Dive Brief:
- Janssen Research & Development said March 3 that additional Phase 3 trial results found adults with moderate to severe plaque psoriasis who were treated with guselkumab showed significant improvements in skin clearance and other measures of disease activity compared with placebo. They also showed significantly greater improvements compared with AbbVie’s blockbuster Humira (adalimumab).
- New findings are from VOYAGE 2, the second Phase 3 study evaluating guselkumab, a subcutaneously administered anti-interleukin (IL) 23 monoclonal antibody. VOYAGE 1, which reported results in October 2016 on treating the same type of patients, found that guselkumab showed significant efficacy compared with Humira for all major study endpoints through 48 weeks of treatment.
- In NAVIGATE, the third of the three pivotal Phase 3 studies, patients switching to guselkumab because of an inadequate response to Janssen’s other psoriasis drug, Stelara (ustekinumab), an anti-interleukin (IL)-12/23 monoclonal antibody, showed significantly greater improvements in skin clearance than patients staying with Stelara.
Dive Insight:
Currently, guselkumab is under review by health authorities in the U.S. and EU as a subcutaneous therapy for moderate to severe plaque psoriasis. According to estimates, up to 125 million people worldwide have the inflammatory autoimmune disease; and 20% have moderate to severe cases.
In VOYAGE 2, 84.1% of patients on guselkumab were assessed at week 16 as having cleared or minimal disease, compared with 8.5% of patients getting placebo, according to Janssen. Seven in 10 patients getting guselkumab had a Psoriasis Area Severity score showing near complete skin clearance, versus 2.4% of patients on placebo.
Moreover, guselkumab outperformed Humira on these indexes at weeks 16 and 24 in the VOYAGE 2 trial, Janssen said.
Despite Janssen’s positive late-stage data on guselkumab, some industry observers wonder how well it can position itself against several psoriasis treatments that have entered the market over the past 18 months. These include Novartis’s Cosentyx (secukinumab), Eli Lilly’s Taltz (ixekizumab) and, most recently, Valeant’s Siliq (brodalumab).
At the American Academy of Dermatology’s annual meeting March 3-7 in Orlando, Florida, an overview of the latest psoriasis treatments was given during a therapeutic hotline session by Mark Lebwohl, professor and chair of the department of dermatology at Mount Sinai’s Icahn School of Medicine. He said such therapies have “certainly been a blessing for our patients, [but] not such a blessing for our pocketbooks.”
Separately, data from Janssen’s three Phase 3 trials evaluating guselkumab for psoriasis also were being presented at AAD’s meeting. Results for the ongoing VOYAGE 1/2 trials, through week 48, were recently published in the Journal of the American Academy of Dermatology.
Guselkumab was developed by Janssen using antibody technology licensed from German-based MorphoSys AG. Marlies Sproll, MorphoSys’s chief scientific officer, said the company is encouraged by the latest positive findings. Results of these studies were already included in Janssen's regulatory filings of guselkumab in the U.S. and Europe, Sprolls noted.
Janssen anticipates gathering data with extension studies that will follow the 1,800-some patients enrolled in VOYAGE 1 and 2 for about five years.
Separately, Janssen said results of a Phase 2 study evaluating guselkumab to treat patients with active psoriatic arthritis, first presented at the 2016 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting, also will be presented at AAD’s annual meeting 2017.