Dataset Information

Dose Escalation and Healthcare Resource Use among Ulcerative Colitis Patients Treated with Adalimumab in English Hospitals: An Analysis of Real-World Data.

ABSTRACT:

Objective

To describe the real-world use of adalimumab for maintenance treatment of ulcerative colitis (UC) and associated healthcare costs in English hospitals.

Design

Retrospective cohort study.

Setting

Analysis of NHS Hospital Episode Statistics linked with pharmacy dispensing data in English hospitals.

Patients

Adult UC patients receiving ≥240mg during adalimumab treatment induction, subsequently maintained on adalimumab.

Outcomes

Frequency and pattern of adalimumab use and dose escalation during maintenance treatment and associated healthcare costs (prescriptions and hospital visits).

Results

191 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).

Conclusions

Within 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.

SUBMITTER: Black CM

PROVIDER: S-EPMC4768958 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundA gap remains in documenting the impact of anti-tumor necrosis factor therapy on disease burden in ulcerative colitis (UC) patients treated in a real-world setting. The use of patient-reported outcomes (PROs) has been discussed as a primary endpoint in the context of the FDA PRO Guidance, for labelling purposes. Specifically, the efficacy and safety of adalimumab have been demonstrated in pivotal trials; however, data are needed to understand how clinical results translate into improvements in key aspects of the daily lives of UC patients, such as symptoms, health-related quality of life (HRQoL), and disability.AimTo assess real-world effectiveness of adalimumab on PRO measures in patients with moderate-to-severe UC.MethodsUCanADA was a single arm, prospective, 1-year multicenter Canadian post-marketing observational study in which multiple PRO questionnaires were completed-with psychologic distress/depression symptoms as the primary endpoint-by patients with moderate-to-severe UC. Assessments were performed during patients' routine care visit schedule, which was at the initiation of adalimumab (baseline), after induction (approximately 8 wk), and 52 wk after baseline. Additional optional assessments between weeks 8 and 52 were collected at least once but no more than two times during this period. Serious safety events and per-protocol adverse events were collected.ResultsFrom 23 Canadian centres, 100 patients were enrolled and 48 completed the study. Measured with the Patient Health Questionnaire-9 items at week 52, 61.5% (40/65) [95% confidence interval (CI): 49.7%-73.4%] of the patients improved in psychologic distress/depression symptoms, which was slightly higher in completers [65.9% (29/44); 95%CI: 51.9%-79.9%)]. At week 52, clinical response and clinical remission were achieved respectively by 65.7% (44/73) and 47.8% (32/73) of the patients. The odds of improving depressive symptoms for those achieving a clinical remission at week 52 was 7.94 higher compared with those not achieving a clinical remission (CI: 1.42, 44.41; P = 0.018). Significant changes from baseline to weeks 8 and 52 were observed in disability, HRQoL, and fatigue. Meaningful improvement was reported in work impairment.ConclusionAt week 52, over 60% of the UCanADA patients had depressive symptoms significantly reduced, as well as HRQoL, fatigue symptoms, and work impairment improved. No new safety signals were detected.