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In this 48-week, phase 3, randomized controlled trial, investigators examined patient-reported outcomes of patients with psoriatic arthritis receiving methotrexate monotherapy, etanercept monotherapy, or a combination of both drugs.
In order to improve quality of life for patients with psoriatic arthritis (PsA), investigators examined the effectiveness of etanercept (a tumor necrosis factor inhibitor) monotherapy, methotrexate (MTX) monotherapy, and combination therapy. The study, published in The BMJ,1 showed that etanercept monotherapy and combination therapy were more successful at treating PsA symptoms and improving patient-reported outcomes (PROs) compared with MTX alone.
Patients with PsA often report peripheral and axial joint inflammation, enthesis inflammation, nail disease and psoriasis. These symptoms negatively affect PROs and are “associated with considerable disease burden including bodily pain and physical function below that of age-matched and gender-matched norms, fatigue, increased absenteeism from work, and decreased work productivity.” It is crucial that rheumatologists treating patients with PsA work quickly to create effective treatment plans in order to improve quality of life and maximize therapeutic results.
In this 48-week, phase 3, randomized controlled trial (NCT02376790), investigators examined PROs of patients with PsA receiving MTX monotherapy, etanercept monotherapy, or a combination of both drugs. Patients were ≥ 18 years old with active PsA, naïve to etanercept, and had no prior MTX use. The study was conducted at 124 hospitals/centers/clinics in 17 countries. A total of 851 patients participated in the study, with a mean (SD) age of 48.4 (13.1) years and 90.7% were Caucasian. Eligible patients were randomized 1:1:1 and received either MTX (target 20 mg/week) along with a placebo, etanercept (50 mg/week) along with a placebo, or etanercept (50 mg/week) plus MTX (target 20 mg/week). PROs were evaluated every 12 weeks.
The PROs evaluated HRQoL, physical function, and global assessments of disease activity, which included HAQ-DI, Patient Global Assessment of disease activity (PtGA), Patient Global Assessment of Joint Pain (PtGAJP), and Medical Outcomes Study Short Form-36 Questionnaire (SF-36) summary and domain scores. Investigators assessed these scores at week 24 and compared them to age-matched and gender-matched normative values to ascertain improvements in PROs. These scores were prioritized because “assessments are affected by treatment efficacy, safety, tolerability, dosing frequency, and route of administration.” No deaths occurred during the study and incidence rates for both adverse events and serious adverse events were similar across all 3 groups.
At week 24, all 3 treatment groups had improvements in PRO scores, however patients receiving etanercept monotherapy and combination therapy had greater success when compared with MTX monotherapy in PtGA, PtGAJP, SF-36 PCS, and Bodily Pain domain. Both the etanercept monotherapy and combination groups reported significant changes in PtGA scores by week 24: 78.3% with etanercept monotherapy, 75.1% with combination therapy, and only 66.7% with MTX alone. At week 24, 20.8% to 51% of patients receiving MTX monotherapy, 30.9% to 48.8% of those receiving etanercept monotherapy, and 30.6% to 52.3% receiving the MTX and etanercept combination therapy met or exceeded age and gender-matched normative values.
The study was limited by the lack of a placebo group, however investigators believe that there would be “ethical issues regarding prolonged placebo exposure in patients with active, especially early disease.” Another limitation faced was the generalizability of the results, as the results of the treatment-naïve population may differ from those with severe or moderate PsA. In the future, “PsA should include active comparators and PROs in their design. In addition, direct comparisons between different treatments could help determine which treatments are more effective in patients with PsA,” Investigators concluded. “Considering results from this [randomized controlled trial], PROs should be incorporated in discussions between patients and clinicians regarding their choice of treatment, to incorporate the patient’s perspective.”
Strand V, Mease PJ, Maksabedian Hernandez EJ, et al. Patient-reported outcomes data in patients with psoriatic arthritis from a randomised trial of etanercept and methotrexate as monotherapy or in combination. RMD Open. 2021;7(1):e001484. doi:10.1136/rmdopen-2020-001484