Effect of Certolizumab Pegol on Multiple Facets of Psoriatic Arthritis as Reported by Patients: 24‐Week Patient‐Reported Outcome Results of a Phase III, Multicenter Study

Abstract

ObjectiveTo examine the effect of certolizumab pegol (CZP) on patient-reported outcomes (PROs) in psoriatic arthritis (PsA) patients with and without prior tumor necrosis factor (TNF) inhibitor exposure.MethodsThe ongoing phase III RAPID-PsA trial was double blind and placebo controlled to week 24. Patients were randomized 1:1:1 to placebo every 2 weeks or CZP 400 mg at weeks 0, 2, and 4, followed by either CZP 200 mg every 2 weeks or CZP 400 mg every 4 weeks. PRO measures evaluated were the Health Assessment Questionnaire (HAQ) disability index (DI), health status (measured by the Short Form 36 [SF-36] health survey), Psoriatic Arthritis Quality of Life (PsAQOL), Fatigue Assessment Scale, patient assessment of pain (visual analog scale), and Dermatology Life Quality Index (DLQI). Post hoc analyses of PROs in patients with and without prior TNF inhibitor exposure were conducted. Change from baseline for all PROs was analyzed for the randomized population using analysis of covariance with last observation carried forward imputation.ResultsA total of 409 patients were randomized. Twenty percent had received a prior TNF inhibitor. Baseline demographics were similar between the treatment groups. At week 24, clinically meaningful differences in HAQ DI, SF-36, PsAQOL, fatigue, pain, and DLQI were observed in both CZP arms versus placebo (P < 0.001), irrespective of prior TNF inhibitor exposure. More CZP-treated patients reached SF-36 general population norms than placebo-treated patients.ConclusionBoth CZP dosing schedules provided rapid improvements in PROs across multiple disease aspects in patients with PsA. The benefits of CZP treatment for health-related quality of life were seen across generic, PsA-specific, and dermatology-specific measures and were observed in patients regardless of prior TNF inhibitor exposure.

Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

“…The results of the current study appear consistent with previous results of bDMARD interventions in patients with RA, PsA or AS, with TNFi therapy shown to improve patient-reported pain in patients with RA (with an inadequate response to csDMARDs),17 PsA18–20 or AS 21. In patients with RA, other therapies such as abatacept, anakinra and the interleukin-6 inhibitor tocilizumab have also improved patient-reported pain 17.…”

Efficacy of pharmacological interventions: a systematic review informing the 2023 EULAR recommendations for the management of fatigue in people with inflammatory rheumatic and musculoskeletal diseases

“…This SR shows strong evidence that pharmacological interventions, especially biologics, are efficacious in reducing fatigue in people with I-RMDs, suggesting that control of inflammatory disease activity coadjuvates the reduction of fatigue levels. This trend was observed after evaluating several specific I-RMDs, namely RA (n=49), 42–91 SpA (excluding PsA) (n=13), 92–104 SjS (n=15), 105–119 PsA (n=10), 120–129 SLE (n=8), 130–137 SSc (n=1), 138 IIM (n=1) 139 and GCA (n=1). 140 …”

“…Study characteristics are detailed in online supplemental file 3 . Pharmacological interventions where fatigue was included as an outcome were tested in the following I-RMD among the 99 RCTs: RA (n=50), 42–91 SpA (excluding PsA) (n=13), 92–104 SjS (n=15), 105–119 PsA (n=10), 120–129 SLE (n=8), 130–137 SSc (n=1), 138 IIM (n=1) 139 and GCA (n=1). 140 …”

International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials

“…In total, 50 patients (50%) and 75 physicians (60%) completed the survey. Patient respondents were 64% female and age groups (years) 2% (18)(19)(20)(21)(22)(23)(24)(25), 36% (26-45), 52% (46-65) and 10% above 65. Physician respondents were 92% rheumatologists and 8% dermatologists, 61% male, and age groups (years) 33% (26-45), 60% (46-65) and 7% (above 65).…”