Clinical Trials

Date: 2017-03-03

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the 2017 American Academy of Dermatology (AAD) Annual Meeting

Company: Janssen Research & Development, a J&J company (USA - NJ)

Product: guselkumab (CNTO 1959)

Action mechanism:

• monoclonal antibody. Guselkumab is a human monoclonal antibody that targets interleukin (IL)-23, and is in Phase 3 clinical development as a subcutaneously administered therapy for the treatment of moderate to severe plaque psoriasis.
•  This antibody was generated utilizing the HuCAL antibody library technology licensed from MorphoSys.

Disease: psoriasis

Therapeutic area: Autoimmune diseases - Dermatological diseases

Country: Australia, Canada, Germany, Republic of Korea, Poland, Russian Federation, Spain, Taiwan, UK, USA

Trial details:

• The Phase 3 NAVIGATE trial was a randomized, double-blind, multicenter study evaluating the efficacy and safety of guselkumab compared with Stelara® in adult patients with moderate to severe plaque psoriasis who had an inadequate response to treatment with Stelara®. Patients (n=871) received SC injections of Stelara® 45 mg or 90 mg (based on weight) at weeks 0 and 4 during open-label treatment. At week 16, patients (n=268) with an IGA score greater than or equal to 2 were considered inadequate responders and were randomized to receive guselkumab 100 mg at weeks 16 and 20 and then every eight weeks through week 44, or to continue on Stelara® every 12 weeks through week 40; patients (n=585) who achieved an IGA score of 0/1 at week 16 continued to receive Stelara® every 12 weeks through week 40. Safety results were monitored through week 60. (NCT02203032)

Latest news:

•  • On March 3, 2017, Janssen Research & Development, LLC (Janssen) announced new findings from two pivotal Phase 3 studies reporting the efficacy and safety of guselkumab in the treatment of adults with moderate to severe plaque psoriasis. These Phase 3 data are being presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in Orlando, FL, March 3-7. Data from the VOYAGE 2 study showed that patients treated with guselkumab experienced significant improvements in skin clearance and other measures of disease activity compared with placebo, and significantly greater improvements compared with the anti-tumor necrosis factor (TNF)-alpha treatment Humira® (adalimumab). VOYAGE 2 is the second Phase 3 study to demonstrate superior efficacy of guselkumab versus adalimumab following VOYAGE 1. Data from a third Phase 3 study (NAVIGATE) showed that patients who had an inadequate response following treatment with the anti-interleukin (IL)-12/23 monoclonal antibody (mAb) STELARA® (ustekinumab) and who then switched to guselkumab, showed significantly greater improvements in skin clearance compared with patients who continued to receive Stelara®.
• NAVIGATE: Efficacy and safety of switching to guselkumab in moderate to severe plaque psoriasis patients with an inadequate response to Stelara® The NAVIGATE study evaluated the efficacy and safety of guselkumab in patients who continued to experience mild to severe skin symptoms (IGA of 2 or more) following 16 weeks of treatment with Stelara®. Patients who switched to guselkumab consistently showed greater improvement in their psoriasis between weeks 28 and 40, compared with patients who continued to receive Stelara®, having twice as many office visits with at least a 2 point improvement in IGA from week 16, the study’s primary endpoint, and an IGA score of 0 or 1 (1.5 and 0.7 respectively; P < 0.001). Guselkumab also demonstrated superiority across major secondary endpoints in comparisons with Stelara®. Major secondary endpoints included the number of visits that patients achieved a PASI 90 response or IGA score of 0 between weeks 28 and 40, and the proportions of patients that achieved an IGA score of 0 or 1 with at least a 2 point improvement from week 16 at week 28 (all P ? 0.001). In addition, a significantly higher proportion of patients in the guselkumab group achieved an IGA score of 0 or 1 and at least a 2 point improvement from week 16 at week 52, and a PASI 90 response at weeks 28 and 52, compared with Stelara® (all P < 0.001).
• Through week 60, AEs were reported in 64.4 percent of patients receiving guselkumab and 55.6 percent of patients receiving STELARA®. Serious AEs were reported in 6.7 percent of patients receiving guselkumab and 4.5 percent in patients treated with STELARA®, including 3 myocardial infarctions (2 from the guselkumab-treated group and 1 from the ustekinumab-treated group) and 2 malignancies (bladder carcinoma and a fatal squamous cell carcinoma of the neck, both in the guselkumab-treated group). A serious infection occurred in 1 patient receiving guselkumab.

Is general: Yes