inflammatory bowel disease drug therapy...
TRANSCRIPT
![Page 1: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/1.jpg)
David T. Rubin, MD, FACG
Inflammatory Bowel Disease Drug Therapy 2016
David T. Rubin, MD, FACGJoseph B. Kirsner Professor of Medicine
Chief, Section of Gastroenterology, Hepatology and Nutrition
Objectives
• Emphasize more recent changes in the approach to medical management of IBD
• Discuss basic principles of each class of therapy in IBD
• Provide optimization tips for each type of therapy
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 1 of 17
![Page 2: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/2.jpg)
David T. Rubin, MD, FACG
General Principles of IBD Management• We are treating the result of the IBD, not the cause (as far as
we know)- immune-based therapy
• Earlier is better
• Induction therapy usually dictates maintenance needs
• Severity of disease and burden of inflammation require more intensive therapy
• We are not curing IBDRubin DT, et al. Am J Gastroenterol. 2016; [Epub ahead of print].
Evolving Principles of IBD c.2016• Incorporate elements of prognosis into diagnosis and medical
decision making
• Moving beyond “one size fits all” to “smart therapy for the right patient”
• Precision medicine- optimization of treatments instead of “guesswork”
• Monitoring disease activity to achieve deeper remission and to anticipate flares
Rubin DT, et al. Am J Gastroenterol. 2016; [Epub ahead of print].
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 2 of 17
![Page 3: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/3.jpg)
David T. Rubin, MD, FACG
Drug Classes in IBD 2016
• Aminosalicylates– Oral– Rectal
• Corticosteroids– Systemic– Non-systemic– Rectal– Oral
• Immunomodulators– Thiopurines– Methotrexate
• Antibiotics
• Biologics– Anti-cytokines (Anti-TNF, Anti-IL12/23/6) – Anti-integrin (adhesion molecule
inhibitors)
• Investigational molecules– Janus kinase inhibitors– Anti-SMAD7 antisense oligonucleotide– Sphingosine-1-phosphate receptor
modulator
Aminosalicylates
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 3 of 17
![Page 4: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/4.jpg)
David T. Rubin, MD, FACG
General Principles of Aminosalicylates
• Effective for induction of mild to moderate UC (15-40%)
• Effective for maintenance of mild to moderate UC (58%-78%)
• Delivery-response relationship- get the drug to the location of the disease
• Very safe, but not completely safe (renal)1,2
• Affected by payers now- substitution required that is not bioequivalent
Hanauer SB, et al. Am J Gastroenterol. 1993;88:1188.Hanauer SB, et al. Am J Gastroenterol. 2005;100:2478.
Levine DS, et al. Am J Gastroenterol. 2002;97:1398.Sninsky CA, et al. Ann Intern Med. 1991;115:350.
1Van Staa TP, et al. Gastroenterology. 2004;126(7):1733–9.2Gisbert JP, et al. Inflamm Bowel Dis. 2007;13(5):629–38.
Ham M, Moss AC. Expert Rev Clin Pharmacol. 2012;5(2):113-23.Hanauer SB, et al. Ann Intern Med. 1996;124(2):204-11.
Pearls for Optimization of Aminosalicylates
• Don’t forget 3% of patients intolerant/allergic1
• Get the drug to the disease location
• Delivery systems may matter! If not responding, add or substitute a different delivery system2
• Dose reduction when deep remission obtained is usually safe3
1Kornbluth A, Sachar DB. Am J Gastroenterol. 2004;99(7):1371–85.2Harris MS, Lichtenstein GR. Aliment Pharamcol Ther. 2011;33(9):996-1009.
3Rubin DT, et al. J Crohns Colitis.2016;10(8):925-33.
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 4 of 17
![Page 5: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/5.jpg)
David T. Rubin, MD, FACG
Dose Reduction after Induction is Safe if there is Mucosal HealingMOMENTUM Trial
Rubin DT, et al. J Crohns Colitis.2016;10(8):925-33.
Induction (8 weeks)MMX mesalazine 4.8g/day
Maintenance (12 months)MMX mesalazine 2.4g/day
UC patients (n=717)
Corticosteroids
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 5 of 17
![Page 6: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/6.jpg)
David T. Rubin, MD, FACG
Corticosteroids
• Revolutionary discovery in IBD1
• Not sustainable
• Worst outcomes
• Prognostic- need for steroids dictates subsequent outcomes2
• Understand steroid-dependence
1Edwards FC, Truelove SC. Gut. 1963;4:299-215.2Faubion WA, et al. Gastroenterology. 2001;121(2):255-60.
Mor
talit
y (%
)
1938 –1952
1953–1962
1963–1972
1973–1982
1983–1987
40 Corticosteroids introduced in 1952
30
20
10
0
Ulcerative Colitis
Pearls for Optimization of Steroids
• Use non-systemic steroids first (also protects bones)1
• Have an exit strategy
• Don’t lose the forest for the trees (“what’s the harm of one more course of steroids?”)
• Don’t forget vitamin D, bone density1
1Schoon EJ, et al. Clin Gastroenterol Hepatol. 2005;3(2):113–21.
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 6 of 17
![Page 7: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/7.jpg)
David T. Rubin, MD, FACG
Why Do We Taper Steroids? Is There Evidence For It?
• Prevention of adrenal crisis or adrenal insufficiency– This is rare!– 5 mg or less does not seem to cause adrenal insufficiency– Higher doses are variable – 2 weeks of steroids unlikely to cause this
• Concern for disease relapse or “rebound”- no evidence
• Practical approach: taper over duration of induction period OR duration of time for maintenance therapy to work
LaRochelle GE Jr., et al. Am J Med. 1993;95(3):258-64.Streck WF, Lockwood DH. Am J Med. 1979;66(6):910-4.
Becker KB. Principles and Practice of Endocrinology and Metabolism. 3rd ed. Philadelphia, PA: J.B. Lippincott; 2001.Melmed S, et al. Williams Textbook of Endocrinology. 11th ed. Philadelphia, PA: Sauders;2007.
Immunomodulators
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 7 of 17
![Page 8: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/8.jpg)
David T. Rubin, MD, FACG
Thiopurines
• Genetically determined metabolism
• Steroid sparing
• Lymphoma risk well known (Schwartz)– HR 5.28 (95% CI, 2.0-13.9)1
– Back to baseline after stopping2
– Consider EBV testing for patients <20 yo 1Beaugerie L, et al. Lancet. 2009;374(9701):1617-1625.
2Khan N, et al. Gastroenterology. 2013;145(5):1007-1015.
AZA 6-MP HPRT
TPMT
6-TImP
DNARNA
Purinesynthesis
6-MMP
6-TU
XO
TPMT
Circulation Intracellular
6-MMPN
6-TGN
Early AZA Therapy is Not More Effective Than Placebo or Conventional Therapy for CD
Cosnes J, et al. Gastroenterology. 2013;145(4):758-65.
Actuarial probability of survival free relapse. Defined as CDAI >175 in patients treated with azathioprine and placebo.
n=63
Proportion of patients in corticosteroid-free remission per trimester over time. Concomitant proportions were significantly different only at trimester 3 (P<.05).
n=67
Panes J, et al. Gastroenterology. 2013;145(4):776-74.
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 8 of 17
![Page 9: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/9.jpg)
David T. Rubin, MD, FACG
Pearls for Optimization of Thiopurines
• No prospective data on optimization• Intermediate metabolizers do better!• Metabolites can be helpful1 (Siegel)
– Remember allopurinol2
• Bedtime or split dosing if nausea predominant• Pancreatitis is genetically determined too3
1Dubinsky MC. Curr Gastroenterol Rep. 2003;5(6):506-11.2Sparrow MP, et al. Clin Gastroenterol Hepatol. 2007;5(2):209-14.
3Ledder O, et al. Expert Rev Gastroenterol Hepatol. 2015;9(4):399-403.
Methotrexate
• Our colleagues are not as comfortable using it
• Effective for induction and maintenance of Crohn’s disease1
• Limited by toxicity/side effects2
• Relatively contraindicated in menstruating females
• No data for its use as salvage therapy after failing anti-TNF therapy
1Feagan BG, et al. N Engl J Med. 1995;332:292-297.2Patel V, et al. Cochrane Database Syst Rev. 2014;(8).
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 9 of 17
![Page 10: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/10.jpg)
David T. Rubin, MD, FACG
Pearls for Methotrexate
• Equal bioavailability PO up to 15 mg– ≥12.5 mg/w gives preferred outcomes in combination with anti-TNF
• Use ondansetron as a pre-med (30 minutes before MTX)
• Take it on weekends
• Don’t forget folic acid! (1-2 mg/day)
• Monitor liver enzymes every 6 months (but safe)1,2
1Te HS, et al. Am J Gastroenterol. 2000;95(11):3150-6.2Khan N, et al. Inflamm Bowel Dis. 2012;18(2):359-67.
Biologics
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 10 of 17
![Page 11: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/11.jpg)
David T. Rubin, MD, FACG
Anti-TNF Therapies for IBD
Modified from van Schouwenburg PA, et al. Nat Rev Rhematol. 2013;9(3):164-72.
CD CDUC
UCCDUC
Anti-TNF Biological Therapies
• Revolutionary in IBD
• Loading and maintenance needed
• Known risks of non-response or loss of response
• Important role for therapeutic drug monitoring (Siegel)
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 11 of 17
![Page 12: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/12.jpg)
David T. Rubin, MD, FACG
Pearls for Optimization of Anti-TNFs
• Routine assessment of stability between doses
• Understanding difference between class effect non-response and individual drug effect (swapping vs. cycling)
• Combination therapy mostly accepted as superior1,2
1Colombel JF, et al. N Engl J Med. 2010;362(15):1383-95.2Panaccione R, et al. Gastroenterology. 2014;146(2):392-400.
Higher Response and Remission Rates with Anti-TNFs in Patients with Shorter Disease Duration
• Infliximab for CD:– Pediatric response/remission = 90%/60%1
– Adult response/remission = 66%/39%2
• Adalimumab/certolizumab pegol for CD3,4:– Post-hoc– Shorter dz duration = better response
• Adalimumab maintenance3
– Less with shorter dz duration
• Claims data5
– Shorter time to anti-TNF = less time to surgery, steroids
1Hyams J, et al. Gastroenterology. 2007;132(3):863-73.2Hanauer S, et al. Lancet. 2002;359(9317):1541-9.
3Schreiber S, et al. J Crohns Colitis. 2013;7(3):213-21.4Sandborn W, et al. ACG. 2007.
5Rubin DT, et al. Inflamm Bowel Dis. 2012 Dec;18(12):2225-31.
0
20
40
60
100
58 80 104 140 164
80
Weeks from CHARM Baseline
Perc
ento
f Pat
ient
sin
Clin
ical
Rem
issi
on
<2 years, n=36≥2 to <5 years, n=63≥5 years, n=229
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 12 of 17
![Page 13: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/13.jpg)
David T. Rubin, MD, FACG
Biosimilars
• Inflectra, biosimilar to infliximab (Remicade), approved by the FDA on April 5th, 20161
• Amjevita, biosimilar to adalimumab (Humira) approved by the FDA on September 28th, 20162
• Infliximab biosimilar available in EU since 20133
1Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm. Accessed July 29 2016.2Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm. Accessed September 28 2016.
3European Medicines Agency. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001837.jsp&mid=WC0b01ac058004d5c1. Accessed July 29 2016.
• Several ongoing studies in Europe and Asia
• Evidence that unidirectional switches are safe1-7
• Still not available in the USA
• “Biosimilars are Here! What Every Gastroenterologist Needs to Know”– Tuesday, October 18th 11:30-11:50AM– Annual Scientific Meeting – 3B
1Park SH, et al. Expert Rev Gastroenterol Hepatol. 2015;9(Suppl1):35-44.2Kang YS, et al. Dig Dis Sci. 2015;60(4)951-6.
3Jung YS, et al. J Gastroenterol Hepatol. 2015;30(12):1705-12.4Gesce KB, et al. J Crohns Colitis. 2016;10(2):133-40.
5Smits LJ, et al. J Crohns Colitis. 2016. [Epub ahead of print].6Kolar M, et al. ECCO 2016. Abstract DOP032.
7Sieczkowska J, et al. J Crohns Colitis. 2016;10(2):127-32.
Biosimilars
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 13 of 17
![Page 14: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/14.jpg)
David T. Rubin, MD, FACG
Anti-integrins
Natalizumab Vedolizumab
Modified from van Schouwenburg PA, et al. Nat Rev Rheumatol. 2013;9(3):164-72.Rutgeerts P, et al. Gastroenterology. 2009;136(4):1182–97.
NatalizumabVedolizumab
300mg IV q4W 300mg IV at weeks 0, 2, and 6then 300 mg IV q8W
CD CDUC
Pearls for Anti-integrins• You still need to check for TB and HBV prior to insurance approval! (not because
of risk but because insurance companies are ignorant and require it)
• There are some patients who develop joint pain after starting therapy, unclear if this is:
– Side effect of medication– “uncovering” parallel joint problems in IBD patients that were otherwise treated with systemic
therapy– Withdrawal from steroids
• We have not had much difficulty getting dose escalation to monthly infusions– I have usually tried monthly infusions for 3-4 months before making a decision to stop trying this
mechanism
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 14 of 17
![Page 15: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/15.jpg)
David T. Rubin, MD, FACG
No Additional Benefit to Combination Therapy in Pivotal Trial of Vedolizumab
Colombel JF, et al. Gastroenterology. 2015;148(4):S277-8.
Clinical remission in Crohn’s Disease patients at week 6 by week 0 concomitant medication use: ITT Population
Where Should We Position Anti-Integrin Therapies?
• In patients unresponsive or intolerant to conventional therapies and anti-TNF agents
• In patients with unusual or other immune conditions such that additional systemic immune modification may be relatively contraindicated– Organ transplant patients– Hereditary or acquired immune deficiencies
• Other possibilities:– The older patient– Before systemic therapies?– Combination with calcineurin inhibitors
Christensen B, et al. Gastroenterology. 2015;148(4):S866.
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 15 of 17
![Page 16: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/16.jpg)
David T. Rubin, MD, FACG
• Approved by the FDA for moderate to severe Crohn’s disease on Sept 26, 2016
• Dose– Initial weight-based IV dose:
• ≤55 kg: 260 mg IV• >55 kg to 85 kg: 390 mg IV• >85 kg: 520 mg IV
– Maintenance dose:• 8 weeks after initial, 90mg SC q8w
Anti-IL 12/23 (Ustekinumab)
Brooks M. Medscape. http://www.medscape.com/viewarticle/869259. Accessed September 28, 2016.Medscape. http://reference.medscape.com/drug/stelara-ustekinumab-345050. Accessed September 29, 2016.
35.9%44.3%
29.8% 26.2%
49.0%*48.8%
*58.1%
*42.6% 38.6%
56.6%*53.1%
*59.4% *
46.9% 41.1%
*65.4%
0%
20%
40%
60%
80%
100%
Clinical Remission Clinical Response Steroid-Free Remission Remission in anti-TNF Failure Remission in anti-TNF Naïve
Week 44 Outcomes
Placebo (n=131) 90 mg Q12 weeks (n=129) 90 mg Q8 weeks (n=128)
1Sandborn W, et al. N Engl J Med. 2012;367(16):1519-28.2Sandborn W, et al. Presented at DDW, May 2016. Oral Presentation 768.
Phase 3 Maintenance Study in CD2
Ustekinumab (anti-IL12/23) for Moderate to Severe CD
• Effective for induction with clinical response rates at week 6 compared to placebo (23.5%)1
– 36.6% (1mg/kg)– 34.1% (3mg/kg)– 39.7% (6mg/kg)
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 16 of 17
![Page 17: Inflammatory Bowel Disease Drug Therapy 2016s3.gi.org/acgmeetings/2016/pgsyllabus/2016PG_FINAL_0006.pdf · Title: Microsoft PowerPoint - RUBIN ACG 2016 - IBD Drug Therapy.FINAL 3.pptx](https://reader031.vdocuments.us/reader031/viewer/2022013015/5b271bb27f8b9ab2768b476d/html5/thumbnails/17.jpg)
David T. Rubin, MD, FACG
Safety of Ustekinumab Through 44 WeeksIM-UNITI
• No notable new safety issues identified• No deaths or serious opportunistic infections• 2.3% of patients developed antibodies, but these did not preclude drug efficacy
Subjects With (%) Placebo 90 mg SC Q12w 90 mg SC Q8w
Death 0% 0% 0%
AEs 83.5% 80.3% 81.7%
Serious AEs 15.0% 12.1% 9.9%
Serious Infections 2.3% 5.3% 2.3%
Discontinuation due to AE 6.0% 7.6% 3.1%
Malignancies 0.8% 0% 0.8%AE, adverse event; Q8w, every 8 weeks; Q12w, every 12 weeks
Sandborn W, et al. Presented at DDW May 2016. Oral Presentation 768.
Summary: IBD Drug Therapy 2016• Goals of management are evolving: use prognosis, target deep remission.
• For 5-ASAs understand delivery and possible dose-reduction in maintenance.
• You don’t need to taper steroids as much as you think.
• Lymphoma is from thiopurines, goes away when these drugs are stopped.
• Pro-active anti-TNF drug monitoring is coming soon.
• Biosimilars are coming soon… Interchangeability is uncertain.
• Anti-integrin therapies are safe and probably should be used earlier, at least in UC.
• Anti-IL12/23 is shown to be effective in induction and maintenance of moderate-to-severe CD as maintenance therapy.
ACG 2016 Annual Postgraduate Course Copyright 2016 American College of Gastroenterology
Page 17 of 17