Choosing and Positioning Biologic Therapy for Crohn s Disease: (Still) Looking for the Crystal Ball
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1 Choosing and Positioning Biologic Therapy for Crohn s Disease: (Still) Looking for the Crystal Ball Siddharth Singh, MD, MS Assistant Professor of Medicine Division of Gastroenterology Division of Biomedical Informatics University of California San Diego La Jolla, California e sis040@ucsd.edu UCI Las Vegas, NV November 9, 2018
2 Objectives 1. Comparative efficacy of biologics for CD 2. Comparative safety of biologics 3. Speed of onset of action 4. Predictors of response
3 A pledge before we begin 1. I will OBJECTIVELY CONFIRM presence of inflammation in my patients with CD before any treatment change 2. I will OBJECTIVELY CONFIRM resolution of inflammation after any treatment initiation before declaring success 3. I will OPTIMIZE my index biologic before conceding failure 4. I will NOT RESORT to chronic corticosteroids or narcotics to help myself or the patient, or to avoid difficult conversations 5. I will clearly and objectively discuss RISKS with biologic therapies with my patients (rather than let the Internet discuss)
4 Comparative Efficacy of Different Biologics in Crohn s Disease
5 Biologics for Moderate-Severe CROHN S DISEASE Danese, et al. Nat Rev Gastroenterol Hepatol 2015:12:537
6 Efficacy of biologics in CROHN S DISEASE Biologic-naïve patients Clinical Remission with Induction therapy (%) Infliximab Adalimumab Certolizumab pegol Vedolizumab Ustekinumab
7 Mixed effect estimate Combines direct evidence (head-to-head trials) AND indirect evidence (common comparator), for all interventions Mills, et al. JAMA 2012;308:1246; Capriani et al. Ann Intern Med 2013;159:130; Singh S. Clin Transl Gastroenterol 2017;8:e93
8 Comparative Efficacy: First-line Therapy for Induction of Remission Drug Odds Lower Upper ratio limit limit SUCRA ranking Odds ratio and 95% CI Infliximab Adalimumab Certolizumab Pegol Vedolizumab Ustekinumab Singh, et al. Aliment Pharmacol Ther 2018
9 Comparative Efficacy: Maintenance of Remission (among Responders to Induction therapy) Drug Odds ratio Odds Lower Upper SUCRA and 95% CI ratio limit limit ranking Infliximab Adalimumab Certolizumab Pegol Vedolizumab Ustekinumab Singh, et al. Aliment Pharmacol Ther 2018
10 Estimated Rates of INDUCTION and MAINTENANCE of Remission FIRST-LINE Crohn s Disease Agent Induction of Clinical Remission Maintenance of Clinical Remission Placebo 16% 22% Infliximab Adalimumab Certolizumab pegol Vedolizumab Ustekinumab GRADE Quality of Evidence Singh, et al. Aliment Pharmacol Ther 2018
11 Estimated Rates of INDUCTION and MAINTENANCE of Remission FIRST-LINE Crohn s Disease Agent Induction of Clinical Remission Maintenance of Clinical Remission GRADE Quality of Evidence Placebo 16% 22% - Infliximab [Low] Adalimumab [Moderate] Certolizumab pegol [Low] Vedolizumab [Moderate] Ustekinumab [Moderate] Singh, et al. Aliment Pharmacol Ther 2018
12 Estimated Rates of INDUCTION of Clinical Remission SECOND-LINE Crohn s Disease Agent Induction of Clinical Remission SUCRA Ranking Probability GRADE Quality of Evidence Placebo 9% 0% - Adalimumab* 25 91% [Low] Vedolizumab 12 35% [Moderate] Ustekinumab 19 71% [Low] *Adalimumab was selectively studied in patients with PRIOR RESPONSE to infliximab who then develop secondary loss of response or intolerance; patients with primary non-response to infliximab were excluded Singh, et al. Aliment Pharmacol Ther 2018
13 Anticipated Head-to-Head Trials 1. Ustekinumab vs. Adalimumab (SEAVUE NCT ) 52-week trial, 350 patients; Double-blind, double-dummy Anticipated completion December Brazikumab (anti-il23) vs. Adalimumab vs. placebo 52-week trial, patients; double-blind, doubledummy, placebo and active comparator controlled Anticipated completion December Standard vs. high-dose Adalimumab (SERENE CD) Compares standard ADA dose (160/80) vs. higher induction dose, and standard vs. higher vs. TDM-guided maintenance 52-week trial, 940 patients
14 Real-world/Observational Comparative Effectiveness Studies
15 Population-based, propensity score-matched cohort study Denmark, Biologic-naïve patients with CD 2908 biologic-naïve patients with CD, between ages >6 months No prior anti-tnf prescription Baseline Patients with CD treated with anti- TNF ( ) Follow-up Outcomes Hospitalization Surgery New steroid prescriptions Serious infections Singh, et al. Aliment Pharmacol Ther 2018
16 Infliximab vs. Adalimumab for Crohn s disease Patient-relevant outcomes after starting index anti- TNF agent All-cause hospitalization CD-related hospitalization Major abdominal surgery Events per 100 Patient-Yrs (Propensity-score matched) IFX (n=315) ADA (n=512) Effectiveness Outcomes Hazard ratio (95% CI) (IFX vs. ADA as reference) ( ) ( ) ( ) Steroid prescription ( ) Safety Outcomes Serious infection ( ) Singh, et al. Aliment Pharmacol Ther 2018
17 All-cause hospitalization aor, 0.70 ( ) CD-related hospitalization aor, 0.59 ( ) CD-related surgery aor, 0.75 ( ) Steroid use aor, 0.91 ( ) Infliximab vs. Certolizumab pegol for Crohn s disease Singh, et al. Clin Gastroenterol Hepatol 2018
18 Dulai, et al. ECCO 2018, personal communication Vedolizumab vs. Anti-TNF Agents in CD: VICTORY Consortium Propensity score-matched, retrospective cohort study VICTORY Consortium, 16 sites across US 1200 patients, 1:1 for vedolizumab vs. anti-tnf; consecutive patients initiated on biologic at individual sites since 2014 Overall (Vedo vs. anti-tnf) Anti-TNF-naïve Anti-TNF-exposed Clinical remission 0.92 ( ) 0.92 ( ) 0.97 ( ) Steroid-free clinical remission Endoscopic remission 1.26 ( ) 2.53 ( ) 1.57 ( ) 1.31 ( ) 0.86 ( ) 1.04 ( )
19 Overall and Comparative Safety of Biologic Therapy in IBD Serious infections Malignancy risk, especially lymphoma
20 10.5/1000py /1000py Kirchgesner et al. Gastroenterology 2018;155:337
21 Risk Factors for Serious and/or Opportunistic Infections in Anti-TNF-treated Patients 2,226 ADA-treated patients from clinical trials; 35y, 60% females 47% on concomitant immunomodulators, 39% on steroids; 27% with fistulae Risk of serious infection Risk factors* HR 95% CI 100-point increase in CDAI ADA+Immunomodulator vs. ADA ADA + Corticosteroids vs. ADA *Similar results if limited to non-cd-related serious infections, or opportunistic infections TREAT Registry, Infliximab Risk factors for DEATH prednisone (HR, 2.1), narcotic use (HR, 1.8) and age (HR, 1.1) Risk of serious infection Risk factors* Moderate-severe disease activity Underlying DISEASE ACTIVITY and Corticosteroid use is associated with increased risk of infections HR (95% CI) 2.24 ( ) Narcotic analgesics 1.98 ( ) Prednisone therapy 1.57 ( ) Infliximab 1.43 ( ) Osterman, et al. Am J Gastroenterol 2016;111:1806; Lichtenstein, et al. Am J Gastroenterol 2012;107:1409
22 Disease-related risk factors for serious Type of infection infections in IBD Rate per 10,000 pt-yrs all patients Pneumonia 17 Abdominal abscess 9 Catheter sepsis 9 MODERATE TO SEVERE ACTIVITY = strongest predictor of serious infection (HR 2.2) Sepsis 7 Cellulitis 6 Central line infection 6 Perirectal abscess 5 Pelvic abscess 5 Intestinal abscess 4 Wound infection 3 Postoperative abscess 2 Inadequate disease control is a KEY risk factor for infections Lichtenstein et al. Am J Gastroenterol, 2012.
23 Potentially preventable infections Type of infection Rate per 10,000 pt-yrs all patients Pneumonia 17 Abdominal abscess 9 Measures where we can improve care for the hospitalized patient? 1. Improving nutritional status pre-op 2. Removing indwelling catheters as early as possible 3. Close monitoring of wound sites post-op 4. Incentive spirometry 5. Appropriate steroid tapering pre- & post-op Catheter sepsis 9 Sepsis 7 Cellulitis 6 Central line infection 6 Perirectal abscess 5 Pelvic abscess 5 Intestinal abscess 4 Wound infection 3 Postoperative abscess 2
24 44 trials of biologic agents; 14,032 patients Serious infection: 2.1% Anti-TNF vs. anti-integrin Safety Outcome Odds Ratio 95% CI Serious infection Opportunistic infection ANY infection Malignancy
25 Comparative safety Anti-TNF agents vs. Vedolizumab Vedolizum ab Anti-TNF Odds Ratio 95% CI Serious Infections 4.1% 10.1% Serious Adverse Events Serious Infections Serious Adverse Events 4.7% 14.5% Vedolizuma b Biologic Monotherapy Biologic + Steroids + Immunomodulator Anti-TNF Odds Ratio 95% CI 11.5% 13.9% % 14% Vedolizumab monotherapy is associated with lower risk of serious infections vs. anti-tnf monotherapy But safety advantage lost when used in combination Dulai, et al. ECCO 2018
26 Comparative safety Anti-TNF agents vs. Prolonged Corticosteroids Lewis, et al. Am J Gastroenterol 2018;113:405 Lower risk of death, major adverse cardiovascular events, fractures in anti-tnf-treated patients vs. long-term corticosteroids, without an increase in risk of serious infections
27 Anti-TNF therapy is NOT associated with increased risk of cancer in patients with IBD Nyboe Andersen, et al. JAMA 2014;311:2406
28 Thiopurine monotherapy and anti-tnf monotherapy may be associated with increased risk of lymphoma in patients with IBD and risk is highest with combination therapy Kirchgesner et al. Gastroenterology 2018;155:337
29 What risks are our PATIENTS willing to take? Discrete choice experiment, in 202 patients with IBD (70% in remission) To avoid disease relapse over next 5 years, patients are willing to accept a 28% chance of serious infection, and 1.8% chance of lymphoma Bewtra, et al. Am J Gastroenterol 2015;110:1675
30 Overall and Comparative Efficacy and Safety of Different Biologics Agents 1. Anti-TNF agents (infliximab, adalimumab) are the most-effective first-line agents for Crohn s disease 2. Ustekinumab (anti-il12/23) is probably the most effective secondline agent for Crohn s disease, especially in patients with primary non-response to anti-tnf agents 3. Combination therapy (biologic + immunomodulators ± corticosteroids) carries highest risk of infection, followed by anti- TNF monotherapy 4. Uncontrolled disease, needing repeated corticosteroids, probably carries highest risk of infections; achieving and maintaining corticosteroid-free remission is safest 5. Combination therapy, as well as monotherapy with thiopurines and anti-tnf agents, is associated with increased risk of lymphoma 6. Limited data on comparative safety of newer non-tnf biologics
31 Speed of Onset of Action
32 Anti-TNF agents and ustekinumab Anti-TNF agents and ustekinumab have a rapid onset of action in patients with CD Hanauer, et al. Gastroenterology 2017; Feagan, Sandborn, et al. N Engl J Med 2016;375:1946
33 Vedolizumab for Crohn s Disease Vedolizumab has relatively rapid onset of clinical in biologic-naïve patients vs. anti-tnf exposed patients Predictors of symptomatic improvement by week 2 low CDAI, disease duration <2y and concomitant corticosteroids Feagan, et al. Clin Gastroenterol Hepatol 2019
34 Predictors of Response to Biologic Therapy
35 Predictors of Failure of Anti-TNF agents (and probably all biologic agents) Clinical Factors Pharmacokinetic Factors Disease duration >2y Penetrating and perianal disease Prior surgery Smoking Low albumin High inflammatory burden Male sex High body mass index Predicted probability of being a primary non-responder to infliximab Ding, et al. Aliment Pharmacol Ther 2015; Billient, et al. J Crohns Colitis 2015
36 Clinical Prediction Tool for Vedolizumab in Crohn s Disease Dulai, et al. Gastroenterology 2018:155:687
37 Ustekinumab for Crohn s Disease Induction of Remission Anti-TNF-failure Anti-TNF-naïve Feagan, Sandborn, et al. N Engl J Med 2016;375:1946
38 My Approach to Choosing Biologics in CD Favor infliximab or adalimumab Extensive small bowel disease Internal penetrating disease (after source control in patients with intra-abdominal abscess) Perianal disease High inflammatory burden Favor ustekinumab Severe disease in setting of active or recent malignancy (particular hematological malignancies) Associated psoriasis or cutaneous complications Preferred second-line agent for most patients with CD Favor vedolizumab Moderate disease, with low-risk phenotype in riskaverse patients Moderate disease in setting of active or recent malignancy Moderate disease in setting of multiple comorbidities Post-operative prophylaxis Prominent extra-intestinal manifestations
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