Janssen Pharmaceutical, a Johnson & Johnson company, announced data from its ECLIPSE Phase III clinical trial of Tremfya (guselkumab) in moderate to severe plaque psoriasis. The results were presented at the 3rdInflammatory Skin Disease Summit (ISDS) held in Vienna.
Tremfya was being compared to Novartis’ Cosentyx (secukinumab) in a head-to-head study. In the trial, Tremfya showed that 84.5 percent of patients treated with the drug achieved at least 90 percent improvement in their baseline Psoriasis Area Severity Index (PASI) score at 48 weeks. This compared to 70 percent of patients receiving Cosentyx.
ECLIPSE pulled together six major secondary endpoints to control for multiple comparisons, including both shorter and longer-term analyses. Although the primary endpoint was definitely a win for Janssen, the secondary endpoints were a bit more mixed. For example, Tremfya showed non-inferiority to Cosentyx in the first major secondary endpoint, with 84.6 percent of patients receiving Tremfya achieving a PASI 75 response at weeks 12 and 48comparedd to 80.2 percent on Cosentyx. That’s “non-inferior,” but not superior.
Janssen stated, “Because superiority was not demonstrated for the first major secondary endpoint, p-values for all the subsequent major secondary endpoints were considered nominal.”
The trial evaluated 1,048 patients. Plaque psoriasis causes dry, flaky and itchy patches of skin. Approximately 7.5 million people in the U.S. live with plaque psoriasis, with about 20 percent having moderate to severe forms of the disease.
Tremfya was first approved in July 2017 in the U.S. for plaque psoriasis. It is also being evaluated for psoriatic arthritis and Crohn’s disease.
Cosentyx was approved in the U.S. for plaque psoriasis, scalp psoriasis and psoriatic arthritis. It brought in $2.1 billion for Novartis last year.
“Fortunately for patients, there are many good treatment options available for plaque psoriasis today,” stated Newman Yeilding, head of Immunology Development for Janssen Research & Development. “However, to make the best recommendation for their patients from among these options, physicians need long term comparative safety and efficacy data. We’re proud to have conducted this important trial to help guide clinical practice and continue to build on the robust database of clinical information that we’ve been able to generate on guselkumab, the first IL-23 inhibitor.”
In an October pipeline update, Novartis indicated it expected Cosentyx to be the company’s largest drug in 2019, with “robust growth in all three approved indications, PSO, PSA and AS. Confidence in Cosentyx comes from 100 studies and an extensive Phase III clinical trial program, including PREVENT in non-radiographic axial spondyloarthropathy, a potential fourth indication.”
Also in October, the European Commission (EC) approved a label update for Cosentyx, for psoriatic arthritis, which will include dosing flexibility of up to 300 mg based on clinical response.
“Cosentyx has shown that it can slow the progression of joint damage inflicted by psoriatic arthritis, which can lead to significant mobility loss for patients,” stated Paul Emery, professor of Rheumatology, Arthritis Research UK and director of the Leeds NIHR Biomedical Research Centre. “The label update allows dosing flexibility up to 300 mg, giving clinicians and patients greater choice in how to target this progressive and debilitating condition, based on individual response to treatment.”
The market for these drugs is pretty crowded, with all of them chasing the Big Daddy of them all, AbbVie’s Humira. Others include Eli Lilly’s Taltz, Bausch Health’s Siliq, Amgen’s Embrel and J&J’s own Stelara.
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