Adalimumab Long-Term Effectiveness in Adalimumab-Naïve Patients with Crohn's Disease: Final Data from Pyramid Registry

Mo1661 ADALIMUMAB LONG-TERM EFFECTIVENESS IN ADALIMUMAB-NAÏVE PATIENTS WITH CROHN'S DISEASE: FINAL DATA FROM PYRAMID REGISTRY Edward V. Loftus, Geert R. D'Haens, Walter Reinisch, Jack Satsangi, Remo Panaccione, Sofie Berg, Gabriela Alperovich, Mareike Bereswill, Martha Skup, Joel H. Petersson, Anne M. Robinson Background: PYRAMID was an international multi-center non-interventional postmarketing registry assessing long-term safety and effectiveness of Humira® (adalimumab [ADA]) as used in routine clinical practice. Patients with and without prior ADA experience were allowed to enroll. This analysis evaluates the long-term effectiveness of ADA in ADA-naïve, i.e., patients who had not received ADA before the registry enrollment, adult patients with moderate to severe Crohn's disease (CD) who were treated according to the local product label. Methods: All patients entering the registry were followed for up to 6 years. Effectiveness of ADA was measured using Physician's Global Assessment (PGA; [a composite of Harvey Bradshaw Index and rectal bleeding score]), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and 4 components of the Work Productivity and Activity Impairment questionnaire (WPAI), including absenteeism, presenteeism, overall work impairment, and activity impairment. Effectiveness measures, captured in all patients who received at least 1 dose of ADA in the registry and had at least 1 post-enrollment measurement, were summarized descriptively by the number of observations that were not missing at each registry visit; data were used as observed. Results: Among 5025 patients evaluated in the registry, 2657 patients (52.9%) were ADA-naïve. Of them, 1531 patients (57.6%) were female; mean age 37.7 years at enrollment. Mean±SD ADA exposure for the ADA-naïve subgroup during the registry was 1179.6±837.3 days. A total of 1413 patients (53.2%) had prior exposure to anti-TNF biologics; 1039 (39.1%) and 914 patients (34.4%) used immunomodulators and corticosteroids, respectively, at enrollment. Mean change from enrollment (baseline) in effectiveness measures for patients with CD is shown in the table. Mean PGA and SIBDQ scores as well as WPAI domain scores improved in ADA-naïve patients from enrollment to as early as 1 year and sustained for up to 6 years (table). No new safety signals were identified. Conclusions: At 1 year after entering the international postmarketing registry of ADA use in routine clinical practice, clinically meaningful improvements in disease activity, work productivity, and activity impairment were achieved in ADA-naïve patients with moderately to severely active CD. These improvements were maintained for up to 6 years of the registry.

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P<0.001 compared with BL using paired t-test. bOnly patients who were employed were assessed.

Mo1660 EFFECT OF ADALIMUMAB ON EXTRAINTESTINAL MANIFESTATIONS AMONG PATIENTS WITH ULCERATIVE COLITIS IN A CLINICAL PRACTICE SETTING: RESULTS FROM INSPIRADA Simon P. Travis, Brian G. Feagan, Laurent Peyrin-Biroulet, Remo Panaccione, Silvio Danese, Andreas Lazar, Anne M. Robinson, Roopal B. Thakkar, Brandee Pappalardo, Joel H. Petersson, Mareike Bereswill, Naijun Chen, Martha Skup Background: Extraintestinal manifestations (EIMs) are common in patients with ulcerative colitis (UC) and can have a significant impact on patient morbidity and quality of life1. We assessed the effect of adalimumab (ADA) therapy on the resolution of EIMs among patients with moderate to severe UC in clinical practice. Methods: INSPIRADA was a single-arm, multi-country, open-label study evaluating 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. Adults with active UC, Physician's Global Assessment (PGA) ≥2 and Short Inflammatory Bowel Disease Questionnaire ≤45 at baseline (BL) who failed conventional treatment and who experienced rectal bleeding ≤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 were to discontinue ADA. Patients who lost response at or after Week 8 could escalate to 40 mg ADA weekly. The presence of EIMs (arthritis, pyoderma gangrenosum, erythema nodosum, and uveitis) were collected in the SCCAI at BL and Weeks 2, 8 and 26. McNemar's test was used to compare the presence of any EIM at Weeks 2, 8 and 26 with BL. In a subset of patients with EIMs at BL, EIM resolution was assessed at Week 2, 8 and 26, defined as no reported EIM at the respective visit; durable EIM resolution at Weeks 2 and 8 was defined as no EIM at the respective visit and subsequent visit(s). Missing data were imputed using last observation carried forward. Results: Data from 461 patients were analysed. At BL, 88 patients (19.1%) had an EIM. The most commonly reported EIM was arthritis (84 of 88 patients). Pyoderma gangrenosum, erythema nodosum and uveitis each were reported in <1% of patients at BL and at Weeks 2, 8 and 26. The overall percentage of patients with any EIM decreased significantly (P<.001) from BL over time: 13.2%, 11.7% and 10.8% had any EIMs at Weeks 2, 8 and 26, respectively. Similar decreasing percentages were seen for patients with arthritis: 13.0%, 11.7% and 10.8% at Weeks 2, 8 and 26, respectively. Among those with any EIM at BL, resolution of EIMs increased over time: 39.8%, 52.3% and 63.6% at Weeks 2, 8 and 26, respectively; durable resolution was 23.9% and 44.3% at Weeks 2 and 8, respectively. Among those with arthritis at BL, resolution rates were 36.9%, 50.0% and 61.9% at Weeks 2, 8 and 26, respectively; durable resolution was 20.2%, 41.7% and 61.9%, respectively. Conclusion: ADA therapy reduced EIMs among patients with moderate to severe UC in usual clinical practice, with EIM resolution in 60% by week 26. Reference: 1. Vavricka SR et al. Inflamm Bowel Dis 2015;21(8):1982-1992.

Mo1662 PRESENCE OF ANGIODYSPLASIA IS ASSOCIATED WITH A DECREASED QUALITY OF LIFE: A CROSS-SECTIONAL COHORT Karina Grooteman, Mijntje Matheeuwsen, Erwin van Geenen, Joost Drenth Introduction: Angiodysplasia patients can suffer from recurrent bleeding which can lead to chronic anemia. Chronic anemia is associated with a decreased quality of life (QoL) in multiple diseases. QoL is a valid patient reported outcome measure and improvement of QoL is an important treatment goal in clinical practice. To date, there is no literature on the effect of angiodysplasias on QoL. Aim: To investigate aspects of QoL in a cohort of patients with endoscopic detected angiodysplasias. It was hypothesized that angiodysplasia patients have a decreased QoL and a higher level of fatigue, compared to the age-matched general population. Methods: We performed a single center, cross-sectional patient-reported outcome study in patients with at endoscopy at least one proven angiodysplasia. QoL and level of fatigue were respectively measured by the Short Form-36 (SF-36) and the Multi Fatigue Inventory-20 (MFI-20). We distinguished 3 subgroups based on disease severity: 1) with treatment for angiodysplasias, 2) without treatment for angiodysplasias and 3) without recent hospital visits. The primary outcome was the physical component summary (PCS) score of the SF-36. Norm values of age-matched general population were used as control. Multivariate regression analyses were performed to correct for baseline differences between the disease severity subgroups. Results: A total of 144 patients completed the questionnaires (response rate = 62%; mean age = 68 years; 65% men). Angiodysplasia patients have a significant lower PCS compared to age-matched general population (respectively 41.0 vs. 43.3, p=0.01). Disease severity, e.g. if patients were treated, is independently of age, gender and comorbidities, associated with a negative outcome on QoL (ß -4.6, 95% CI -7.1-

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weekly. Outcomes were assessed for pts who dose escalated. Clinical outcomes included Simple Clinical Colitis Activity Index (SCCAI) response (SCCAI decrease ≥2) and remission (defined as an SCCAI ≤2). HRQoL was assessed using SIBDQ and the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) questionnaire. Satisfaction with medication was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). Work Productivity and Activity Impairment (WPAI) outcomes were determined. Change from BL to Wk 26 in HRQoL, treatment satisfaction, and WPAI outcomes were calculated. Missing data were imputed using nonresponder imputation for response/remission and last observation carried forward for all other outcomes. Results: Data from 129 pts who dose escalated were analysed. At Wk 26, 64% of pts who dose escalated achieved SCCAI response and 33% achieved SCCAI remission (Table). Except for work time missed and convenience in TSQM among pts who dose escalated, statistically significant (P<0.001) improvements from BL to Wk 26 were seen in work productivity, performance of daily activities, SIBDQ, EQ5D-5L and treatment satisfaction. The safety profile of ADA among pts who dose escalated was consistent with that of pts who did not dose escalate. Conclusion: In pts with UC who lost response, ADA dose escalation was an effective option to recapture response and remission. Significant improvements in HRQoL, treatment satisfaction and work productivity were also observed. 1Wolf et al. APT 2014;40:486-97.