SPRING HOUSE - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new open-label extension data from the Phase 3 VOYAGE 1 study, which showed high rates of skin clearance with TREMFYA (guselkumab) and no new safety signals in adult patients with moderate to severe plaque psoriasis through nearly five years of treatment.1
At week 252 in the combinedi TREMFYA group, 84 percent of patients achieved a Psoriasis Area Severity Index (PASI) 90 response (a 90 percent improvement in the PASI score compared to baseline) and 82.4 percent achieved an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) (IGA 0/1).1 Among patients in the combinedi TREMFYA group, patients were either initially randomized to TREMFYA or to placebo with crossover to TREMFYA at week 16.1 Safety outcomes were observed through 264 weeks with no new safety signals.1 TREMFYA is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor.2 These data are being presented at the 16th Annual Coastal Dermatology Symposium, which will be conducted virtually.1
'Patients with psoriasis face a life-long struggle as a result of this complex and disabling chronic disease,' said Chris Griffiths,ii M.D., Dermatology Centre, NIHR Manchester Biomedical Research Centre, Salford Royal NHS Foundation Trust, University of Manchester, Manchester, UK. 'The VOYAGE 1 TREMFYA data are the first for an IL-23 p19 inhibitor to demonstrate skin clearance for the majority of patients through nearly five years of treatment and are encouraging for patients and physicians alike as they seek long-term treatment options.'
In this Phase 3 trial, out of a total of 494 patients either randomized to TREMFYA at week 0 (n=329) or randomized to placebo and crossed over to receive TREMFYA at week 16 (n=165), 76.9 percent (380/494) continued on TREMFYA treatment through week 252. Through nearly five years of continuous TREMFYA use, PASI 90 response rates were steadily consistent based on the primary pre-specified Treatment Failure Rules (TFR). At week 52, PASI 90 response rates were 79.7 percent, 75.5 percent, and 80.6 percent based on TFR, Non-Responder Imputation (NRI), and As Observed (OBS) analyses, respectively; while corresponding rates at week 252 were 84.1 percent, 66.6 percent, and 86.6 percent. Similarly, PASI 100, IGA 0/1, and IGA 0 response rates were consistent from week 52 through week 252. Response rates were also consistent through week 252 in patients randomized to TREMFYA at week 0 (n=329). Of note, each patient may not have achieved response at each observation time point. At one year and thereafter, patients and study investigators knew that all study participants were on TREMFYA, which may affect the results.1
Safety findings were generally consistent with those previously observed.1,2 Through the end of the safety assessment (week 264) for all patients (n=774) inclusive of the combinedi TREMFYA group (n=494) and a group of patients initially treated with adalimumab who crossed over to TREMFYA (n=280), the proportion of patients reporting at least one adverse event (AE), serious AE, or discontinuation due to AEs were 87.7 percent, 16.4 percent, and 6.1 percent, respectively.1
'We are excited to share these data demonstrating TREMFYA's ability to help adults living with moderate to severe plaque psoriasis by providing sustained rates of clearance through nearly five years for the majority of patients,' said Lloyd Miller, M.D., Ph.D., Vice President, Immunodermatology Disease Area Leader, Janssen Research & Development, LLC. 'With remission as the ultimate goal, we are committed to continuing to apply the best science and disease insights to advancing therapies that improve the lives of patients.'
Psoriasis is an immune-mediated disease resulting in an overproduction of skin cells, which causes raised, red, scaly plaques that may be itchy or painful.3 It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.4 Nearly one-quarter of all people with psoriasis have cases that are considered moderate to severe.4 Living with psoriasis can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life.5
About VOYAGE 1 (NCT02207231)6
This Phase 3, randomized, double-blind, placebo and active comparator-controlled trial with 837 patients was designed to evaluate the efficacy and safety of TREMFYA compared with placebo and adalimumab in adults with moderate to severe plaque psoriasis. Patients were randomized to receive placebo (n=174) at weeks 0, 4 and 12, followed by crossover to TREMFYA (n=165) at weeks 16 and 20 followed by every eight-week (q8w) dosing; TREMFYA 100 mg (n=329) at weeks 0, 4 and 12, followed by q8w dosing; or adalimumab 80 mg (n= 334) at week 0, followed by 40 mg at week 1, then dosing every two weeks 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 vs. patients receiving placebo achieving IGA 0/1 (clear/almost clear) [73 percent vs. 3 percent, respectively; p