P3547 - Vedolizumab Long-Term Treatment Persistence and Safety – Results From a Multinational Extended Access Program Study

Tuesday, October 24, 2023

10:30 AM – 4:00 PM PT

Location: Exhibit Hall

Presenting Author(s)

Silvio Danese, MD, PhD

IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University
Milan, Lombardia, Italy

Silvio Danese, MD, PhD¹, Milan Lukas, ², Miroslava Volfová, ³, Grażyna Rydzewska, ⁴, Shashi Adsul, MD, MBA⁵, Dirk Lindner, MSc⁶, Stephen Jones, ⁶, Séverine Vermeire, MD, PhD⁷
¹IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Lombardia, Italy; ²IBD Clinical and Research Centre, ISCARE Clinical Centre, Prague, Hlavni mesto Praha, Czech Republic; ³Institute for Clinical and Experimental Medicine, Prague, Kralovehradecky kraj, Czech Republic; ⁴Central Clinical Hospital of Ministry of Interior and Administration of Warsaw, Warsaw, Kujawsko-Pomorskie, Poland; ⁵Takeda Pharmaceuticals, Cambridge, MA; ⁶Takeda, Zurich, Zurich, Switzerland; ⁷UZ Leuven, Leuven, Vlaams-Brabant, Belgium

Introduction: Vedolizumab (VDZ) is a gut-selective humanised monoclonal anti-α₄β₇ integrin antibody for treatment of ulcerative colitis (UC) and Crohn’s disease (CD). The GEMINI Long-Term Safety (LTS) study demonstrated the durable efficacy and safety of VDZ for inflammatory bowel disease (IBD) treatment. Patients (pts) experiencing clinical benefit from VDZ in GEMINI LTS or VERSIFY studies could continue treatment in the VDZ extended access programme (XAP).

Methods: The XAP study was a phase 3b/4, prospective, open-label, multinational, interventional study (NCT02743806) conducted from Aug 2016 to Jan 2023 to investigate long-term treatment persistence and safety of VDZ 300mg IV every 4 weeks (Q4W) or every 8 weeks (Q8W) in adults with UC or CD.

Results: 331 pts (UC=142; CD=189) were enrolled (VERSIFY=20; GEMINI LTS=311). Pts treated with VDZ in XAP had either dose frequency reduction Q4W to Q8W or were maintained on current Q8W or Q4W dosing; 297 started XAP on Q8W dosing, of which 295 received ≥1 VDZ dose in XAP. At XAP baseline, mean (SD) disease duration was UC: 13.9 (6.8) and CD: 13.2 (6.8) yrs; most pts were in clinical remission (Table 1). 283/295 pts (95.9%) were persistent on Q8W dosing for ≥6 months without relapse UC: 129/132 (97.7%) and CD: 154/163 (94.5%). Median (range) duration of VDZ treatment in XAP was UC: 3.8 (0–6) and CD: 4.2 (0–6) yrs. Only 27 pts (9.2%) were re-escalated from Q8W to Q4W dosing (UC: 11/132 [8.3%] and CD: 16/163 [9.8%]); median (range) duration from last dose in the qualifying study to dose escalation in XAP was UC: 1.5 (0.6-3.0) and CD: 1.2 (0.2–5.2) yrs; the corresponding duration from last dose in the qualifying study to relapse was 1.4 (0.4–4.0) and 1.2 (0.06–5.4) yrs. Adverse events (AEs) after enrolment into XAP occurred in 61.3% of pts with UC and 62.4% with CD (treatment-related in 2.1% UC and 4.2% CD), only 4.2% UC and 1.6% CD had AEs leading to study discontinuation (treatment-related: 0.7% UC, 0.5% CD); 13.4% UC and 16.4% CD had serious AEs (treatment-related: 0.7% UC, 0.5% CD). Severe infections occurred in 2 pts with UC (1.4% including 1 with COVID-19) and in 1 pt with CD (0.6%), none were considered treatment-related. There was 1 death from COPD.

Discussion: This long-term, prospective study reported high pt persistence on VDZ Q8W after the reduction of dosing frequency, together with low rates of dose frequency escalation to Q4W and relapse. Safety results were consistent with the known safety profile of VDZ; no new safety signal was identified.

Disclosures:

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.

Milan Lukas: Abbvie – Lecture Fees. Biogen – Lecture Fees. Bristol Mayer Squib – Consultant. Celltrion – Lecture Fees. Janssen – Lecture Fees. Pfizer – Lecture Fees. Sobi – Consultant. Takeda – Lecture Fees.

Miroslava Volfová indicated no relevant financial relationships.

Grażyna Rydzewska: AbbVie – Consultant, Lecture Fees. Alfa Sigma – Lecture Fees. Biocodex – Lecture Fees. Boehringer Ingelheim – Lecture Fees. Celltrion – Consultant, Lecture Fees. Ferring – Consultant, Lecture Fees. Johnson & Johnson – Consultant, Lecture Fees. Pfizer Inc – Consultant, Lecture Fees. Probi – Consultant. ProMed – Consultant, Lecture Fees. Sandoz – Consultant, Lecture Fees. Sanprobi – Lecture Fees. Takeda – Consultant, Lecture Fees.

Shashi Adsul: Takeda – Employee, Stock Options.

Dirk Lindner: Takeda – Employee, Stock Options.

Stephen Jones: Takeda – Consultant.

Séverine Vermeire: AbbVie – Consultant, Grant/Research Support. AbolerIS Pharma – Grant/Research Support. AgomAb – Grant/Research Support. Alimentiv – Consultant. Arena Pharmaceuticals – Consultant. AstraZeneca – Consultant. Avaxia Biologics – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. CVasThera – Consultant, Speakers Bureau. Cytoki Pharma – Consultant, Speakers Bureau. Dr. Falk Pharma – Consultant, Speakers Bureau. Eli Lilly – Consultant, Speakers Bureau. Ferring Pharmaceuticals – Consultant, Speakers Bureau. Galapagos – Consultant, Grant/Research Support, Speakers Bureau. Genentech/Roche – Consultant, Speakers Bureau. Gilead – Consultant, Speakers Bureau. GSK – Consultant, Speakers Bureau. Hospira – Consultant, Speakers Bureau. IMIDomics – Consultant, Speakers Bureau. Janssen Pharmaceuticals – Consultant, Speakers Bureau. Johnson & Johnson – Consultant, Grant/Research Support, Speakers Bureau. Materia Prima – Consultant, Speakers Bureau. MiroBio – Consultant, Speakers Bureau. Morphic – Consultant, Speakers Bureau. MRM Health – Consultant, Speakers Bureau. MSD – Consultant, Speakers Bureau. Mundipharma – Consultant, Speakers Bureau. Pfizer – Consultant, Grant/Research Support, Speakers Bureau. ProDigest – Consultant, Speakers Bureau. Progenity – Consultant, Speakers Bureau. Prometheus – Consultant, Speakers Bureau. Robarts Clinical Trials – Consultant, Speakers Bureau. Second Genome – Consultant, Speakers Bureau. Shire – Consultant, Speakers Bureau. Surrozen – Consultant, Speakers Bureau. Takeda – Consultant, Grant/Research Support, Speakers Bureau. Theravance Biopharma – Consultant, Speakers Bureau. Tillotts Pharma – Consultant, Speakers Bureau. Zealand Pharma – Consultant, Speakers Bureau.

Silvio Danese, MD, PhD¹, Milan Lukas, ², Miroslava Volfová, ³, Grażyna Rydzewska, ⁴, Shashi Adsul, MD, MBA⁵, Dirk Lindner, MSc⁶, Stephen Jones, ⁶, Séverine Vermeire, MD, PhD⁷. P3547 - Vedolizumab Long-Term Treatment Persistence and Safety – Results From a Multinational Extended Access Program Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.