who had failed ≥ 1 bDMARD reported significant and clinically meaningful improvements in PROs with upadacitinib 15 or 30 mg QD through 24 weeks, maintained or further improved through 56 weeks,” investigators concluded. “Significantly more patients receiving upadacitinib reported scores ≥ normative values across all evaluated PROs… These results highlight the potential for upadacitinib to provide substantial improvement in HRQOL and other important patient-reported outcomes in patients with PsA.”
Strand V, Van den Bosch F, Ranza R, et al. Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2 [published online ahead of print, 2021 Oct 18]. Rheumatol Ther. 2021;10.1007/s40744-021-00377-x. doi:10.1007/s40744-021-00377-x