Longitudinal non‐adherence predicts treatment escalation in paediatric ulcerative colitis. Issue 8 (2nd August 2019)

• Record Type: Journal Article
• Authors: Carmody, Julia K.; Plevinsky, Jill; Peugh, James L.; Denson, Lee A.; Hyams, Jeffrey S.; Lobato, Debra; LeLeiko, Neal S.; Hommel, Kevin A.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 50:Issue 8(2019)
• Page Start: 911
• Page End: 918
• Publication Date: 2019-08-02
• Subjects: adherence trajectories -- children -- clinical remission -- paediatric -- treatment escalation -- ulcerative colitis; Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.15445
• Languages: English
• ISSNs: 0269-2813

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.