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P462 Adalimumab improves treatment satisfaction with medication and work productivity amongst patients with ulcerative colitis in a clinical practice setting: results from INSPIRADA

S. Travis*1, B. Feagan2, L. Peyrin-Biroulet3, R. Panaccione4, S. Danese5, A. Lazar6, A. Robinson7, J. Petersson7, M. Bereswill6, M. Skup7, N. Chen7, S. Wang7, R. Thakkar7, J. Chao7

1Oxford University Hospitals, Oxford, United Kingdom, 2Robarts Research Institute, Ontario, Canada, 3University Hospital of Nancy, Les Nancy, France, 4University of Calgary, Medicine, Calgary, Canada, 5Istituto Clinico Humanitas, Milan, Italy, 6AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany, 7AbbVie Inc, North Chicago, Illinois, United States

Background

The efficacy and safety of adalimumab (ADA) in the treatment of moderate-to-severe ulcerative colitis (UC) has been demonstrated in randomised clinical trials. We assessed the effect of ADA on patient satisfaction with medication and work productivity amongst patients with UC in clinical practice.

Methods

INSPIRADA was a single-arm, multicountry, open-label study that evaluated the effect of ADA on clinical outcomes, costs of care, treatment satisfaction, and work productivity in patients with UC treated according to usual clinical practice. Adult patients with active UC, Physician’s Global Assessment (PGA) of ≥ 2 and Short Inflammatory Bowel Disease Questionnaire ≤ 45 at baseline (BL) who failed conventional treatment and who had experienced rectal bleeding within 7 days of BL were enrolled. Patients who did not respond to ADA by week 8 (PGA ≥ 2 and did not achieve Simple Clinical Colitis Activity Index response, defined as a decrease of ≥2 points compared with BL) were to discontinue ADA. Patients who lost response at or after week 8 could escalate to 40 mg ADA weekly dosing. Satisfaction with medication was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), a 100-point scale, with higher scores indicating greater satisfaction with medication. The Work Productivity and Activity Impairment (WPAI) outcomes were expressed as percentage of impairment, with higher values indicating greater impairment and less productivity. Comparisons between BL and week 26 measures for both TSQM and WPAI were made with the paired t-test. Missing data were imputed using last observation carried forward (LOCF).

Results

In total, 461 patients (55% male; mean age 42 years; 84% with no prior exposure to TNF antagonists) were enrolled in the study. Statistically significant (p < 0.001) improvements from BL to week 26 were seen in all 4 TSQM domains (Table 1).

Table 1 Change in TSQM and WPAI – Intent-to-Treat Population, LOCF

From BL to week 26, highly significant (p < 0.001) reductions were observed in time missed from work, impairment whilst working, and overall work impairment, with improved performance of daily activities. Significant improvement in treatment satisfaction and work productivity were seen as early as week 2.

Conclusion

ADA therapy significantly increased patient satisfaction with medication and improved work productivity amongst patients with moderate-to-severe UC in usual clinical practice.