A drug made by Johnson & Johnson for psoriasis that is one of the biggest revenue generators in its portfolio could be under threat in the future following the success of a new competitor in a Phase III study.

Brussels-based UCB said Thursday that results of its BE VIVID study showed that its antibody, bimekizumab, was superior in its efficacy against J&Js Stelara (ustekinumab) in adult patients with moderate-to-severe chronic plaque psoriasis.

The company did not disclose the full results, which it said would be presented in due course, but stated that the trial met the primary endpoint of showing at least a 90 percent improvement in psoriasis area and severity index or PASI90 and an investigator global assessment score of clear or almost clear after 16 weeks. The safety profile was consistent with the Phase II BE ABLE studies.

BE VIVID randomizes patients to receive bimekizumab for one year, Stelara for one year with placebo at certain time points to maintain blinding or placebo for 16 weeks followed by bimekizumab for the remainder of the study period. Bimekizumab is an IgG1 antibody tat neutralizes IL-17A and IL-17F, two key cytokines that drive inflammation.

These encouraging first results provide strong evidence that bimekizumab has the potential to raise the bar for achieving skin clearance rates in patients, investigator Dr. Mark Lebwohl of New Yorks Icahn School of Medicine said in a statement. Achieving clear skin is of critical importance in positively impacting the lives of psoriasis patients.

Stelara, which was approved in 2009, was J&Js second largest product in 2018, accounting for about 6.3 percent of its total sales for the year, with global sales of about $5.2 billion, according to its 2018 annual report. U.S. patents for Stelara are expected to expire in 2023 due to a patent term extension, followed by expiration in Europe the following year. The companys top-selling product is the autoimmune disease drug Remicade (infliximab), which had sales of $5.3 billion and which already has biosimilar competitors.

In the Phase IIb BE ABLE 1 trial, which randomized patients to various dose levels of bimekizumab or placebo, patients treated with the drug showed a statistically significant dose-dependent response for PASI90, with 46.2-79.1 percent of patients achieving it, compared with 0 percent in the placebo arm. In addition, 27.9-60 percent of bimekizumab-treated patients achieved PASI100, also compared with 0 percent in the placebo arm. Treatment-emergent adverse events occurred among 126 of the 208 patients treated with bimekizumab, compared with 15 of 42 who received placebo.

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UCB psoriasis drug beats J&J's second top-selling product in Phase III study - MedCity News