Janssen psoriasis drug beats placebo
pharmafile | March 25, 2014 | News story | Research and Development, Sales and Marketing | Janssen, dermatology, guselkumab
One of Janssen’s investigational drugs has done far better than placebo when it comes to treating patients with moderate to severe plaque psoriasis.
Anti-Interleukin-23 monoclonal antibody guselkumab (CNTO 1959) cleared or greatly reduced patients’ patches of thick, red or inflamed skin covered with silvery scales (plaques) in the Phase 2b X-PLORE study.
Up to 86% of patients achieved a Physician’s Global Assessment (PGA) score of cleared (0) or minimal (1) at week 16 – the study’s primary endpoint.
Secondary endpoints included at least a 75% improvement in psoriasis as measured by the Psoriasis Area Severity Index (PASI 75) at week 16.
The findings, presented at the 2014 Annual Meeting of the American Academy of Dermatology, demonstrated “significantly higher” levels of efficacy at all doses of guselkumab at week 16 when compared with the placebo group.
Similar proportions of patients achieving a PGA score of 0 or 1 were observed at week 40.
The trial also included an arm with patients taking Humira (adalimumab), and guselkumab performed better than AbbVie’s brand in several measures.
Guselkumab is also being investigated for the treatment of active rheumatoid arthritis in a Phase II study.
“The efficacy of guselkumab in the treatment of moderate to severe plaque psoriasis looks promising according to these Phase IIb study results,” says Kristina Callis Duffin, study investigator and assistant professor of dermatology at the University of Utah School of Medicine.
“We look forward to progressing guselkumab into Phase III development based on the findings from the X-PLORE study and we remain focused and committed to advancing the treatment of psoriasis,” says Newman Yeilding, Janssen R&D’s head of immunology development.
Patients received subcutaneous injections of either placebo, guselkumab (in five dose groups) or Humira (80 mg initially, followed by 40mg every other week starting one week after initial dose).
Beyond week 16, the proportions of patients achieving a PGA score of 0 or 1, a PASI 75 response and a PASI 90 response remained consistent or showed additional improvement for guselkumab to the final dosing visit at week 40.
Adam Hill
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