Clinical Management Clinical Management and Adherence Issues and Adherence Issues

in IBDin IBD

Illness-Related Factors Illness-Related Factors Affecting Adherence in IBDAffecting Adherence in IBD

Severity, extent, duration of diseaseSeverity, extent, duration of disease

Frequency, duration, intensity of flare-upsFrequency, duration, intensity of flare-ups

Type and severity of complicationsType and severity of complications

Patients with well-controlled disease and Patients with well-controlled disease and few flares are most likely to discontinue few flares are most likely to discontinue maintenance therapymaintenance therapy

Treatment-Related Factors Treatment-Related Factors Affecting Adherence in IBDAffecting Adherence in IBD

ConvenienceConvenience– Dosage/dosing Dosage/dosing

regimenregimen– FormulationFormulation– Method of Method of

administrationadministration– Pill sizePill size

Cost/reimbursementCost/reimbursement

Choice of medicationChoice of medication– Sulfasalazine, Sulfasalazine,

corticosteroidscorticosteroids• Need to balance efficacy Need to balance efficacy

vs safetyvs safety• Start with low doses, Start with low doses,

titrate slowly upwardtitrate slowly upward– MesalamineMesalamine

• Dose-related efficacy but Dose-related efficacy but not toxicitynot toxicity

• Initiate and maintain Initiate and maintain treatment with high treatment with high dosesdoses

• Induction dose = Induction dose = maintenance dosemaintenance dose

Patient-Related Factors Patient-Related Factors Affecting AdherenceAffecting Adherence

Inadequate educationInadequate education11; inadequate skills/knowledge ; inadequate skills/knowledge to follow regimento follow regimen22

Patients’ main concernsPatients’ main concerns– Uncertain nature of IBD Uncertain nature of IBD – Effects of medicationsEffects of medications33

Patients’ belief systems (treatment will not help, Patients’ belief systems (treatment will not help, side effects outweigh benefits)side effects outweigh benefits)22

Psychiatric disordersPsychiatric disorders44

Male, unmarried, younger ageMale, unmarried, younger age5,65,6

Patterns of nonadherencePatterns of nonadherence77

11Martin A, et al. Martin A, et al. Ital J Gastroenterol.Ital J Gastroenterol. 1992;24:477-480. 1992;24:477-480. 22Levy RL, Field AD. Levy RL, Field AD. Am J Gastroenterol.Am J Gastroenterol. 1999;94:1733-1742. 1999;94:1733-1742. 33Drossman DA, et al. Drossman DA, et al. Psychosom Med.Psychosom Med. 1991;53:701-712. 1991;53:701-712. 44Nigro G, et al. Nigro G, et al. J Clin J Clin Gastroenterol.Gastroenterol. 2001;32:66-68. 2001;32:66-68. 55Kane S. Kane S. Am J Gastroenterol.Am J Gastroenterol. 2001;96:2929-2932. 2001;96:2929-2932. 66Kane S. Kane S. Am J Am J Gastroenterol.Gastroenterol. 2001;96(suppl):S296. 2001;96(suppl):S296. 77Kane S. In: Bayless TM, Hanauer SB, eds. Kane S. In: Bayless TM, Hanauer SB, eds. Advanced Therapy of Advanced Therapy of Inflammatory Bowel Disease.Inflammatory Bowel Disease. Hamilton, Ontario: BC Decker, 2001:9-11. Hamilton, Ontario: BC Decker, 2001:9-11.

Prevalence of Nonadherence to Prevalence of Nonadherence to IBD Maintenance TherapyIBD Maintenance Therapy

Failure to take medication by patients with Failure to take medication by patients with other illnesses: 25%–50%other illnesses: 25%–50%11

41% of patients on maintenance sulfasalazine 41% of patients on maintenance sulfasalazine do not take prescribed dosagesdo not take prescribed dosages22

Clinical research protocols overestimate Clinical research protocols overestimate drug adherencedrug adherence

11Blackwell B. Blackwell B. Clin Pharmacol Ther.Clin Pharmacol Ther. 1972;13:841-848. 1972;13:841-848. 22van Hees PAM, van Tongeren JHM. van Hees PAM, van Tongeren JHM. J Clin J Clin Gastroenterol.Gastroenterol. 1982;4:333-336. 1982;4:333-336.

Impact of Nonadherence Impact of Nonadherence on Outcomes in IBDon Outcomes in IBD

**PP=.001.=.001.

Adapted with permission from Adapted with permission from Am J Med.Am J Med., Vol 114, Kane S, Huo D, Aikens J, Hanauer S. Medication , 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 nonadherence and the outcomes of patients with quiescent ulcerative colitis, pages 39-43, Copyright 2003 with permission from Excerpta Medica.with permission from Excerpta Medica.

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Time (months)Time (months)252520201515101055

Adherent toAdherent to5-ASA therapy5-ASA therapy

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Nonadherent toNonadherent to5-ASA therapy*5-ASA therapy*

(Asacol(Asacol®®))

Strategies for Optimizing Strategies for Optimizing Patient AdherencePatient Adherence

IBD is a chronic, lifelong illnessIBD is a chronic, lifelong illness

Induce Induce thenthen maintain remission maintain remission

Reciprocal patient:clinician relationshipReciprocal patient:clinician relationship

Educate patient and familyEducate patient and family

Individualize therapy/simplify regimenIndividualize therapy/simplify regimen

Promote emotional/psychological supportPromote emotional/psychological support

Obtain patient’s commitment to Obtain patient’s commitment to therapeutic objectivestherapeutic objectives

Guided Self-Management Guided Self-Management in UCin UC

Personalized, guided Personalized, guided self-management regimenself-management regimen

Single 15-30-minute sessionSingle 15-30-minute session– Relapse recognitionRelapse recognition– Treatment protocolsTreatment protocols

Patients given written Patients given written protocols protocols

Copy to primary MDsCopy to primary MDs

Routine treatment Routine treatment and follow-upand follow-up

Intervention GroupIntervention Groupn=101n=101

Control GroupControl Groupn=102n=102

Robinson A, et al. Robinson A, et al. Lancet.Lancet. 2001;358:976-981. 2001;358:976-981.

Relapses Are Treated Earlier in Relapses Are Treated Earlier in Self-Managed PatientsSelf-Managed Patients

Reprinted with permission from Elsevier (Reprinted with permission from Elsevier (The Lancet.The Lancet. 2001;358:976-981). 2001;358:976-981).

Time (days)Time (days)

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Patient Self-ManagementPatient Self-Management

Trends in self-management group (vs controls)Trends in self-management group (vs controls)– Fewer relapses (1.53 vs 1.93; Fewer relapses (1.53 vs 1.93; PP=NS)=NS)– Shorter duration of relapse if treated in first Shorter duration of relapse if treated in first

24 h (17.7±17.1 d vs 25.5±37.4 d; 24 h (17.7±17.1 d vs 25.5±37.4 d; PP=.16)=.16)– 82% preferred self-management82% preferred self-management– 95% of controls said they were adopting 95% of controls said they were adopting

self-managementself-management

Robinson A, et al. Robinson A, et al. Lancet.Lancet. 2001;358:976-981. 2001;358:976-981.