Longitudinal non‐adherence predicts treatment escalation in paediatric ulcerative colitis

Abstract

Summary Background Medication non‐adherence in paediatric ulcerative colitis (UC) has been associated with negative health outcomes including flares in disease activity. However, no studies to date have examined longitudinal adherence to maintenance medication in a prospective controlled trial. Aims To determine whether objectively measured adherence to standardised mesalazine (mesalamine) therapy over time was related to remission at 52 weeks and the need for treatment escalation in newly diagnosed paediatric patients with UC Methods PROTECT (NCT01536535) was a prospective, inception cohort, multi‐site study of paediatric patients aged 4‐17 years with newly diagnosed UC followed for 52 weeks. Patients received standardised mesalazine, with pre‐established criteria for escalation to thiopurines or anti‐TNFα inhibitors. Patients used pill bottles with electronic caps to monitor mesalazine adherence. We tested whether longitudinal adherence to mesalazine predicted steroid‐free remission at week 52 (i.e. quiescent disease on mesalazine alone with no corticosteroids ≥4 weeks prior) and need for treatment escalation (i.e. introduction of immunomodulators, calcineurin‐inhibitors or anti‐TNFα inhibitors). Results Among 268 patients, average mesalazine adherence trajectories did not predict week 52 steroid‐free remission. Declining adherence over time strongly predicted treatment escalation (β = −.037, P = .001). By month 6, adherence rate ≤85.7% was associated with treatment escalation. Conclusions Non‐adherence may have affected therapeutic efficacy of standardised mesalazine, thereby contributing to need for treatment escalation. Routine adherence monitoring for at least 6 months following treatment initiation and addressing adherence difficulties early in the disease course are recommended.

A Micro‐longitudinal Approach to Measuring Medication Adherence in Pediatric Inflammatory Bowel Diseases

“…Adolescents and young adults (AYAs) with inflammatory bowel diseases (IBD) struggle to adhere to medication with nonadherence rates ranging from 50% to 88% (1,2). Consequences include disease relapse (3), increased healthcare utilization (4), and treatment escalation (5). Nonadherence may result from the complexity of the regimen (6), which consists of multiple medications across dosing schedules and formulations (7).…”

Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease – Data from the multicenter CEDATA-GPGE registry study

“…Patients with lower therapy adherence require therapy escalation significantly more often ( 37 ). In the Cox regression analysis performed in the present study, first-line prescription significantly prevented treatment failure, whereas a high infliximab induction dose was associated with treatment failure.…”

Ethical considerations in using sensors to remotely assess pediatric health behaviors.

“…Despite the benefits of adhering to a prescribed medication, up to 50% of children and 75% of adolescents demonstrate nonadherence, or medication-taking behavior that does not align with agreed-upon recommendations from the clinician (Rapoff, 2010). Nonadherence is one cause of treatment failure (Sabaté, 2003) and is associated with preventable disease complications (Walsh et al, 2002), unnecessary increases in medications (Carmody et al, 2019), lower quality of life (Wu et al, 2014), increased urgent health care utilization (McGrady & Hommel, 2013), and health care spending totaling more than $300 billion per year (DiMatteo, 2004). A critical component of efforts to increase medication adherence includes the routine and valid assessment of adherence (Pai & McGrady, 2015).…”