New treatment options in IBD: today and the future. Silvio Danese Istituto Clinico Humanitas, Milan, Italy
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1 New treatment options in IBD: today and the future Silvio Danese Istituto Clinico Humanitas, Milan, Italy Date of preparation: October 2014 GLO/EYV/ h
2 Overview of the late-stage IBD drug pipeline* Anti-Smad7 Anti-MAdCAM-1 Anti-IP-10 Stem cells Anti- α E β 7 IL inhibitors Anti-α 4 β 7 Anti-α 4 Anti-TNFα Biologics Phase II Phase III Pre-reg Launched Small molecules Anti-α 4 JAK inhibitors Anti-CCR-9 *Some classes of drugs are not yet approved/licensed CCR-9, chemokine receptor 9; IBD, inflammatory bowel disease; IL, interleukin; IP-10, Interferon-γ-inducible protein-10; JAK, Janus kinase; MAdCAM-1, mucosal vascular addressin cell adhesion molecule 1; Pre-reg, pre-registration; TNF, tumour necrosis factor Adapted from: Danese S. Gut 2012;61: ; Danese S, Panés J. Gastroenterology 2014; Epub 14 September (DOI: /j.gastro ). 2
3 Gut selectivity: a key to therapeutic success α L β 2 α M β 2 α 4 β 7 α 4 β 1 α L β 2 α M β 2 α 4 β 7 α 4 β 1 ICAM-2 ICAM-1 MAdCAM-1 VCAM-1 Natalizumab, AJM300 ICAM-2 ICAM-1 MAdCAM-1 VCAM-1 Vedolizumab, AMG 181, etrolizumab, PF ICAM, intercellular adhesion molecule; MAdCAM-1, mucosal vascular addressin cell adhesion molecule-1; VCAM-1, vascular cell adhesion molecule-1 Danese S, Panés J. Gastroenterology 2014; Epub 14 September (DOI: /j.gastro ). 3
4 GEMINI I: vedolizumab in UC Maintenance phase: outcomes at Week 52 Primary outcome: maintenance ITT population Patients (%) Adjusted difference, percentage points (95% CI) VDZ Q8W vs. PBO VDZ Q4W vs. PBO p<0.001 p< Clinical remission 26.1 (14.9, 37.2) 29.1 (17.9, 40.4) 44.8 VDZ/PBO (n=126) VDZ Q8W (n=122) VDZ Q4W (n=125) CI, confidence interval; ITT, intent to treat; PBO, placebo; Q4W, every 4 weeks; Q8W, every 8 weeks UC, ulcerative colitis; VDZ, vedolizumab Adapted from: Feagan BG, et al. N Engl J Med 2013;369:
5 GEMINI I: vedolizumab in UC Key safety results Incidence, n (%) Combined PBO Combined VDZ (n=275) (n=620) Any AE 220 (80) 497 (80) Serious AE 37 (13.5) 77 (12.4) Common AEs in 10% UC exacerbation 58 (21.1) 97 (15.6) Headache 28 (10.2) 80 (12.9) Nasopharyngitis 26 (9.5) 80 (12.9) Arthralgia 25 (9.1) 56 (9.0) Upper respiratory tract infection 21 (7.6) 52 (8.4) Nausea 19 (6.9) 38 (6.1) Cough 13 (4.7) 36 (5.8) Anaemia 16 (5.8) 35 (5.6) Abdominal pain 10 (3.6) 35 (5.6) Fatigue 10 (3.6) 33 (5.3) Influenza 6 (2) 30 (5) Infections 155 (56) 371 (60) Serious infection 8 (2.9) 12 (1.9) Malignant neoplasm 3 (1.1) 1 (0.2) AE, adverse event; PBO, placebo; UC, ulcerative colitis; VDZ, vedolizumab Feagan BG, et al. N Engl J Med 2013;369:
6 GEMINI II: vedolizumab in CD Maintenance phase: outcomes at Week 52 Patients (%) Mean % VDZ vs. VDZ/PBO Primary outcome p=0.004 p< Maintenance ITT population p=0.005 p= Secondary outcomes p=0.04 p= Clinical remission CDAI-100 response GC-free remission Durable remission CD, Crohn s disease; CDAI, Crohn s Disease Activity Index; GC, glucocorticoid; ITT, intent to treat; PBO, placebo; VDZ, vedolizumab Adapted from: Sandborn WJ, et al. N Engl J Med 2013;369: VDZ/PBO (n=153) VDZ Q8W (n=154) VDZ Q4W (n=154)
7 GEMINI II: vedolizumab in CD Maintenance phase: key safety results VDZ induction responders VDZ induction Incidence, n (%) VDZ/PBO VDZ Q8W VDZ Q4W Non-responders PBO/PBO (n=153) (n=154) (n=154) (n=506) (n=148) Any AE 128 (84) 135 (88) 130 (84) 441 (87) 118 (80) Serious AE 23 (15) 28 (18) 25 (16) 146 (29) 23 (16) Common AEs in 10% Crohn s disease 29 (19) 25 (16) 24 (16) 115 (23) 36 (24) Abdominal pain 18 (12) 15 (10) 19 (12) 45 (9) 21 (14) Nausea 18 (12) 18 (12) 22 (14) 50 (10) 12 (8) Upper respiratory tract infection 29 (19) 35 (23) 43 (28) 106 (21) 27 (18) Arthralgia 21 (14) 17 (11) 21 (14) 72 (14) 19 (13) Pyrexia 23 (15) 18 (12) 29 (19) 56 (11) 17 (11) Headache 28 (18) 20 (13) 26 (17) 51 (10) 19 (13) Infections 64 (42) 69 (45) 71 (46) 219 (43) 57 (39) Serious infection 5 (3) 6 (4) 9 (6) 30 (6) 4 (3) Infusion reaction 6 (4) 7 (5) 10 (6) 16 (3) 8 (5) Malignant neoplasm 0 (0) 1 (<1) 0 (0) 3 (<1) 1 (<1) AE, adverse event; CD, Crohn s disease; PBO, placebo; VDZ, vedolizumab Sandborn WJ, et al. N Engl J Med 2013;369: (Supplementary appendix: Table S6). 7
8 Conclusions We have a new class of drug in our therapeutic armamentarium! Vedolizumab provides us with a new option for the first-line biologic treatment of ulcerative colitis and Crohn s disease Vedolizumab can also be used as a second-line biologic in patients who have not responded to, or are intolerant to TNFα inhibitors Safety and tolerability reflect gut-selective mechanism of action Vedolizumab will be a valuable addition for prescribers and patients to consider when they fail conventional therapy TNFα, tumour necrosis factor alpha 8
9 Clinical positioning of current biologics Anti-TNFα Anti-integrin Ulcerative colitis Induction / maintenance UC / / Steroid-refractory fulminant UC Steroid-refractory UC (post-hoc) Early UC / Late UC (post-hoc) Safety in UC Crohn s disease Induction / maintenance luminal CD / / Perianal fistulising CD Infliximab Early luminal / Late luminal CD (post-hoc) / / Favourable efficacy and/or safety profile Less favourable profile CD, Crohn s disease; IBD, inflammatory bowel disease; UC, ulcerative colitis Danese S, Panés J. Gastroenterology 2014; Epub 14 September (DOI: /j.gastro ). 9
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