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Clinical Management and Adherence Issues in IBD Illness-Related Factors Affecting Adherence in IBD Severity, extent, duration of disease Frequency, duration, intensity of flare-ups Type and severity of complications Patients with well-controlled disease and few flares are most likely to discontinue maintenance therapy Treatment-Related Factors Affecting Adherence in IBD Convenience – Dosage/dosing regimen – Formulation – Method of administration – Pill size Cost/reimbursement Choice of medication – Sulfasalazine, corticosteroids • Need to balance efficacy vs safety • Start with low doses, titrate slowly upward – Mesalamine • Dose-related efficacy but not toxicity • Initiate and maintain treatment with high doses • Induction dose = maintenance dose Patient-Related Factors Affecting Adherence 1Martin Inadequate education1; inadequate skills/knowledge to follow regimen2 Patients’ main concerns – Uncertain nature of IBD – Effects of medications3 Patients’ belief systems (treatment will not help, side effects outweigh benefits)2 Psychiatric disorders4 Male, unmarried, younger age5,6 Patterns of nonadherence7 A, et al. Ital J Gastroenterol. 1992;24:477-480. 2Levy RL, Field AD. Am J Gastroenterol. 1999;94:1733-1742. 3Drossman DA, et al. Psychosom Med. 1991;53:701-712. 4Nigro G, et al. J Clin Gastroenterol. 2001;32:66-68. 5Kane S. Am J Gastroenterol. 2001;96:2929-2932. 6Kane S. Am J Gastroenterol. 2001;96(suppl):S296. 7Kane S. In: Bayless TM, Hanauer SB, eds. Advanced Therapy of Inflammatory Bowel Disease. Hamilton, Ontario: BC Decker, 2001:9-11. Prevalence of Nonadherence to IBD Maintenance Therapy 1Blackwell Failure to take medication by patients with other illnesses: 25%–50%1 41% of patients on maintenance sulfasalazine do not take prescribed dosages2 Clinical research protocols overestimate drug adherence B. Clin Pharmacol Ther. 1972;13:841-848. 2van Hees PAM, van Tongeren JHM. J Clin Gastroenterol. 1982;4:333-336. Impact of Nonadherence on Outcomes in IBD % of Patients With Quiescent UC Remaining in Remission 100 90 Adherent to 5-ASA therapy (Asacol®) 80 70 60 Nonadherent to 5-ASA therapy* (Asacol®) 50 40 30 20 10 0 0 5 10 15 20 25 30 Time (months) *P=.001. Adapted with permission from Am J Med., Vol 114, Kane S, Huo D, Aikens J, Hanauer S. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis, pages 39-43, Copyright 2003 with permission from Excerpta Medica. Strategies for Optimizing Patient Adherence IBD is a chronic, lifelong illness Induce then maintain remission Reciprocal patient:clinician relationship Educate patient and family Individualize therapy/simplify regimen Promote emotional/psychological support Obtain patient’s commitment to therapeutic objectives Guided Self-Management in UC Intervention Group n=101 Personalized, guided self-management regimen Single 15-30-minute session – Relapse recognition – Treatment protocols Patients given written protocols Copy to primary MDs Robinson A, et al. Lancet. 2001;358:976-981. Control Group n=102 Routine treatment and follow-up Relapses Are Treated Earlier in Self-Managed Patients Proportion Untreated (%) 100 90 80 70 60 Control group 50 40 30 20 Intervention group 10 0 0 2 4 6 Time (days) Reprinted with permission from Elsevier (The Lancet. 2001;358:976-981). 8 10 12 Patient Self-Management Trends in self-management group (vs controls) – Fewer relapses (1.53 vs 1.93; P=NS) – Shorter duration of relapse if treated in first 24 h (17.7±17.1 d vs 25.5±37.4 d; P=.16) – 82% preferred self-management – 95% of controls said they were adopting self-management Robinson A, et al. Lancet. 2001;358:976-981.