Maintaining stable symptom control in inflammatory bowel disease: a retrospective analysis of adherence, medication switches and the risk of relapse

Abstract

SummaryBackground Maintenance therapy with 5-aminosalicylic acid (5-ASA) is a key strategy for preventing relapse in many patients with inflammatory bowel disease (IBD). Factors which disrupt 5–ASA delivery, such as non-adherence and 5-ASA switches, may destabilise symptom control.Aim To investigate the impact of non-adherence and medication switches on stable symptom control in UK patients with IBD.Methods A retrospective cohort study was conducted using a UK dispensing database. Adherence was analysed in randomised matched samples for each of the six leading oral mesalazine formulations, measured by medication possession ratio (MPR); MPR ≥80% was classified as adherent. Relationships among adherence, switch and relapse were analysed over 18 months in patients receiving continuous mesalazine therapy throughout a 6–month baseline period (primary subgroup analysis). Relapses of active ulcerative colitis were identified using a doubling of MPR as a proxy.Results Only 39% of patients in the matched samples (n = 1200) were classed as adherent. No significant differences in adherence were observed among mesalazine formulations. In the primary subgroup analysis (n = 568), non-adherent patients had a significantly greater risk of relapse than adherent patients (RR = 1.44, 95% CI = 1.08–1.94; P = 0.014). Among adherent patients (n = 276), those who switched had a 3.5-fold greater risk of relapse than those who did not switch (95% CI = 1.16–10.62; P = 0.008).Conclusions Both non-adherence and mesalazine switches in adherent patients were associated with significant increases in the risk of relapse, suggesting that disruption of mesalazine maintenance therapy may destabilise symptom control. These findings provide evidence to advocate caution when considering mesalazine switches for stable patients.

Commentary: 5-ASA switches in IBD, adherence and flares - authors' reply

“…In the paper, 2 we state that the proxy measure is unvalidated, and agree that clinical data, which would accurately represent flare activity, would be desirable. However, this was not available, and we believe it was therefore valid to develop a proxy measure of flare.…”

“…However, the sensitivity and specificity of the history and PPI response to diagnose GERD are mediocre. 1,2 As such, many with continued heartburn require a diagnostic work up that typically includes endoscopy and pH or impedance-pH studies, to differentiate refractory GERD 3 from functional heartburn (FH). Routine biopsies of the distal oesophagus to diagnose GERD are not recommended by the recent ACG guidelines.…”

Mesalazine preparations for the treatment of ulcerative colitis: Are all created equal?

“…There was also a 60% reduction in hospital visits due to flare of disease, 45% reduction in family doctor visits and 50% reduction in steroid usage [53] . In addition, Motoya et al [54] reported a retrospective analysis of 46 patients with active ulcerative colitis, who were switched from a [55] found in a retrospective study that stable patients who switched mesalazine formulations had a 3.5 fold greater risk of relapse compared to those who did not switch. This indicates that the mesalazine formulations are not bioequivalent and disruptions to maintenance mesalazine should be avoided.…”

The role of family nurse practitioners : promoting oral medication adherence to maintenance treatment among adolescents with inflammatory bowel disease

“…Non-adherence or disruption of maintenance therapy destabilizes disease activity, leading to exacerbations of symptoms, such as nausea, abdominal pain, fatigue, diarrhea, fistulae or abscesses (Robinson, Hankins, Wiseman, & Jones, 2013). In the long term, adherence to maintenance medications significantly reduces the risk of developing colorectal cancer by up to 75% in UC patients (Van et al, 2005).…”

“…Achieving disease remission results in significant improvement of bowel symptoms, but also overall physical and psychosocial wellbeing. Exacerbations of clinical symptoms can be a source of psychological issues in adolescents (Robinson et al, 2013).…”