Ilumya (tildrakizumab) was shown to be safe and effective in controlling moderate to severe psoriasis for adults through 5 years of treatment in a recent study.
Ilumya (tildrakizumab) was shown to be safe and effective in controlling moderate to severe psoriasis for adults through 5 years of treatment, in an extension study conducted in Japan of the global reSURFACE 1 phase 3 study.
Outcomes in the study, published in Journal of Dermatology, were determined based on scores on 2 indices: the Psoriasis Area and Severity Index (PASI) and the Physician Global Assessment (PGA).
Those with at least 50% improvement from baseline in the index (PASI 50) after treatment with tildrakizumab for 64 weeks were offered the chance to enter Japan’s optional long-term extension study and continue the drug for an additional 192 weeks. Patients received either 100-mg or 200p-mg doses.
Most patients in the extension study retained benefits from tildrakizumab. In fact, despite a higher burden of disease at baseline compared with the original reSURFACE 1 study, 5-year efficacy results in Japanese patients were comparable to or exceeded the 3-year efficacy results for the entire study population in reSURFACE 1.
Among patients receiving 100 mg who achieved PASI 75 (75% improvement from baseline), PASI 90 (90% improvement from baseline), and PASI 100 (complete resolution) after the base study, 85%, 70%, and 63% maintained response at extension study week 192, respectively. For those receiving 200 mg with PASI 75, PASI 90, and PASI 100, 88%, 96%, and 67% maintained response at week 192, respectively. And among patients with PGA 0/1 response at week 64, 68% of patients receiving 100 mg and 72% of patients receiving 200 mg maintained response at week 192.
Tildrakizumab also was generally well tolerated, the study found, with the researchers seeing low incidences of severe infections, malignancies, confirmed major adverse cardiac events, and hypersensitivity reactions.
Tumor necrosis factor antagonists and interleukin 17 (IL-17) inhibitors are other treatments for psoriasis, but each poses its own risk of adverse events (AEs).
This study was the first to assess the anti–interleukin 23p19 (IL-23p19) monoclonal antibody in Japanese patients over a 5-year timeframe, the authors said. The focus of Japanese researchers has been on long-term efficacy, and studies in Japan have found 24-month treatment persistence rates for first biologic psoriasis treatments ranging from 41% for infliximab (Avsola) to 72% for ustekinzumab (Stelara).
The extension of reSURFACE 1 (NCT01722331)—which was a 3-part, double-blind, randomized, controlled study—entailed patients receiving tildrakizumab at the same dose as at the completion of the base study; the dose was administered every 12 weeks. A total of 120 Japanese patients entered the extension study, with 79.6% (n = 43) of patients receiving 100 mg and 87.9% (n = 58) of patients receiving 200 mg completing the study.
IL-23p19 antagonists have reported a lower incidence of AEs than other biologics, the authors said. When they did occur, however, they included serious infections, malignancies, a major adverse cardiovascular event, and drug hypersensitivity reactions. The incidence of AEs in the extension study were low. The medication was discontinued in 1.7 patients per 100 patient-years for those on 100 mg, and only 0.8 per 100 patient-years for those on 200 mg.
“We are the first to present mean improvements in absolute PASI scores over time that were maintained up to week 192 in Japanese patients,” the investigators concluded, “measurements that we feel are valuable to physicians and patients during their discussions about drug response and durability of response.”
Imafuku S, Nakagawa H, Igarashi A, et al. Long‐term efficacy and safety of tildrakizumab in Japanese patients with moderate to severe plaque psoriasis: Results from a 5‐year extension of a phase 3 study (reSURFACE 1). J Dermatol. Published online February 1, 2021. doi:10.1111/1346-8138.15763