Janssen Biotech submits stelara approval application for plaque psoriasis
Janssen Biotech announced the submission of a Supplemental Biologics License Application (sBLA) to the FDA seeking approval of STELARA (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. It is estimated that 7.5 million Americans have psoriasis, which can range from mild to severe and disabling, and approximately one-third of those affected develop the immune-mediated disease before 20 years of age.2 STELARA, a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.
"Adolescence is an important developmental period, and a diagnosis of moderate to severe plaque psoriasis can present physical and emotional challenges for girls and boys," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development. "We look forward to collaborating with the FDA on this application with the hope that in the future, we may be able to offer STELARA to dermatologists and their adolescent patients as a new treatment option for moderate to severe plaque psoriasis."
The application is supported by data from the phase III CADMUS registration study, which evaluated the efficacy and safety of STELARA in the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. Results from the CADMUS study have been previously published in the Journal of the American Academy of Dermatology in May 2015. The efficacy and safety profile of STELARA in the CADMUS trial was consistent with the profile of this anti-IL-12/23 monoclonal antibody as previously observed in adult patients receiving STELARA.
CADMUS, a phase III, randomized, double-blind, placebo-controlled, parallel, multicenter trial, evaluated the efficacy and safety of STELARA in pediatric patients 12 to 17 years of age with moderate to severe plaque psoriasis. Patients (N=110) had been diagnosed with psoriasis more than six months prior to first study agent administration and had a Psoriasis Area Severity Index (PASI) score greater than or equal to 12, a Physician's Global Assessment (PGA) score greater than or equal to three and body surface area (BSA) involvement of at least 10%. In addition, patients were inadequately controlled with topical therapy or were candidates for systemic/phototherapy.
Patients were randomized 1:1:1 to receive subcutaneous injections of placebo, STELARA standard dosing (SD) [intended to achieve exposures comparable to adults] or STELARA half standard dosing (HSD) [intended to achieve exposures half of those seen in adults]. STELARA dosing tiers were determined by body weight. Patients receiving placebo crossed over to receive STELARA SD or HSD at weeks 12 and 16; all patients continued with maintenance dosing every 12 weeks through week 40. Final efficacy and safety evaluations were made at weeks 52 and 60, respectively. The primary endpoint of the study was a PGA score of cleared (0) or minimal (1) at week 12. Secondary endpoints at week 12 included at least a 75 or 90% improvement in psoriatic skin lesions, as measured by PASI 75 or PASI 90, and improvement in quality of life, as measured by the Children's Dermatology Life Quality Index (CDLQI) [patient-reported outcome].
A phase III study, CADMUS Jr, is currently ongoing to evaluate the efficacy and safety of STELARA in the treatment of pediatric patients 6 to 11 years of age living with moderate to severe plaque psoriasis.