The results of a Phase IIB study presented at EULAR 2019 demonstrate superior efficacy and comparable safety of tildrakizumab versus placebo in patients with psoriatic arthritis.1
By week 24 in the study, a significantly higher proportion of patients receiving tildrakizumab (at any dose) achieved a 90% reduction in Psoriasis Area and Severity Index (PASI 90), and a 50% reduction in American College of Rheumatology response criteria (ACR 50) versus placebo. There were four active treatment groups in which patients received 20mg, 100mg or 200mg tildrakizumab every 12 weeks, or 200mg every four weeks. The response rates improved with increasing dose however the shortening of dosing interval of 200mg from 12 to four weeks did not result in a measurable increase in skin or joint response scores. In patients receiving 200mg tildrakizumab every 12 weeks, 79.6% and 50% achieved PASI 75 and PASI 90 respectively versus 16.7% and 7.1% in the placebo group (p<0.0001).1
“Our results demonstrate a clear separation between tildrakizumab and placebo as early as eight weeks,” said Philip Mease, MD, MACR, Swedish Medical Center/Providence St. Joseph Health and the University of Washington, Seattle, Washington, USA. “A promising role is suggested for tildrakizumab in the treatment of patients suffering with psoriatic arthritis.”
The 24-week, randomised, double-blind, placebo-controlled, multiple-dose, phase 2B study included 391 adults with psoriatic arthritis who had three or more tender and three or more swollen joints. Patients were randomised (1:1:1:1:1) to receive tildrakizumab 200mg every four weeks, 200mg, 100mg or 20mg every 12 weeks, or placebo every four weeks. Stable concomitant methotrexate or leflunomide use was permitted but not mandated.1
Serious adverse events (AEs) occurred in 2.2% of tildrakizumab-treated patents and 2.5% of placebo-treated patients. Treatment-related serious AEs occurred in 0.3% of tildrakizumab-treated patients (as judged by the investigator). The most frequent AEs included nasopharyngitis and diarrhoea with no reports of candidiasis, inflammatory bowel disease, major adverse cardiac events, or malignancy. No patients discontinued treatment due to AEs and no deaths were reported.1
- Mease PJ 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. EULAR 2019; Madrid: Abstract LB0002.