Pain in psoriatic arthritis (PsA) is known to be a dominant feature as well as a core disease domain. However, according to new data, patients receiving upadacitinib and adalimumab achieved meaningful pain improvements during a 24-week treatment period.

“[Pain] control is a largely unmet need, especially in patients failing non-biologic DMARDs,” wrote study authors. “The purpose of this study was to evaluate if clinically meaningful improvement in pain, particularly at earlier timepoints after treatment initiation, is associated with greater improvements in other patient reported outcomes (PROs).”

For this phase 3 trial, patients with inadequate responses to ≥1 non-biologic DMARDs were randomized to receive upadacitinib 15 mg once daily, upadacitinib 30 mg once daily, adalimumab 40 mg every other week, or placebo for 24 weeks. Researchers only evaluated patients with a baseline patient global assessment (PGA) of pain numeric rating scale (NRS) score >2.

The main outcomes of the study included “the proportion of patients achieving meaningful pain improvement (defined as achievement of a score of < 4 and ≥2-point decrease from baseline in PGA of pain NRS) through Week 24 and, for those achieving meaningful pain improvement at Weeks 4 (upadacitinib/adalimumab arms only) or 24, the percentage of patients achieving minimum clinically important differences (MCID) at Week 24 on Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), 36-Item Short-Form Health Survey (SF-36), EuroQoL-5 Dimension, 5 level (EQ-5D-5L), and Work Productivity and Activity Impairment (WPAI).”

According to the findings, there was a larger number of patients with PsA who experienced meaningful pain improvements with upadacitinib 15 mg (n=418), upadacitinib 30 mg (n=413), and adalimumab (n=420) compared with placebo (n=409) starting as early as week 2 (P< 0.0001). Furthermore, patients receiving upadacitinib 15mg experienced meaningful pain improvements at week 20, and patients receiving upadacitinib 30mg showed improvements at week 4 compared with adalimumab.

Over 80% of patients receiving both upadacitinib and adalimumab achieved pain improvments at week 4. Additionally, patients who experienced meaningful pain improvements at week 24 vs those who did not had greater proportion reported values ≥ MCID in all PROs (P< 0.0001).

Finally, the research team found that patients treated with upadacitinib and adalimumab who did vs did not attain meaningful pain improvement at Week 4, did experience a greater proportion of MCID in EQ-5D-5L, HAQ-DI, SF-36 physical component summary, and WPAI activity impairment at Week 24 (P< 0.01).

“A greater proportion of patients achieved meaningful pain improvement with [upadacitinib] and [adalimumab] vs [placebo] throughout the 24-week treatment period, and with [upadacitinib] 15 mg vs [adalimumab] by Week 20,” the study team concluded. “Meaningful pain improvement by Week 4 was associated with more patients reporting improvements ≥ MCID in several PROs at Week 24.”

“Overall, meaningful pain improvement is closely linked with meaningful improvements in other important outcomes for PsA patients.”

--Julie Gould

Reference:

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. Presented at: American College of Rheumatology Convergence 2021; November 5-9, 2021; virtual. Abstract 0234.