Janssen reveals positive CHMP opinion, long-term data for psoriasis drug guselkumab

Janssen has announced that its psoriasis drug guselkumab has been awarded a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP), recommending its use for the treatment of moderate to severe plaque forms of the condition in patients who are candidates for systemic therapy.

The company stated that the decision was based primarily on three Phase 3 clinical trials which demonstrated the drug’s efficacy compared to placebo and Abbvie’s Humira (adalimumab), currently the market leader in the space. Gulsekumab managed to beat out both over all primary and secondary endpoints, showing a 90% reduction in Psoriasis Area and Severity Index (PASI) score in up to 73.3% of patients after 16 weeks, compared to up to 48.7% with Humira.  

"People living with plaque psoriasis bear a tremendous physical and emotional burden due to the painful and visible nature of the disease, and there is a real need to improve upon current treatment options," commented José Antonio Burόn Vidal, Vice President, Medical Affairs, Europe, Middle East and Africa (EMEA). "We are pleased guselkumab may soon be available to adults living with moderate to severe plaque psoriasis in Europe, because the evidence shows this novel therapeutic offers significant and lasting efficacy for patients in need of alternative treatment options."

Alongside this announcement, Janssen also unveiled new findings on the long-term benefits of guselkumab, showing consistent efficacy up to 100 weeks of treatment. These new observations show that 80% of patients taking the drug, including those initially taking placebo or Humira, achieved at least a 90% improvement in PASI score after being treated for 100 weeks.

"These data show the rates of skin clearance with guselkumab were consistent at weeks 52 and 100 with every eight-week maintenance therapy. These important new findings contribute to the scientific evidence for targeting IL-23 in the treatment of moderate to severe plaque psoriasis," said Professor Chris Griffiths, Foundation Professor of Dermatology at the University of Manchester, UK, and study steering committee member on the study. "Also noteworthy is that skin clearance rates in patients transitioned to guselkumab from adalimumab improved and the rates were consistent at weeks 52 and100."