Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA (guselkumab) and Long-Term Safety Profile for STELARA (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease

Published: 2022-05-25 10:47:36 ET JNJ

SPRING HOUSE, Penn. - The Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the Phase 2 GALAXI 1 clinical trial of TREMFYA (guselkumab) in adult patients with moderately to severely active Crohn's disease (CD), and from three separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with STELARA (ustekinumab).1,2,3,4 These data are being presented as oral and poster presentations and are among 29 Janssen abstracts presented during the Digestive Disease Week (DDW) meeting taking place in person and virtually in San Diego, California on May 21-24, 2022.

The GALAXI 1 data showed study participants with an inadequate response or intolerance to conventional therapies and/or biologics treated with TREMFYA achieved high levels of clinical-biomarker responsea (47.5-66.7 percent), endoscopic responseb (44.3-46 percent), and clinical remissionc with C-reactive protein (CRP) ?3 mg/L or fecal calprotectin ?250 ?g/g (39.3-66.7 percent) at 48 weeks across dose groups.1 TREMFYA is not approved to treat adult patients with CD or UC in the U.S.5

The STELARA pooled analyses of long-term safety data in bio-naive and bio-failure CD/UC patients treated with STELARA demonstrated a favorable safety profile consistent with analyses in the overall inflammatory bowel disease (IBD) population and the established safety profile across approved indications.2,3 In addition, a STELARA pooled safety analysis from 13 total studies across all approved indications (including data up to one year in psoriatic arthritis [PsA], two in UC, and five in CD and plaque psoriasis [PsO]), showed no increased incidence (adjusted for duration of follow up) of malignancy with STELARA treatment compared to placebo.4

'These new data from the GALAXI 1 study are encouraging as we continue to investigate long-term treatment solutions to address the unmet needs for our patients who live with the burden of moderately to severely active Crohn's disease,' said GALAXI 1 presenting study author Remo Panaccione, M.D., Professor of Medicine and Director of the Inflammatory Bowel Disease Unit at the University of Calgary, Alberta, Canada.d 'The clinical-biomarker response and endoscopic response data from the Phase 2 GALAXI 1 clinical trial build upon the study's clinical remission outcomes and give us insight into the potential that TREMFYA may provide sustained remission.'

New GALAXI week 48 analyses (oral presentation #888) show: 1

Clinical-biomarker response:a The proportions of patients treated with TREMFYA across dose groupse (n=185) who achieved clinical-biomarker response at week 48 ranged from 47.5-66.7 percent.f,g

Endoscopic response:b The proportions of patients treated with TREMFYA achieving endoscopic response ranged from 44.3-46 percent across dose groupse (n=185) at week 48.f

Clinical remission and achieving CRP or fecal calprotectin normalization:c The proportions of patients treated with TREMFYA achieving clinical remission and CRP ?3 mg/L or fecal calprotectin ?250 ?g/g ranged from 39.3-66.7 percent across dose groups (n=185).e,f,h

Safety: Safety results were consistent with the known safety profile of TREMFYA in approved indications.

Janssen previously announced 48-week clinical remission and corticosteroid-free clinical remission results from the GALAXI 1 Phase 2 study.6 Phase 3 clinical trials evaluating TREMFYA for the treatment of moderately to severely active CD are ongoing and actively enrolling participants. Learn more through the Janssen Global Trial Finder.

STELARA long-term pooled safety analyses showed:

Safety profile similar to placebo in bio-naive patients: In a pooled long-term safety analysis of four Phase 2/3 IBD studies, 771 bio-naive patientsi received STELARA with 1511 patient-years of follow up and 425 bio-naive patients received placebo with 376 patient-years of follow up.3 Event rates adjusted per 100 patient-years for adverse events (AEs), serious AEs, infections, serious infections, major adverse cardiac events (MACE), and malignancies were similar between STELARA and placebo through up to one year.3 Rates per 100 patient-years (adjusted for duration of follow up) for AEs, serious AEs, infections, serious infections, and MACE were similar and/or numerically lower for STELARA versus placebo through up to five years in bio-naive patients with CD and up to two years in bio-naive patients with UC (Poster #Tu1440).3

Safety profile similar to placebo in bio-failure patients: In a pooled long-term safety analysis of five Phase 2/3 IBD studies, 1596 bio-failurej patients with 1970 patient-years of follow up received STELARA and 847 bio-failure patients with 473 patient-years of follow up received placebo.2 Event rates per 100 patient-years (adjusted for duration of follow up) for AEs, serious AEs, infections, serious infections, MACE, and malignancies were similar between STELARA and placebo through up to five years in bio-failure patients with CD and up to two years in bio-failure patients with UC.2 The safety profile of STELARA was consistent with the established safety profile in IBD and across approved indications (Poster #Tu1438).2

Malignancy risk comparable to placebo: In an analysis of pooled long-term safety data from 13 studies across approved indications, including CD and UC, in 2501 placebo-treated patients with 1244 patient-years of follow up and 6710 STELARA-treated patients with 13807 patient-years of follow up, STELARA showed no increased incidence (adjusted for duration of follow up) of malignancy compared to placebo through up to five years of STELARA follow up.4 Comparisons between the number of malignancies observed for patients treated with STELARA compared to expected malignancies based on the National Institutes of Health Surveillance, Epidemiology, and End Results database (SEER),7,k which does not include nonmelanoma skin cancer (NMSC) and cervical cancer in situ,8 resulted in a standard incidence ratio (SIR)l of 0.85 (95 percent confidence intervals:m 0.65, 1.09) for STELARA across approved indications, suggesting no increased malignancy risk with STELARA treatment. (Oral presentation #14).4

'These data provide validation and underscore our commitment to continuing to innovate for patients with disease where considerable need remains,' said Jan Wehkamp, M.D., Ph.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. 'Drawing from a two-decade legacy of immunology innovation, we continue to generate new evidence for STELARA and are investing deeply in our pipeline to usher in a new era of treatment, leveraging the continued research of pathway science aiming to establish TREMFYA as a trusted therapeutic option for healthcare professionals and people who are living with inflammatory bowel disease.'

a. Clinical-biomarker response is defined as clinical response and ?50 percent reduction from baseline in CRP or fecal calprotectin.1

b. Endoscopic response is defined as ?50 percent improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) or SES-CD ?2.1 SES-CD score at week 48 was based on all observed segments scored at week 48. Subjects who had insufficient data to calculate the total SES-CD score at week 48 were considered not to be in endoscopic response.1

c. Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of