golimumab/guselkumab (JNJ-4804) / J&J - LARVOL DELTA

Impact of pharmacological therapies for moderate to severe Ulcerative Colitis on health-related quality of life: a systematic review and network meta-analysis (ECCO-IBD 2025) - "Results Twenty-six randomized, double-blind, placebo-controlled trials with 14 interventions (adalimumab, etrasimod, filgotinib, golimumab, guselkumab, guselkumab/golimumab, infliximab, mirikizumab, risankizumab, tofacitinib, upadacitinib, ustekinumab, vedolizumab and placebo) assessed HRQL using the IBDQ score. Among the treatments evaluated, upadacitinib and filgotinib showed the most substantial benefits in improving IBDQ scores and were highly ranked for both IBDQ response and remission. Head-to-head trials are warranted to validate these comparative benefits and inform optimal treatment strategies."

HEOR • Retrospective data • Review • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Paediatric Inflammatory Bowel Diseases: novel agents on the therapeutic horizon (ECCO-IBD 2025) - "These include etrolizumab, golimumab, guselkumab, mirikizumab, risankizumab, ustekinumab, and vedolizumab. Sixteen trials are recruiting, examining small molecule therapies in pediatrics, to include upadacitinib, tofacitinib, etrasimod, and ozanimod...Consideration for novel trial designs and collaboration between research networks could reduce the delay in paediatric marketing approvals. Continued engagement with regulatory bodies and the international pIBD community offers a critical opportunity to advance drug approvals in children with IBD."

Immunology • Inflammation • Inflammatory Bowel Disease

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=703 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jan 2031 ➔ Nov 2029

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

BROADENED REPRESENTATION OF PATIENTS WITH ULCERATIVE COLITIS, BUT NOT CROHN’S DISEASE, IN CONTEMPORARY RANDOMISED CONTROLLED TRIALS (UEGW 2024) - "Their characteristics were compared against inclusion and exclusion criteria of recently completed or ongoing RCTs: ozanimod, upadacitinib, risankizumab, golimumab-guselkumab, guselkumab (Crohn’s disease [CD] only), filgotinib, mirikizumab, and etrasimod (ulcerative colitis [UC] only for the latter three drugs). Only a minority of patients with IBD from routine practice would be eligible for participation in contemporary RCTs, although the percentage has increased for patients with UC compared to past studies."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=703 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2029 ➔ Jan 2031

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Persistence of advanced systemic pharmacological treatment of moderate-to-severe psoriasis among bio-naïve patients-A retrospective register-based cohort study in Finland and Sweden. (PubMed, J Eur Acad Dermatol Venereol) - "Guselkumab and ustekinumab demonstrated high persistence as measured by continued treatment for at least 1 year. Furthermore, these treatments demonstrated lower rates of discontinuation compared to other study drugs included in the analysis. Understanding the balance between efficacy and feasibility in treatment decisions is crucial, as feasibility may impact persistency outcomes and potentially increase persistency rates."

Journal • Metastases • Retrospective data • Dermatology • Immunology • Psoriasis

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=577 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=703 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2029 ➔ Mar 2029

Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2029 ➔ Oct 2030

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2029 ➔ Oct 2029

Combination therapy • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Vaccination Recommendations for Adults Receiving Biologics and Oral Therapies for Psoriasis and Psoriatic Arthritis: Delphi Consensus from the Medical Board of the National Psoriasis Foundation. (PubMed, J Am Acad Dermatol) - "Interruption of anti-psoriatic oral and biologic therapies is generally not necessary for patients receiving non-live vaccines. Temporary interruption of oral and biologic therapies before and after administration of live vaccines is recommended in most cases."

Journal • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2030 ➔ Mar 2029

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2030 ➔ Mar 2029

Combination therapy • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jul 2024 ➔ May 2025

Combination therapy • Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Feb 2029 ➔ Aug 2030 | Trial primary completion date: Aug 2024 ➔ May 2025

Combination therapy • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2033 ➔ Feb 2029

Combination therapy • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P2b ➔ P2

Combination therapy • Phase classification • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P2b ➔ P2

Combination therapy • Phase classification • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2b | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Sep 2030 ➔ Oct 2033

Combination therapy • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2b | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2031 ➔ Oct 2030

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2b | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Feb 2029 ➔ Sep 2030

Combination therapy • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2b | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2030 ➔ Oct 2031

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2b | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2029 ➔ Oct 2030

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Guselkumab, Golimumab Combination Therapy Leads to High Rates of Clinical Response for Ulcerative Colitis (HCPLive) - "A team, led by Brian G. Feagan...assessed guselkumab and golimumab combination therapy as a treatment for patients with ulcerative colitis compared to either monotherapy alone.While new monoclonal antibodies and oral therapies have improved care for patients with ulcerative colitis, clinical remission rates continue to be low and new approaches to treatment could be needed."

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