Date: 2017-09-16
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 26th European Academy of Dermatology and Venereology (EADV) Congress
Company: Janssen Research & Development, a J&J company (USA - NJ)
Product: Tremfya™ (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, Hungary, , Republic of Korea, Poland, Russian Federation, Spain, Taiwan, USA
Trial
details:
- VOYAGE 1 is a Phase 3, randomized, double-blind, placebo and active comparator-controlled trial evaluating the efficacy and safety of Tremfya™ compared with placebo and adalimumab in adults with moderate to severe plaque psoriasis. Patients (n=837) were randomized to receive placebo at weeks 0, 4 and 12, followed by crossover to Tremfya™ at weeks 16 and 20 followed by every eight-week dosing (q8w); Tremfya™ 100 mg at weeks 0, 4 and 12, followed by q8w; or adalimumab 80 mg at week 0 and 40 mg at week 1, followed by every two-week dosing through week 47, with crossover to Tremfya™ q8w at week 52. The co-primary endpoints of the study were the proportions of patients receiving Tremfya™ versus patients receiving placebo achieving IGA 0/1 (cleared/minimal disease) and PASI 90 response at week 16. Secondary endpoints were assessed at weeks 16, 24 and 48, with safety monitoring throughout the study. The open-label extension period started at week 52 and is currently ongoing. Results presented to date include findings through week 100 of the study. Through week 48, non-responder imputation rules were used for missing data while after week 48, no missing data were imputed after the application of treatment failure rules. VOYAGE 1 is part of a comprehensive Tremfya™ Phase 3 clinical development program that includes two additional Phase 3 trials, VOYAGE 2 and NAVIGATE. (NCT02207231)
Latest
news:
- • On September 16, 2017, Janssen Research & Development presented new longer-term data from the open-label extension of the VOYAGE 1 trial demonstrating consistent rates of skin clearance with Tremfya™ (guselkumab) treatment through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody. The longer-term findings from the Phase 3 VOYAGE 1 study presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress showed more than 80 percent of patients receiving Tremfya™ , including those initially treated with placebo or the anti-tumor necrosis factor (TNF)-alpha agent Humira® (adalimumab) achieved at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90), or near complete skin clearance, and an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 100.
- Results from the open-label extension of the Phase 3 VOYAGE 1 study showed that at week 100, among patients initially randomized to Tremfya™ , 82.4 percent achieved an IGA score of 0/1 (cleared or minimal disease) and 82.1 percent achieved a PASI 90 score (near complete skin clearance). In addition, at week 100, 53.8 percent of patients achieved an IGA score of 0 and 49.0 percent of patients achieved a PASI 100 score. These measures represent skin completely cleared of plaques and were consistent with PASI 100 and IGA 0 results demonstrated at week 52. Among patients initially randomized to receive adalimumab and transitioned to Tremfya™ at week 52, the proportion of patients achieving a PASI 90 score increased from 50.5 percent at week 52 to 81.1 percent at week 100, and the proportion of patients achieving an IGA 0/1 increased from 60.4 percent at week 52 to 84 percent at week 100. The proportion of patients who achieved PASI 100 and IGA 0 scores increased from 24 percent and 27.3 percent, respectively, at week 52 to 51.6 percent and 55.6 percent, respectively, at week 100. Results among patients initially randomized to placebo and crossed over to Tremfya™ at weeks 16 and 20 demonstrated consistent levels of skin clearance at weeks 52 and 100.
- Scores from the Psoriasis Symptoms and Signs Diary (PSSD), which evaluates patient-reported symptoms (i.e., itch, pain, stinging, burning and skin tightness) and signs (i.e., skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding), were consistent over the two-year period with Tremfya™ treatment. Patients initially randomized to receive adalimumab therapy in VOYAGE 1 and crossed over to Tremfya™ demonstrated substantial improvement in PSSD scores from week 48 to week 100. The proportion of patients reporting PSSD symptom scores of 0 (0-10 scale where a higher score indicates more severe symptoms of psoriasis) improved from 23.1 at week 48 (during adalimumab treatment) to 41.8 percent at week 100 (during Tremfya™ treatment).
- The adverse events (AEs), serious AEs and infections per 100 patient-years of follow-up through week 100 among the placebo crossover to Tremfya™ Tremfya™ group and the initial Tremfya™ group combined were 220.30, 6.5 and 87.77, respectively, which were consistent with those through week 48 (282.12, 5.84 and 110.97, respectively). No cases of active tuberculosis, opportunistic infections or serious hypersensitivity reactions were reported.
Is
general: Yes
