J&J's psoriasis drug trumps Humira in Phase 3
- Janssen, a subsidiary of J&J, over the weekend reported its IL-23 monoclonal antibody guselkumab beat out a placebo and AbbVie's Humira in a Phase 3 study testing the drug in moderate-to-severe plaque psoriasis.
- Guselkumab met both of its primary endpoints, helping 85.1% of patients hit the targeted investigator's global assessment (IGA) score of cleared or minimal disease after 4 months, compared to 6.9% of those on placebo. Over 70% of patients achieved a PASI 90 response.
- Those percentages bested the response seen among patients receiving Humira, 65.9% of whom reached an IGA score of cleared or minimal disease.
The psoriasis market has rapidly become crowded, as new therapies add to the first wave of TNF-alpha inhibiting biologics.
At each stage, the new biologic drugs are beating the standards set by the previous generation of drugs. Novartis' IL-17A inhibitor Cosentyx (secukinumab) has outstripped both Enbrel and Stelara in head-to-head clinical trials. And now, Janssen's IL-23-targeting guselkumab has beat out Humira, according to Janssen's results.
Guselkumab, which was developed using MorphoSys' HuCAL antibody technology platform, could further build upon J&J's success with Stelara and its existing psoriasis franchise.
The IL-23 inhibitors are new class of drugs for treatment of inflammatory conditions. Guselkumab will likely face several competitors, including Merck & Co’s tildrakizumab, which is expected to launch in 2017, according to Decision Resources. And on Monday, Allergan paid $250 million upfront to license AstraZeneca's MEDI2070, another IL-23 drug in testing for Crohn's disease and ulcerative colitis.
Quality of life is an important thing with skin disease, and the VOYAGE 1 study also included this as a studied outcome. At week 24, psoriasis had no impact on patients' quality of life for about 61% treated with guselkumab, compared with nearly 40% treated with Humira.
Serious adverse events were reported in a slightly higher share of patients (2.4%) on guselkumab, compared to those on Humira.
J&J has two other Phase 3 studies which are set to read out data at future scientific congresses, the company said.
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