Clever Marketing Needed To Position J&J's New Psoriasis Drug Ahead Of Cheaper Options
Executive Summary
Despite being able to show superiority over market leader AbbVie's Humira (adalimumab), Johnson & Johnson will need to invest heavily in order to drive uptake for guselkumab if the drug is successfully approved next year for the treatment of psoriasis.
Johnson & Johnson's anti-interleukin-23 therapy, guselkumab, has produced stronger efficacy data in VOYAGE 1, the first ever Phase III study to directly compare an IL inhibitor against anti-TNF-alpha treatment Humira (AbbVie Inc.’s adalimumab) in psoriasis patients – but uptake might still be a challenge in the early treatment setting because of the number of cheaper alternatives on the market.
J&J is aiming to position guselkumab early in the psoriasis treatment algorithm by directly comparing it to the current standard of care (Humira) in its Phase III program but guselkumab will face several barriers upon launch, such as the increasing availability of lower cost anti-TNF biosimilars that will likely be used in early lines of therapy, and the increasing availability of highly efficacious IL inhibitors.
Datamonitor Healthcare analyst Anna Reyes told Scrip that guselkumab’s superiority versus Humira in the VOYAGE 1 Phase III study represents a win to J&J. However, she said the company would have to "invest heavily in order to drive guselkumab’s uptake in an attempt to protect its dermatology franchise, now that many IL inhibitors (including Novartis AG's anti-IL17a agent Cosentyx (secukinumab), Valeant Pharmaceuticals International Inc.'s anti-IL17 Siliq (brodalumab) and AbbVie's anti-IL23 product risankizumab (ABBV-066)) have demonstrated superiority to J&J’s own marketed psoriasis drug, Stelara."
Reyes added that leading dermatologists have suggested J&J may market guselkumab over the anti-IL12/IL23 product Stelara (ustekinumab) once the new IL-23 inhibitor is approved.
J&J is expected to file regulatory applications for guselkumab by the end of the year in the US and Europe. The company is also due to present more Phase III data for guselkumab from its VOYAGE 2 and NAVIGATE studies in the fourth quarter.
Head-To-Head Results
Janssen Pharmaceuticals Inc., a J&J company, reported data from the Phase III VOYAGE 1 trial – which included a head-to-head arm comparing J&J's compound against adalimumab – at the European Academy of Dermatology and Venereology (EADV) meeting held in Austria from Sept. 28 to Oct.2. Last year J&J reported positive Phase II data for guselkumab versus Humira in the same setting of moderate to severe plaque psoriasis patients.
In the VOYAGE 1 study, the co-primary endpoints were met at week 16, with 85.1% of patients receiving guselkumab 100mg at weeks 0 and 4 and then every eight weeks achieving cleared (IGA 0) or minimal disease (IGA 1) compared with 6.9% of patients receiving placebo (p<0.001). Nearly three-quarters of patients receiving guselkumab (73.3%) achieved a PASI 90 response, or near complete skin clearance, compared with 2.9% of patients receiving placebo (p<0.001).
Furthermore, all major secondary endpoints in VOYAGE 1 achieved significance in comparisons of guselkumab versus adalimumab administered subcutaneously at weeks 0 (80mg), 1 (40mg) and then 40mg every other week (p< 0.001 for all measures). At week 16, following three injections of guselkumab and ten injections of adalimumab, significantly higher proportions of patients receiving guselkumab achieved IGA 0/1 and PASI 90 (85.1% and 73.3%, respectively) compared with patients receiving adalimumab (65.9% and 49.7%, respectively).
Higher levels of skin clearance among the guselkumab group continued through weeks 24 and 48, with significantly more patients receiving guselkumab achieving IGA 0/1 and PASI 90, as well as measures of full skin clearance, as indicated by a 100% improvement in PASI score or an IGA score of 0, compared with adalimumab, Janssen reported.
The co-primary endpoints of the study were proportions of patients receiving guselkumab versus patients receiving placebo achieving cleared/minimal disease and PASI 90 response at week 16.