Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA

Abstract

Background and aims: Randomised trials have described the benefits of adalimumab [ADA] for ulcerative colitis [UC]; however, few data are available on health-related quality of life [HRQL] and health care costs in clinical practice.

Methods: InspirADA, a multicentre, prospective study, evaluated the effect of ADA in patients with moderate to severe UC treated according to usual clinical practice. Outcomes assessed were: Simple Clinical Colitis Activity Index [SCCAI] response/remission rates; changes in HRQL; all-cause direct costs; and UC-related direct and indirect costs from baseline to Week 26.

Results: Data from 463 patients were analysed. At Week 26, 67% (95% confidence interval [CI]: 62%, 71%) of patients achieved response; 48% [95% CI: 44%, 53%] were in remission. For the overall population, significant [all p < 0.001] improvements from baseline to Week 26 were observed for the Short Inflammatory Bowel Disease Questionnaire [SIBDQ] (mean change ± standard deviation [SD]: 17.4 ± 14.5) and the European Quality of Life-5 Dimensions-5 Level [EQ-5D-5L] (index: 0.1 ± 0.2; visual analogue scale [VAS]: 19.5 ± 25.8). Parallel improvements were seen in work productivity [11% absolute decrease in absenteeism; 25% absolute decrease in impairment while working; and 27% absolute decrease in impairment of ability to perform daily activities, all p < 0.001]. Among study completers, cumulative all-cause medical costs and UC-related medical costs were significantly [both p < 0.001] reduced by 59% and 77%, respectively, 6 months after initiation of therapy compared with the preceding 6 months. The safety profile of ADA was consistent with that observed in previous clinical trials.

Conclusions: ADA therapy in usual clinical practice is effective at improving and maintaining symptomatic control, improving HRQL, and decreasing costs of medical care among patients with UC.

Keywords: Ulcerative colitis; health care costs; patient outcomes.

Figure 1.

Patient disposition. ^aA total of 80/463 patients discontinued adalimumab [ADA] owing to a lack of efficacy; of these, 66 patients discontinued ADA by Week 8.

Figure 2.

[A] Percentage of patients who achieved SCCAI response and SCCAI remission after ADA therapy, and 95% CI. Clinical response was defined as a decrease of ≥ 2 points from baseline in SCCAI. Remission was defined as SCCAI ≤ 2. Missing data were imputed using NRI. [B] Percentage of patients with no blood in their stool after ADA therapy and 95% CI. Missing data were imputed using LOCF. Significant change [denoted by asterisk] from baseline [p < 0.001] using McNemar’s test was seen at Weeks 2, 8, and 26. SCCAI, Simple Clinical Colitis Activity Index; ADA, adalimumab; CI, confidence interval; NRI, non-responder imputation; LOCF, last observation carried forward.

Figure 3.

Mean change from baseline in total SIBDQ score and 95% CI. Missing data were imputed using LOCF. A nine-point change in the SIBDQ is considered an MCID. Significant change [denoted by asterisk] from baseline [p < 0.001] using paired t test was seen at Weeks 2, 8, and 26. CI, confidence interval; MCID, minimal clinically important difference; SD, standard deviation; SIBDQ, Short Inflammatory Bowel Disease Questionnaire; LOCF, last observation carried forward.

Figure 4.

Mean change from baseline to week 26 in WPAI and 95% CI. A decrease of 7% in WPAI outcome score for an individual patient is considered a MCID. Missing data were imputed using LOCF. Significant change [denoted by asterisk] from baseline [p < 0.001] using paired t test was observed for work time missed, impairment while working, overall work impairment, and activity impairment. Except for activity impairment, which was assessed for all patients, WPAI outcomes were assessed for employed patients only. MCID, minimal clinically important difference; SD, standard deviation; WPAI, Work Productivity and Activity Impairment; CI, confidence interval; LOCF, last observation carried forward.

Figure 5.

Mean change from baseline to Week 26 in TSQM domain scores and 95% CI. Missing data were imputed using LOCF. Significant change [denoted by asterisk] from baseline [P < 0.001] was seen for all four TSQM domains using paired t test. SD, standard deviation; TSQM, Treatment Satisfaction Questionnaire for Medication; CI, confidence interval; LOCF, last observation carried forward.