Abstract

ObjectiveTo describe the real-world use of adalimumab for maintenance treatment of ulcerative colitis (UC) and associated healthcare costs in English hospitals.DesignRetrospective cohort study.SettingAnalysis of NHS Hospital Episode Statistics linked with pharmacy dispensing data in English hospitals.PatientsAdult UC patients receiving ≥240mg during adalimumab treatment induction, subsequently maintained on adalimumab.OutcomesFrequency and pattern of adalimumab use and dose escalation during maintenance treatment and associated healthcare costs (prescriptions and hospital visits).Results191 UC patients completed adalimumab treatment induction. 83 (43.46%) dose escalated during maintenance treatment by ≥100% (equivalent to weekly dosing) (median time to dose escalation: 139 days). 56 patients (67.47%) subsequently de-escalated by ≥50% (median time to dose de-escalation: 21 days). Mean all-cause healthcare costs for all patients ≤12 months of index were £13,892. Dose escalators incurred greater mean healthcare costs than non-escalators ≤12 months of index (£14,596 vs. £13,351). Prescriptions accounted for 96.49% of UC-related healthcare costs (£11,090 of £11,494 in all patients).ConclusionsWithin the cohort, 43.46% of UC patients escalated their adalimumab dose by ≥100% and incurred greater costs than non-escalators. The apparent underestimation of adalimumab dose escalation in previous studies may have resulted in underestimated costs in healthcare systems.

Highlights

  • Tumour necrosis factor-alpha (TNF-α) inhibitors infliximab, adalimumab, and golimumab are approved for the treatment of moderately to severely active ulcerative colitis (UC) in adults who have inadequate response, intolerance or contraindications to conventional therapy,[1,2,3]

  • 191 UC patients completed adalimumab treatment induction. 83 (43.46%) dose escalated during maintenance treatment by 100%. 56 patients (67.47%) subsequently de-escalated by 50%

  • Dose Escalation among Ulcerative Colitis Patients Treated with Adalimumab

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Summary

Introduction

Tumour necrosis factor-alpha (TNF-α) inhibitors infliximab, adalimumab, and golimumab are approved for the treatment of moderately to severely active ulcerative colitis (UC) in adults who have inadequate response, intolerance or contraindications to conventional therapy,[1,2,3]. The efficacy of adalimumab in UC was demonstrated in two Phase 3 studies (ULTRA 1 and 2) and an extension study (ULTRA 3).[6,7,8] The induction regimen for adult UC patients is 160mg at Week 0 and 80mg at Week 2. In ULTRA 2, approximately 16% of previously TNF-α inhibitor-naïve patients were dose escalated from fortnightly to weekly treatment to maintain response or remission.[4]

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