Tildrakizumab showed efficacy as treatment for patients with moderate-to-severe chronic plaque psoriasis compared with placebo or Enbrel, according to results of two phase 3 studies recently published in The Lancet.
Alexa B. Kimball, MD, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, and colleagues conducted two three-part parallel group, double-blind randomized controlled studies: reSURFACE 1 at sites in Australia, Canada, Japan, the U.K. and U.S., and reSURFACE 2 at sites in Europe, Israel and the U.S.
Alexa B. Kimball
In reSURFACE 1, which ran from Dec.10, 2012, to Oct. 28, 2015, 722 patients with moderate-to-severe plaque psoriasis were randomly assigned to tildrakizumab (Sun Pharma) 200 mg, tildrakizumab 100 mg or placebo. In the 200-mg group, 62% of patients achieved Psoriasis Area and Severity Index (PASI) 75 at week 12, as did 64% of the 100-mg group, compared with 6% of patients in the placebo group (P < .0001 for both tildrakizumab groups vs. placebo). Physician’s Global Assessment (PGA) score of “clear” or “minimal” was achieved by 59% of patients in 200 mg group, 58% in the 100-mg group and 7% in the placebo-treated group (P < .0001 for both tildrakizumab arms vs. placebo).
In reSURFACE 2, which ran from Feb. 12, 2013, to Sept. 28, 2015, 1,090 patients were randomly assigned to tildrakizumab 200 mg, tildrakizumab 100 mg, placebo or Enbrel (etanercept, Amgen). In the 200-mg group, 66% of patients achieved PASI 75 at week 12, as did 61% of patients in the 100-mg group, vs. 6% of patients in the placebo group (P < .0001 for both tildrakizumab treatments vs. placebo) and 48% in the etanercept group (P < .0001 compared with 200 mg tildrakizumab; P = .0001 compared with 100-mg tildrakizumab t).
A PGA score of clear or minimal was achieved by 59% in the 200-mg treatment arm, 55% in the 100-mg arm compared with 4% in the placebo-treated group (P < .001 both treatments vs. placebo) and 48% in the etanercept-treatment arm (P = .0031 for 200 mg vs. etanercept and P = .0663 for 100 mg vs. etanercept).
The most common adverse event was nasopharyngitis for both studies. One patient in the reSURFACE 2 receiving 100 mg tildrakizumab who had alcoholic cardiomyopathy and steatohepatitis, died on day 96, with the cause of death undetermined.
“Even in this revolutionary era of highly effective psoriasis therapies, patients with moderate-to-severe disease usually need to be treated for decades,” the researchers concluded. “These patients are still in need of long-term persistent efficacy and drugs with robust long-term safety. The refinement of therapies that increasingly narrow the range of biologic effects to only those desired, including antibodies specifically antagonizing interleukin 23 such as tildrakizumab, continues to provide momentum toward these long-term goals.” – by Bruce Thiel
Disclosure: Reich reports serving as a consultant or paid speaker for or participating in clinical trials sponsored by AbbVie, Amgen, Biogen-Idec, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, Merck & Co., Novartis, Pfizer, Vertex and Takeda. Please see the full study for a list of other researchers’ relevant financial disclosures.