Interim results at 24 weeks show that 75.3% of patients treated with tildrakizumab achieved a 20% improvement compared to 50.6% with placebo.
Philip Mease, MD
Interim results from a phase 2 study of tildrakizumab (Ilumya) in patients with active psoriatic arthritis showed that 75.3% of patients treated with tildrakizumab achieved ACR20—a 20% improvement in joint and skin symptoms—at week 24.
For comparison, 50.6% of participants in the placebo group achieved ACR20 at 24 weeks.
The research was presented at a late-breaking session at the European Congress of Rheumatology (EULAR 2019) in Madrid, Spain, by Philip Mease, MD, director of rheumatology research at the Swedish Medical Center/Providence St Joseph Health and clinical professor at the University of Washington School of Medicine, Seattle, WA.
"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% improvement in psoriatic arthritis symptoms and about a quarter saw a 70% improvement within 24 weeks," said Mease. "These data insights are promising for patients who continue to struggle with the impact psoriatic arthritis has on their daily lives."
The 52-week phase 2 study included 391 adult patients with active psoriatic arthritis who were randomized to receive either of 4 groups: tildrakizumab 200 mg every 4 weeks (Q4W; n = 78), tildrakizumab 200 mg every 12 weeks (Q12W; n = 79), tildrakizumab 100 mg Q12W (n = 77), tildrakizumab 20 mg Q12W (n = 78), or placebo Q4W (n = 79).
An average of 47.1% of patients receiving any dose of tildrakizumab reached a 50% improvement (ACR50) compared to 24.1% of patients receiving placebo.
At 24 weeks, all 4 groups receiving tildrakizumab were significantly more likely to achieve skin improvements as measured by the Psoriasis Area and Severity Index (PASI 75, PASI 90): tildrakizumab 200 mg Q4W (64.2%, 47.2%, respectively; P <.0001 for both), tildrakizumab 200 mg Q12W (79.6%, 50.0%; P <.0001), tildrakizumab 100 mg Q12W (55.6%, 38.9%; P <.0001, P <.001), tildrakizumab 20 mg Q12W (46.3%, 36.6%; P <.05), or placebo Q4W (16.7%, 7.1%).
The most common treatment-emergent adverse events (TEAEs) reported through week 24 were nasopharyngitis (pooled tildrakizumab arms: 5.4% [17/312]; placebo: 6.3% [5/79]); and diarrhea (tildrakizumab arms: 1.3% [4/312]; placebo: 0). No participants discontinued participation due to TEAEs and there were no reported deaths.
"We are committed to the continued clinical development of Ilumya and are pleased with the interim results in our first study for psoriatic arthritis," said Kyle Ferguson, Business Unit Head, Vice President Sales & Marketing, Sun Pharma. Ferguson added that the company is discussing the possibility of a phase 3 trial in psoriatic arthritis with regulatory authorities.
Tildrakizumab-asmn (Ilumya) was approved by the US Food and Drug Administration (FDA) in 2018 for the treatment of moderate to severe plaque psoriasis in adults eligible for systemic therapy or phototherapy.
The abstract, “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,” was presented on June 14 at EULAR 2019.