MADRID — Tildrakizumab demonstrated efficacy in treating psoriatic arthritis in joints and skin, with a low rate of treatment-emergent adverse events, according to the results of a study presented at the 2019 European League Against Rheumatism (EULAR) Congress, held June 12-15, in Madrid, Spain.
This phase 2b, double-blind study (ClinicalTrials.gov identifier: NCT02980692) included 391 participants with at least 6 months of psoriatic arthritis symptoms, all of whom had 3 tender and 3 swollen joints. The participants were randomly assigned to one of the following 5 treatment regimens: 1:1:1:1:1 of tildrakizumab 200 mg once monthly (Q4W)(n=78); 200 mg every 12 weeks (Q12W) (n=79); 100 mg Q12W (n=77); 20 mg Q12W up to week 24 (n=78); and placebo Q4W up to week 24 (n=79).
The primary end point of the study was to determine the proportion of participants who achieved a 20% decrease in American College of Rheumatology response criteria (ACR20) between baseline and week 24. The secondary end points were to determine the proportion of participants who achieved a 75% reduction in the Psoriasis Area and Severity Index (PASI 75) and ACR50/70; the proportion who received PASI 90; and the number of tender/swollen joints at week 24. Treatment-emergent adverse events were monitored as part of the safety assessments.
At week 24, participants who received tildrakizumab had achieved ACR20/50/70 and PASI 75/90 significantly more often than those on placebo. Week 8 was the earliest time point when such differences became evident. The most common treatment-emergent adverse events were diarrhea (tildrakizumab, 1.3%; placebo, 0%) and nasopharyngitis (tildrakizumab, 5.4%; placebo: 6.3%).
There were no deaths, and none of the participants discontinued treatment because of adverse events. Acute treatment-emergent adverse events were similar among tildrakizumab and placebo (2.2% vs 2.5%, respectively).
The study researchers concluded that “[by] week 24, [tildrakizumab] was significantly more efficacious than [placebo] in treatment of joint and skin manifestations of [psoriatic arthritis].
Furthermore, there was a clear separation between [tildrakizumab] and [placebo] as early as 8 weeks for ACR20 ([tildrakizumab] 200 mg Q4W and 100 mg) and 12 weeks for ACR50 (all [tildrakizumab] groups). Shortening the dosing interval from Q12W to Q4W for the 200-mg dose did not result in a measurable increase in skin or joint response scores. There was a low rate of [treatment-emergent adverse events] in the [tildrakizumab]-treated group.”
Philip J. Mease, MD, MACR, director of rheumatology research at the Swedish Medical Center/Providence St Joseph Health, said “as a researcher and clinician, it’s encouraging to see these improvements in pain, joint swelling and skin plaques. Our interim findings showed that about half of the patients treated with 100 mg or 200 mg of tildrakizumab saw a 50 percent improvement in psoriatic arthritis symptoms and about a quarter saw a 70 percent improvement within 24 weeks” in a press release.
Disclosure: Funding for the study was provided by Sun Pharmaceutical Industries, Inc. Several authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.
Mease PJ, Chohan S, García Fructuoso FJ, et al. Randomised, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of tildrakizumab, a high-affinity anti-interleukin-23P19 monoclonal antibody, in patients with active psoriatic arthritis. Presented at: European League Against Rheumatism (EULAR) Congress 2019; June 12-15, 2019; Madrid, Spain. Abstract LB0002.