P574 Effect of adalimumab on clinical outcomes and health-related quality of life 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
The efficacy and safety of adalimumab (ADA) for the treatment of moderate-to-severe ulcerative colitis (UC) has been demonstrated in randomised clinical trials. Limited data are available regarding the effects of ADA on clinical outcomes and health-related quality of life (HRQoL) in real-world clinical practice.
INSPIRADA was a single-arm, multi-country, open-label study that evaluated the effect of ADA on clinical outcomes, HRQoL and costs of care in patients with UC treated according to usual clinical practice. Patients (18 to 75 years old) with active UC, Physician’s Global Assessment (PGA) ≥ 2, and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) ≤ 45 at baseline (BL) who failed conventional treatment and experienced rectal bleeding within 7 days of BL were enrolled. Patients received 160/80 mg ADA at week 0/2 followed by 40 mg of ADA every other week at week 4 through week 26. Patients who did not respond to ADA by week 8 (PGA score ≥ 2 and did not achieve Simple Clinical Colitis Activity Index [SCCAI] 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. Clinical outcomes included SCCAI response and remission (defined as an SCCAI ≤ 2). Proportions of patients with SCCAI response and remission were calculated at weeks 2, 8, and 26 (patients were considered to be not in response/remission if SCCAI were missing). HRQoL was assessed using SIBDQ and the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) questionnaire. Change from BL to week 26 in SIBDQ and EQ-5D-5L was calculated. Data for the intent-to-treat population were analysed. Missing data were imputed using last observation carried forward (LOCF).
Data from 461 patients (55% male, mean age 42 years; 84% with no prior exposure to TNF antagonists) were analysed. Mean SCCAI at BL was 7.7. At week 2, 74% achieved SCCAI response and 27% achieved SCCAI remission. At week 8, 79% achieved SCCAI response, 49% were in remission, and 55% had no blood in their stool. At week 26, 67% achieved SCCAI response, 48% were in remission, and 57% had no blood in their stool. Significant improvements in SIBDQ and EQ-5D-5L were seen from baseline to week 26 (Table 1). The safety profile of ADA was consistent with that in previous clinical trials.
Table 1 Change in SCCAI, SIBDQ and EQ-5D-5L – Intent-to-Treat Population, LOCF
Rates of response and remission and improvements in HRQoL with ADA therapy for UC were clinically meaningful and consistent with results from randomised clinical trials.