An Update on the Biologic Treatment for Patients with Inflammatory Bowel Disease. David A. Schwartz, MD

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1 An Update on the Biologic Treatment for Patients with Inflammatory Bowel Disease David A. Schwartz, MD Director, Inflammatory Bowel Disease Center Associate Professor of Medicine Vanderbilt University Medical Center Overview Crohn s Disease Outline Current Biologic Treatment Options Earlier Treatment How to Treat Loss of Response Ulcerative Colitis Current Biologic Treatment Options What s on the Horizon? 1

2 FDA-approved biologics for IBD Crohn s Disease Anti-TNF antibodies Adalimumab (Humira ) Certolizumab pegol (Cimzia ) Infliximab (Remicade ) Ulcerative Colitis Anti-TNF antibodies Adalimumab (Humira ) Infliximab (Remicade ) Selective adhesion molecule Natalizumab (Tysabri ) Case #1 2

3 28 yo with Refractory Disease 28 yo male comes to office for 2 nd opinion with 6 year hi t f C h il liti history of Crohn s ileocolitis. He has abdominal pain and diarrhea (1-12x / day) with urgency and 1# wt loss. He on 2.5 mg /kg/day of azathioprine and 4 grams of mesalamine He is a non-smoker No previous h/o surgery 28 yo with Refractory Disease (Part B) On exam he looks thin, afebrile. Tender to palpation in RLQ. HR is 1 Labs: WBC= 1k, Hgb 11, Plt 6, CRP 2 Stool studies negative 3

4 28 yo with Refractory Disease (Update) Colonoscopy shows ulcerations, friability, and muco - purulence involving the whole colon. There is also active ileitis. CTE: Active ileitis in distal 8 cm without stricture Lab testing CRP 2 6-TG 3, 6-mmp 58 What should you do now? FDA Approved Anti-TNFs 4

5 Comparison of Anti-TNF Maintenance Trials SONIC: Clinical Remission Without Steroids: Week 26 Propo ortion of Patients (%) p<.1 p=.9 p= /17 75/169 96/169 AZA + placebo IFX + placebo IFX+ AZA Colombel JF, et al. N Engl J Med 21;362(15):

6 28 yo with Refractory Disease: Update Patient is started on an anti-tnf and continues azathioprine. Does well initially but develops symptoms again 1 year later. 4-6 stools per day with urgency. No blood in stool noted. On exam he looks well, afebrile. Labs: WBC= 7k, Hgb 14, Plt 5, CRP 15 Stool studies negative What do you do now? In other words, how do you handle loss of response High Infliximab Levels are Associated with Mucosal Healing in Crohn s Disease Serum samples in 21 CD patients undergoing treatment with infliximab were collected Infliximab trough levels were correlated with endoscopic healing (complete, partial or none) rough level (mcg/ml) Tr Complete Partial None Van Moerkercke et al. Van Moerkercke W, et al. DDW 21. Abs #45b 6

7 SONIC: Clinical Remission Without Corticosteroids Primary Endpoint 1 By Trough IFX Concentration at Week Patients (%) /32 13/23 43/59 36/49 31/43 >-1 >1-3 >3-6 >6 IFX Concentration (mg/ml) at Week 3 Colombel JF, et al. N Engl J Med 21;362(15): Measurement of IFX Levels and ATIs Test results impacted treatment in 73 % of patients N=155 Subtherapeutic IFX Dose escalation Complete or partial response - 86% Subtherapeutic IFX Switch anti-tnf Response - 33% Therapeutic IFX No evidence of active inflammation in 62% of the patients ATIs + patients Switch anti-tnf Response - 92% ATIs + patients Dose escalation Response - 17% Increasing the infliximab dose in patients who have HACAs is ineffective, whereas in patients with subtherapeutic infliximab concentrations, this strategy may be a good alternative to changing to another anti-tnf agent. Afif W, et al. Am J Gastroenterol. 21;15(5):

8 Response and Remission Rates in PRECiSE 4 Sandborn WJ et al. Gastroenterology. 27;132(suppl 1):A55. Micro-Reinduction with Adalimumab for loss of response Changed or discontinued Anti-TNF 18% % % Remained on same Anti- TNF 82% N=87 Pts given 8 mg x 2 doses Ligler, Schwartz et al. Advances 211 8

9 Switching to Another TNF Adalimumab for IFX Failures at Wk 4 Certolizumab pegol for IFX Failures at Wk 6 (open label) Pts, % 6 52 *** ** *** Remission CR7 CR1 Response (CR7) Response (CR1) Remission CDAI <15 _ 1- Sandborn, Ann Int Med Sandborn, Clin Gastro Hep Mechanism of Action- Natalizumab 9

10 Induction of Remission with Natalizumab: ENCORE* Trial * All randomized patients (secondary end point). **P.11 vs placebo. Patients (%) ** 24 Placebo 21 ** 32 Natalizumab 25 ** ** 26 Week 4 Week 8 Week 12 Weeks 8 & 12 Targan et al. Gastroenterology. 27;132: Maintenance of Remission with Natalizumab 1

11 Natalizumab and Risk of PML ~ 99,6 pts have received natalizumab 264 cases of progressive multifocal leukoencephalopathy (PML) Only 2 case with CD (1 in clinical trial, 1 post-trial after 35 doses) All PML cases > 8 months of natalizumab therapy Rate approximately 2.36 per 1 treated patients Bloomgren G. N Engl J Med 212;366(2): yo with Refractory Disease: Final What happened with our patient? Infliximab levels checked: IFX trough < 1mcg / ml ATI 29 U/ml Patient switched to a 2 nd Anti-TNF. Got induction dosing and recaptured remission. 11

12 Case #2 35 yo with Mod Severe UC 35 yo male comes to office with a 2 year history of UC. Currently on 4.8 g/day of oral Mesalamine and 2.5 mg /kg/day of azathioprine. He has had intermittent symptoms since diagnosis Comes in now with abdominal pain and bloody diarrhea (12-15x / day) with urgency and 1# wt loss. Fever to 11 Started on prednisone 4 mg a day 2 weeks ago by pcp 12

13 UC Patient (Part B) On exam he looks ill, afebrile. Tender to palpation in LLQ. HR is 11 Labs: WBC= 15k, Hgb 11, Plt 6 Stool studies negative Colonoscopy shows ulcerations, friability, and muco - purulence involving the whole colon. The ileum is normal. CTE: no small bowel disease So what do you do now? CyA vs Infliximab in IV Steroid- Refractory UC: The CYSIF Study Conclusion: CyA is not more effective than infliximab in achieving short-term remission and avoiding urgent colectomy in IV steroid-refractory acute UC Response Rates at Day 7 N=111 (55 CyA; 56 IFX) nts (%) Patie 1 84% 86% CyA Infliximab Laharie D et al. Lancet 212;38:p

14 Infliximab for UC: Clinical Remission at Week 3 (%) Proportion of Patients ACT 1 ACT 2 Placebo infusions 5 mg/kg Infliximab 1 mg/kg Infliximab Rutgeerts P, N Engl J Med 25;353: UC Success - Week 16 Results Patients (%) 12 AZA n=76 IFX n=77 1 IFX+AZA n=76 # 8 # # # 5. * 4 # Steroid-free remission Response Mucosal healing Paccionne. Gastroenterology 211;14 (5 Suppl 1):S134 *p<.5 compared to IFX #p<.5 compared to AZA 14

15 ADA for UC (ULTRA) - Results Sandborn et al, Gastro 212;142: *p= yo with UC: Final What happened with our patient? Started on Infliximab. Continued on 5-ASA and azathioprine Improved and was able to taper off steroids by week 8 and remain in remission 15

16 What is on the Horizon? Golimumab for UC 6 Week 6 Results 5 N=774 *P= * 52* Golimumab 4mg / 2mg Golimumab 2mg / 1mg Placebo * 19* Remission 6 Response 16

17 Patients (%) Ustekinumab in CD Results: Primary endpoint was clinical response at week 6 + p<.5 vs PBO by CMH test 5 *Primary Endpoint + Placebo mg/kg mg/kg mg/kg UST combined Response* Remission Response Remission Week 6 Week 8 Ustekinumab in CD Results All UST doses had significant changes in CDAI scores, CRP, fecal lactoferrin and calprotectin, and IBDQ vs. placebo at wk 6 Patients (%) p= Placebo UST SC p< Response Remission Maintenance, Week 22 17

18 Vedolizumab for UC 6 5 Week 6 Results N=374 * P<.1 ** P =.1 4 % * 53 Vedo Anti-TNF Naïve - Vedo Placebo ** 23 5 Remission Response Vedolizumab for CD Week 52 ITT Results *P< **P< ** 39** 22 46** 44* 3 VDZ Q4wks VDZ Q8wks Placebo 5 Remission Response 18

19 Thank you for your time! 19

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