PsA Treatment Deemed Safe, Effective

Treatment with ixekizumab (IXE) every 2 (IXEQ2W) or 4 weeks (IXEQ4W) is safe and effective for patients with psoriatic arthritis (PsA), according to a recent study.

In the SPIRIT-P1 study, the researchers evaluated 417 patients with PsA. Patients were first randomly assigned to treatment with 80 mg IXEQ2W or IXEQ4W following a 160-mg starting dose, placebo, or 40 mg adalimumab (ADA) every 2 weeks.
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At week 24, or at week 16 for those who demonstrated inadequate response, patients treated with ADA (after an 8-week washout prior to initiating IXE) or placebo were randomly assigned to treatment with IXEQ2W or IXEQ4W. Treatment groups during the extension period (weeks 24 to 52) included IXEQ2W/IXEQ2W, IXEQ4W/IXEQ4W, ADA/IXEQ2W, ADA/IXEQ4W, placebo/IXEQ2W, and placebo/IXEQ4W.

A total of 381 (91.4%) patients entered the extension period. Results showed that American College of Rheumatology (ACR)20 (69.1% and 68.8%), ACR50 (54.6% and 53.1%), and ACR70 (39.2% and 39.6%) response rates were sustained at week 52 among patients in the IXEQ4W/IXEQ4W and IXEQ2W/IXEQ2W groups. Treatment effectiveness was also sustained at week 52 among patients who were randomly assigned again to IXE during the extension period.

The researchers observed a similar pattern for Psoriasis Area and Severity Index outcomes. Minimal radiographic progression was noted in all treatment groups.

Nasopharyngitis, injection site reaction, injection site erythema, upper respiratory tract infection, and back pain were the most commonly reported treatment-emergent adverse events (4% or less).

“During the extension period, IXEQ4W or IXEQ2W treatment demonstrated sustained efficacy in key PsA domains with a safety profile consistent with other studies investigating IXE,” the researchers concluded.

—Christina Vogt

Reference:

van der Heijde D, Gladman DD, Kishimoto M, et al. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis: 52-week results from a phase III study (SPIRIT-P1). J Rheumatol. 2018;45(3):367-377. https://doi.org/10.3899/jrheum.170429.