1. Adherence Issues in IBD Sunanda Kane MD MSPH Professor of Medicine Mayo Clinic Rochester

2. Topics for Discussion Thoughts in this new era of practice Data from primary care Data on oral IBD meds Data on biologics (anti-TNF) Data on non-therapeutic areas

3. Perspective

4. Evidence  Practice Glasziou and Haynes ACP JC 2005

5. Where Are We? Educational intervention (1) Behavioral intervention (2) Cognitive behavioral intervention (1) – Altering thinking as well as other behaviors Multi-component interventions (6) None have been shown to increase adherence > 6 months Greenley R. Inflamm Bowel Dis 2013; 19:1534-1545

6. Primary Non-adherence with Prescriptions in Primary Care Canadian primary care network of 15,961 Primary non-adherence not filling an incident prescription within 9 months 31.3% of 37,506 prescriptions not filled Upper quartile of cost, those for dermatologic, gastrointestinal and autonomic conditions less likely to be filled compared with antibiotics Older age, co-pay coverage and more visits with MD protective of non-adherence Tamblyn R. Ann Intern Med 2014; 160:441-450.

7. Appearance Does Matter UnitedHealth database queried for medication use following MI 4573 single episodes of non-persistent medication use – OR if pill color changed 1.34 (1.12-1.59) – OR if pill shape changed 1.66 (1.43-1.94) These effects did not change even in multivariate analysis Kesselheim A et al. Ann Internal Med 2014; 161:96-103.

8. Burden of Comedications Polypharmacy of growing concern in chronically ill for several reasons IBD pts from Thomson Reuters MarketScan databases compared to HC – Narcotics 48% vs 34% – Non-narcotic analgesics 12.8% vs 8% – Antidepressants 28.3% vs 19.4% – Psychiatric meds 25.8% vs 16.7% Buckley J et al. Inflamm Bowel Dis 2013; 19(13):2725-2736.

9. Attitudes to Mesalamine Questionnaire Validation study of survey to predict non- adherence to mesalamine for UC Responses correlated with MMAS-8, MPR at 12 mo and urine levels of salicylates Patient belief in importance of maintenance when in remission and concerns about side effects were the 2 items that correlated best with all metrics Could be easily administered in clinic Moss A. Am J Gastroenterol 2014; Jun Epub ahead of print

10. Systematic Review of Adherence to Anti-TNF Therapy 13 studies identified 93,998 patients Pooled adherence 82.6% (range 37-96%) – Overall 83% for ADA – Overall 71% IFX Pts with CD > UC for either therapy Most reliable predictor of non-adherence was female gender, followed by smoking and psychological disease Lopez A. Inflamm Bowel Dis 2013; 19:1528-1533.

11. Strategies to Reduce Costs Associated with Biologic Use Eliminate Episodic Dosing Accurately Determine Indication for Escalating Dose Shorten Infusion Times What Still Needs to be Worked Out – SQ really cheaper? – Combination therapy – Monitoring drug levels – Do we really need complete mucosal healing? Park K. Inflamm Bowel Dis 2014; 20(5):946-51.

12. Self Efficacy Survey SE beliefs have significant effect on how a person will persist in performing a task over time, how much effort a person will expend and how engaged the person’s coping behavior when a skill is mastered Cannot do at all to Highly certain I can do 20-item survey for surveillance colonoscopy Refined survey 11 items, then 8 Adherence correlated well with all 3 surveys, accuracy was 74% Friedman S. Inflamm Bowel Dis 2014; 20:1602-1610.

13. Accept the news its time for procedure Schedule procedure Take the prep Tolerate the prep Avoid eating solid foods prior Drink enough clear fluids Recover from side effects Enjoy the rest of the day after procedure

14. Adherence and Efficacy of DEXA Screening for IBD Nationwide VA population: those exposed to steroids with IBD Of 5736 patients, 1.4% had fragility fx Adherence to AGA guidelines was 23% Those who had DEXA were half as likely to develop fragility fracture – HR 0.5 (0.3-0.9) Khan N. Am J Gastroenterol 2014: 109:572-78.

17. Summary Non-adherence prevalent Still no good, reliable, cheap way to change long-term behavior – Knowing this, take small frequent steps Not all meds have same issues Not all patients have same issues