SAN FRANCISCO, CA—Adding methotrexate (MTX) to golimumab (GLM) therapy might significantly improve some symptoms among patients diagnosed with psoriatic arthritis (PsA), suggests a study reported at the 2015 ACR/ARHP Annual Meeting.
“[T]reatment with GLM, with or without MTX, is effective in reducing symptom severity and improving disease outcomes over a 12-month period in PsA patients,” reported lead study author Louis Bessette, MD, of the Centre d’Ostéoporose et de Rhumatologie de Québec (CORQ), in Québec, Canada. “However, concomitant treatment with MTX may confer additional benefits. Additional analyses with larger sample sizes are required.”
Earlier clinical studies indicated that concurrent MTX improves the efficacy of anti-TNF therapies, the coauthors noted. But “real-world data on the benefits of combination therapy with MTX and GLM are scarce,” they reported.
The researchers therefore compared PsA-diagnosed patients’ baseline profiles at initiation of MTX+GLM, with patients who were administered GLM monotherapy, using the Biologic Treatment Registry Across Canada (BioTRAC) database. Clinical and patient-reported outcomes were collected for each patient’s treatment baseline, 6- and 12-month marks. A total of 152 patients diagnosed with PsA were included in the analysis; patients had a mean age of 51.3 years and a mean disease duration of 4.3 years.
“The majority of patients (94.7%) in the GLM+MTX group received a high MTX dose (≥15mg/week),” the coauthors reported, and “51.8% of patients had a MTX history for the GLM group vs. 64.2% for the GLM+MTX group.”
At baseline, a higher proportion of patients in the GLM group had dactylitis (39.3% vs. 21.1%; P=0.023), they noted.
After 6 months of treatment, statistically significant and clinically meaningful improvements were seen in both groups for all disease parameters which were sustained over 12 months of treatment except PASI [Psoriasis Area and Severity Index] and HAQ-DI [Health Assessment Questionnaire–Disability Index] in the GLM group, which did not reach statistical significance.
After statistical adjustments for baseline levels, patients in the GLM+MTX group “experienced greater improvements in most disease parameters although statistical significance was achieved only for TJC [tender joint count],” the authors reported. “The proportion of patients achieving minimal disease activity (MDA) was comparable between groups with GLM (56.0%) vs. GLM+MTX (50.0%) at 6 months, and GLM (47.1%) vs. GLM+MTX (51.4%) at 12 months.”
Dr. Bessette noted further analyses with larger sample sizes are necessary.