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Tildrakizumab yields encouraging efficacy, safety outcomes in PsA
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Tildrakizumab was associated with strong PASI90 and ACR20 results compared with placebo in a cohort of patients with psoriatic arthritis, according to recent findings presented at the EULAR Annual Congress.
“Our results demonstrate a clear separation between tildrakizumab (Ilumya, Sun Pharma) and placebo as early as 8 weeks,” Philip Mease, MD, MACR, of Swedish Medical Center/Providence St. Joseph Health and the University of Washington in Seattle, said in a press release.
Mease and colleagues assessed 24-week outcomes for the anti-interleukin-23p19 monoclonal antibody using a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study. The researchers included five study arms in their analysis: 78 patients received 200 mg tildrakizumab every 4 weeks; 79 patients were assigned 200 mg of the drug every 12 weeks; 77 were assigned 100 mg every 12 weeks; 78 patients received 20 mg every 12 weeks through week 24; and 79 patients were treated with placebo every 4 weeks until week 24.
Results at 24 weeks showed that the first study group demonstrated a 64.2% PASI75 rate and a 47.2% PASI90 rate. Rates for the second study group were 79.6% for PASI75 and 50% for PASI90, while those for the third arm were 55.6% for PASI75 and 38% for PASI90. Outcomes for the fourth active treatment arm were 46.3% for PASI75 and 36.6% for PASI90. By comparison, patients treated with placebo showed a PASI 5 rate of 16.7% and a PASI90 rate of 7.1%.
Similarly, looking at the ACR20 outcome, all four treatment groups showed separation from placebo. Significant improvements compared with placebo were seen in patients treated with 200 mg every 4 weeks (P < .001); those treated with 200 mg every 12 weeks (P < .001); those treated with 100 mg every 12 weeks (P < .05); and those treated with 20 mg every 12 weeks (P < .05).
Comparable results were observed for ACR50 and ACR70 criteria.
Safety data showed that serious treatment-emergent adverse events occurred in 2.2% of patients in the active study arms and 2.5% of those treated with placebo. There were no treatment-associated discontinuations.
Nasopharyngitis was the most commonly reported event in the pooled tildrakizumab group, at 5.4%, compared with 6.3% for placebo. Diarrhea occurred in 1.3% of all patients treated with tildrakizumab and 0% of those treated with placebo. The researchers did not observe candidiasis, inflammatory bowel disease, major adverse cardiac events or malignancies, according to the findings.
Shortening the dosing interval from every 12 weeks to every 4 weeks for the 200-mg dose failed to improve skin or joint response, the researchers concluded.
“A promising role is suggested for tildrakizumab in the treatment of patients suffering with psoriatic arthritis,” Mease said. – by Rob Volansky
Reference:
Mease PJ, et al. LB0002. Presented at: EULAR Annual Congress; June 12-15, 2019; Madrid.
Disclosure: Mease reports associations with AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Leo, Eli Lilly, Galapagos, Genentech, Gilead, Leo, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, Inc., and UCB.