Ixekizumab effective in psoriatic arthritis up to 1 year regardless of methotrexate use
Ixekizumab is efficacious in patients with psoriatic arthritis for up to 1 year, with or without concomitant methotrexate use, according to data published in Arthritis Research & Therapy.
“Ixekizumab has been demonstrated to improve the signs and symptoms of PsA in patients who were biologic-naive (SPIRIT-P1) or had previous inadequate response or intolerance with TNF inhibitors (SPIRIT-P2),” Bernard Combe, MD, PhD, of CHU Montpellier, at Montpellier University, in France, and colleagues wrote. “The efficacy and safety data of IXE with and without MTX up to week 24 from SPIRIT-P1 and SPIRIT-P2 trials have been previously reported. The findings from these studies showed that IXE improved measures of disease activity and physical function when used with or without concomitant MTX therapy relative to placebo.”
To detail the extent of concomitant methotrexate treatment modification, as well as the efficacy and safety of ixekizumab (Taltz, Eli Lilly & Co.) in patients with PsA, with or without methotrexate, for up to 1 year, Combe and colleagues conducted a post hoc analysis of data from the SPIRIT-P1 and SPIRIT-P2 trials. According to the researchers, these were randomized, double-blind, placebo-controlled, phase 3 trials of patients with active PsA.
In both trials, groups of participants were randomized to 80mg ixekizumab every 4 or 2weeks, following a 160 mg initial dose. SPIRIT-P1 included patients who were biologic-naïve, whereas SPIRIT-P2 featured participants with a prior inadequate response to TNF inhibitors.
For their post hoc analysis, Combe and colleagues assessed efficacy and safety up to week 52 for the subgroups who received either ixekizumab monotherapy and combination therapy with ixekizumab and a stable dose of methotrexate. This included 177 participants treated with ixekizumab alone and 183 with stable concomitant methotrexate use for 1 year. Efficacy outcomes included the percentage of patients who achieved the American College of Rheumatology response.
According to the researchers, 66.3% of patients treated with ixekizumab monotherapy every 4 weeks achieved the ACR20 response, compared with 55.3% in the methotrexate combination therapy groups. Percentages of patients who demonstrated ACR50 and ACR70 responses at 52 weeks were 48.4% and 35.8%, respectively, for those treated with ixekizumab monotherapy every 4 weeks, compared with 38.8% and 27.1% in the concomitant methotrexate groups. Responses were generally similar among those treated with ixekizumab every 2 weeks.
In addition, safety profiles were similar between the monotherapy and combination therapy groups.
“In this post hoc analysis, IXE showed improvements in efficacy with or without concomitant MTX therapy in patients with PsA up to 52weeks of treatment,” Combe and colleagues wrote. “The safety profile is consistent with previous reports in patients with PsA and psoriasis.”
“The findings of this study increase awareness of current treatment options and inform evidence-based treatment decisions when considering concomitant MTX use when prescribing IXE for patients with PsA,” they added. “Further trial evaluating the efficacy and safety of IXE versus MTX as monotherapies and versus combination therapy in subjects with active psoriatic arthritis (PsA) could provide additional insights for clinical practice.”