P3568 - Network Meta-Analysis to Evaluate the Comparative Efficacy of Biologics for Maintenance Treatment of Adult Patients With Crohn’s Disease

Tuesday, October 24, 2023

10:30 AM – 4:00 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

Stefan Schreiber, MD

University Hospital Schleswig Holstein
Kiel, Schleswig-Holstein, Germany

Award: Presidential Poster Award

Stefan Schreiber, MD¹, Silvio Danese, MD, PhD², Jean-Frederic Colombel, MD³, Tadakazu Hisamatsu, MD, PhD⁴, Peter M.. Irving, MD⁵, Hyunsoo Park, PharmD⁶, Dong-Hyeon Kim, DVM, PhD⁶, Young Nam Lee, PhD⁶, Stephen B.. Hanauer, MD, FACG⁷
¹University Hospital Schleswig Holstein, Kiel, Schleswig-Holstein, Germany; ²IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Lombardia, Italy; ³Icahn School of Medicine at Mount Sinai, New York, NY; ⁴Kyorin University School of Medicine, Tokyo, Tokyo, Japan; ⁵Guy’s and St. Thomas’ NHS Foundation Trust, London, England, United Kingdom; ⁶Celltrion Healthcare Co., Ltd., Incheon, Inch'on-jikhalsi, Republic of Korea; ⁷Northwestern University Feinberg School of Medicine, Chicago, IL

Introduction: Despite currently expanding therapeutic options in Crohn’s disease (CD), direct evidence on comparative efficacy of various treatments is lacking. CT-P13 subcutaneous (SC) provides patients with a new opportunity for maintenance treatment of their disease.

Methods: A network meta-analysis (NMA) was conducted to evaluate comparative efficacy of biologics. Phase 3 randomised controlled trials (RCTs) evaluating biologics approved by the European Medicines Agency or United States Food and Drug Administration as of 31 March 2023 for maintenance treatment of adult patients with moderate-to-severe CD were included. Each study was either controlled with placebo (PBO) or an active comparator. Head-to-head studies directly comparing efficacy of licensed biologics (including those with treat-through designs) were also included. Clinical remission rates were compared in a Bayesian NMA fixed-effect model.

Results: Overall, 8 RCTs were included in the analysis (ACCENT I, LIBERTY-CD, CHARM, SEAVUE, GEMINI 2, VISIBLE 2, IM-UNITI, FORTIFY). Most studies enrolled both naïve and biologic- and/or Janus kinase inhibitor-exposed patients, apart from ACCENT-1 and SEAVUE which enrolled only anti-tumour necrosis factor- and biologic-naïve patients, respectively. The present NMA was conducted using data pooled from all patients. Among 8 comparator arms, infliximab (IFX) SC 120 mg every 2 weeks (Q2W) showed the highest odds ratio (95% confidence interval [CI]) vs. PBO (3.52 [2.18–5.65]), followed by adalimumab (ADL) SC 40 mg Q2W (2.92 [1.90–4.47]), ustekinumab (UST) SC 90 mg every 8 weeks (Q8W) (2.79 [1.85–4.21]), IFX IV 5 mg/kg Q8W (2.55 [1.29–5.27]), vedolizumab (VDZ) IV 300 mg Q8W (2.33 [1.43–3.86]), risankizumab (RZB) SC 180 mg Q8W (1.80 [1.15–2.84]), VDZ SC 108 mg Q2W (1.76 [1.14–2.70]), and RZB SC 360 mg Q8W (1.60 [1.00–2.52]). In addition, IFX SC 120 mg Q2W ranked highest in terms of SUCRA values (0.887), followed by ADL SC 40 mg Q2W (0.763), UST SC 90 mg Q8W (0.718), IFX IV 5 mg/kg Q8W (0.630), VDZ IV 300 mg Q8W (0.566), RZB SC 180 mg Q8W (0.353), VDZ SC 108 mg Q2W (0.327), RZB SC 360 mg Q8W (0.252), and PBO (0.005).

Discussion: IFX SC 120 mg Q2W ranked first for achieving clinical remission. Our data might help place IFX SC into the perspective of other therapies and address knowledge gaps on the comparative efficacy of licensed biologics for CD.

Disclosures: Data have been first submitted to UEGW 2023. References are to be listed in the presentation as per the Abstract Submission Instruction of ACG 2023.

Disclosures:

Stefan Schreiber: AbbVie – Consultant, Speakers Bureau. Arena – Consultant. Biogen – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb, – Consultant, Speakers Bureau. Celgene – Consultant. Celltrion – Advisory Committee/Board Member, Consultant. Eli Lilly – Consultant, Speakers Bureau. Falk Pharma – Consultant, Speakers Bureau. Fresenius – Consultant. Galapagos/Gilead – Consultant, Speakers Bureau. Hikma – Consultant, Speakers Bureau. IMAB – Advisory Committee/Board Member, Consultant. Janssen – Consultant, Speakers Bureau. MSD – Consultant, Speakers Bureau. Mylan – Advisory Committee/Board Member, Consultant. Pfizer – Consultant, Speakers Bureau. Protagonist – Consultant. Provention Bio – Consultant. Takeda – Consultant, Speakers Bureau. Theravance – Consultant.

Silvio Danese: AbbVie – Consultant, personal fees (lecture fees). Alimentiv – Consultant. Allergan – Consultant, personal fees. Amgen – Consultant, lecture fees. Applied Molecular Transport – Consultant. AstraZeneca – Consultant, personal fees. Athos Therapeutics – Consultant, personal fees. Biogen – Consultant, personal fees. Boehringer Ingelheim – Consultant, personal fees. Bristol Myers Squibb – Consultant. Celgene – Consultant, personal fees. Celltrion Healthcare – Consultant, Personal fees. Dr Falk Pharma – Consultant. Eli Lilly – Consultant, personal fees. Enthera – Consultant, personal fees. Ferring Pharmaceuticals – Consultant, lecture fees. Gilead – Consultant, lecture fees. Hospira – Consultant, personal fees. Inotrem – Consultant, personal fees. Janssen Pharmaceuticals – Consultant, lecture fees. Johnson & Johnson – Consultant, personal fees. Morphic – Consultant. MSD – Consultant, personal fees. Mundipharma – Consultant, personal fees. Mylan – Consultant, lecture fees. Pfizer – Consultant, lecture fees. Roche – Consultant, personal fees. Sandoz – Consultant, personal fees. Sublimity Therapeutics – Consultant, personal fees. Takeda – Consultant, lecture fees. Teladoc Health – Consultant. TiGenix – Consultant, personal fees. UCB – Consultant, personal fees. Vial – Consultant. Vifor – Consultant, personal fees.

Jean-Frederic Colombel: AbbVie – Consultant, Grant/Research Support, lecture fees. Allergan – Consultant, Speakers Bureau. Amgen – Consultant, Speakers Bureau. AnaptysBio – Consultant. Arena Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, Speakers Bureau. Celgene Corporation – Consultant. Celltrion – Consultant. Eli Lilly – Consultant. Enterome – Consultant. Ferring Pharmaceuticals – Consultant, Speakers Bureau. Galmed Research – Consultant. Genentech (Roche) – Consultant. Gilead – Consultant. Glaxo Smith Kline – Consultant. Immunic – Consultant. Imtbio – Consultant. Inotrem – Consultant. Intestinal Biotech Development – Stock Options. Invea – Consultant. Ipsen – Consultant. Iterative Scopes – Consultant. Janssen Pharmaceuticals – Consultant, Grant/Research Support. Kaleido Biosciences – Consultant. Landos – Consultant. LimmaTech Biologics AG – Consultant. Medimmune – Consultant. Merck – Consultant. Microba Life Science – Consultant. Novartis – Consultant. O Mass – Consultant. Otsuka Pharmaceutical – Consultant. Pfizer – Consultant. Prometheus – Consultant. Protagonis Therapeutics – Consultant. Sanofi – Consultant. Seres – Consultant. Shire – Consultant, Speakers Bureau. Takeda – Consultant, Grant/Research Support, lecture fees. Teva – Consultant. TiGenix – Consultant. Viela Bio – Consultant. Vifor – Consultant.

Tadakazu Hisamatsu: AbbVie GK – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Alfresa Pharma Corporation and EA Pharma Co., Ltd – Grant/Research Support. Daiichi-Sankyo – Grant/Research Support. EA Pharma Co, Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Eli Lilly – Consultant. Gilead Sciences – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Janssen Pharmaceutical K.K. – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. JIMRO Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. KISSEI PHARMACEUTICAL CO., LTD – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Kyorin Pharmaceutical Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Mitsubishi Tanabe Pharma Corporation – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Mochida Pharmacuetical Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Nichi-Iko Pharmaceutical Co., Ltd – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Nippon Kayaku Co., Ltd – Grant/Research Support. Pfizer Japan Inc. – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Takeda Pharmaceutical Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Zeria Pharmaceutical Co., Ltd – Grant/Research Support.

Peter Irving: AbbVie – Advisory Committee/Board Member, lecture fees. Arena – Advisory Committee/Board Member. Boehringer-Ingelheim – Advisory Committee/Board Member. Bristol Myers Squibb – Advisory Committee/Board Member, lecture fees. Celgene – Advisory Committee/Board Member, lecture fees. Celltrion – Advisory Committee/Board Member, Grant/Research Support, lecture fees. Eli Lilly – Advisory Committee/Board Member, lecture fees. Falk Pharma – lecture fees. Ferring – lecture fees. Galapagos – Grant/Research Support, lecture fees. Genetech – Advisory Committee/Board Member. Gilead – Advisory Committee/Board Member, lecture fees. Hospira – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member, lecture fees. MSD – Advisory Committee/Board Member, Grant/Research Support, lecture fees. Pfizer – Advisory Committee/Board Member, Grant/Research Support, lecture fees. Pharmacosmos – Advisory Committee/Board Member. Prometheus – Advisory Committee/Board Member. Roche – Advisory Committee/Board Member. Samsung Bioepis – Advisory Committee/Board Member. Sandoz – Advisory Committee/Board Member, lecture fees. Sapphire Medical – lecture fees. Shire – lecture fees. Takeda – Advisory Committee/Board Member, Grant/Research Support, lecture fees. Tillots – lecture fees. Topivert – Advisory Committee/Board Member. VH2 – Advisory Committee/Board Member. Vifor Pharma – Advisory Committee/Board Member. Warner Chilcott – Advisory Committee/Board Member, lecture fees.

Hyunsoo Park: Celltrion Healthcare – Employee.

Dong-Hyeon Kim: Celltrion Healthcare – Employee.

Young Nam Lee: Celltrion Healthcare – Employee.

Stephen Hanauer: AbbVie – Consultant, Speakers Bureau. Allergan – Advisor or Review Panel Member, Consultant. Amgen – Consultant. arena – Advisor or Review Panel Member, Consultant. BMS – Advisor or Review Panel Member, Consultant, Speakers Bureau. Boehringer Ingelheim – Consultant, participating in Data and Safety Monitoring Boards. Celgene – Consultant. Celltrion – Consultant. Fresenius Kabi – Consultant. Genentech – Consultant, Grant/Research Support. Gilead – Consultant, Grant/Research Support. Gossamer – Advisor or Review Panel Member. GSK – Consultant, Grant/Research Support. InDex – Advisor or Review Panel Member. Intercept – Advisor or Review Panel Member. Janssen – Consultant, Speakers Bureau. Lilly – Consultant, Speakers Bureau. Merck – Consultant. Morphic – Consultant. Novartis – Consultant. Pfizer – Consultant, Speakers Bureau. Progenity – Consultant. Prometheus – Advisor or Review Panel Member, Consultant, Grant/Research Support. Protagonist – Advisor or Review Panel Member, Consultant. Salix – Consultant. Samsung Bioepis – Consultant. Seres – Consultant. Takeda – Consultant, Grant/Research Support, Speakers Bureau. TTL Pharma – Consultant. Ventyx – Advisor or Review Panel Member.

Stefan Schreiber, MD¹, Silvio Danese, MD, PhD², Jean-Frederic Colombel, MD³, Tadakazu Hisamatsu, MD, PhD⁴, Peter M.. Irving, MD⁵, Hyunsoo Park, PharmD⁶, Dong-Hyeon Kim, DVM, PhD⁶, Young Nam Lee, PhD⁶, Stephen B.. Hanauer, MD, FACG⁷. P3568 - Network Meta-Analysis to Evaluate the Comparative Efficacy of Biologics for Maintenance Treatment of Adult Patients With Crohn’s Disease, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.