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Introduction Limited real world data are available regarding the effects of adalimumab (ADA) on UK patients with moderate to severe ulcerative colitis (UC). Methods INSPIRADA was a single-arm, multi-country, open-label study that evaluated the effect of ADA on patients with UC treated according to usual clinical practice. Adults with active moderate to severe UC who failed immunosuppressive therapies and experienced rectal bleeding within 7 days of baseline (BL) were enrolled. Prior use of anti-TNF was allowed. Clinical outcomes included Simple Clinical Colitis Activity Index (SCCAI) response (a decrease ≥2 points compared to BL) and remission (SCCAI ≤2). HRQoL (EQ-5D-5L and SIBDQ), treatment satisfaction with medication (TSQM), and work productivity and activity impairment (WPAI) were measured from BL to week 26. Direct medical costs (excluding ADA costs) were estimated using 2014 UK National Health Service reference costs. Indirect costs were based on the WPAI using average weekly earnings from the 2014 UK Annual Salary Survey of Hours and Earnings. Change (defined as 6 mo after start of ADA vs 6 mo before) in resource use and costs were calculated. Data for the intent-to-treat population in UK were analysed. Missing data were imputed using last observation carried forward. Results Data from 90 UK patients (58% male, mean age 39 yrs) were analysed. Mean SCCAI at BL was 8.2. At week 2, 74% achieved SCCAI response and 21% achieved SCCAI remission. At week 8, 73% achieved SCCAI response, 40% in remission and 49% had no blood in stool. At week 26, 66% achieved SCCAI response, 42% in remission and 51% had no blood in stool. Significant improvements, as early as within 2 weeks, in SIBDQ (19.5 points, p Conclusion Real world rates of response, remission and improvements in HRQoL with ADA for UK patients with moderate to severe UC were clinically meaningful. ADA improved work productivity, increased patient satisfaction with therapy and reduced health care associated costs for these patients in the UK. Disclosure of Interest P. Irving Grant/research support from: AbbVie; Falk; Ferring; Genentech/Roche; Hospira; Merck; Pharmacosmos; Shire; Takeda; Tillotts; Topivert; Vifor and Warner Chilcott, Conflict with: Advisor/invited lecturer for: AbbVie; Falk; Ferring; Genentech/Roche; Hospira; Merck; Pharmacosmos; Shire; Takeda; Tillotts; Topivert; Vifor and Warner Chilcott, F. Cummings Conflict with: Advisor/lectures for: Takeda, Abbvie, MSD, Biogen, Napp, Hospira, Janssen, S. Bloom Conflict with: Advisor/lectures for: Takeda, Tillotts, Abbvie, MSD, Pharmacosmos, Vifor, Johnson and Johnson, A. Lazar Shareholder of: AbbVie, Employee of: AbbVie, A. Robinson Shareholder of: AbbVie, Employee of: AbbVie, B. Pappalardo Shareholder of: AbbVie, Employee of: AbbVie, M. Bereswill Shareholder of: AbbVie, Employee of: AbbVie, M. Skup Shareholder of: AbbVie, Employee of: AbbVie, N. Chen Shareholder of: AbbVie, Employee of: AbbVie, T. Finney-Hayward Shareholder of: AbbVie, Employee of: AbbVie, S. Wang Shareholder of: AbbVie, Employee of: AbbVie, R. Thakkar Shareholder of: AbbVie, Employee of: AbbVie, S. Travis Grant/research support from: AbbVie; Asahi; Boehringer Ingelheim; BMS; Cosmo; Elan; Ferring; FPRT Bio; Genentech/Roche; Genzyme; Glenmark; GW Pharmaceuticals; Lilly; Merck; Novartis; Novo Nordisk; Ocera; Pfizer; Shire; Santarus; SigmoidPharma; Synthon; Takeda; Tillotts; Topivert; Trino Therapeutics with Wellcome Trust; UCB Pharma; Vertex; VHsquared; Vifor; Warner Chilcott and Zeria, Conflict with: Advisor or paid instructor for: AbbVie; Asahi; Boehringer Ingelheim; BMS; Cosmo; Elan; Ferring; FPRT Bio; Genentech/Roche; Genzyme; Glenmark; GW Pharmaceuticals; Lilly; Merck; Novartis; Novo Nordisk; Ocera; Pfizer; Shire; Santarus; SigmoidPharma; Synthon; Takeda; Tillotts; Topivert; Trino Therapeutics with Wellcome Trust; UCB Pharma; Vertex; VHsquared; Vifor; Warner Chilcott and Zeria. All advisory boards were suspended Q1 2012–14 while President of ECCO

Background ASAS40 response has been used as a primary endpoint in clinical trials of patients (pts) with axial spondyloarthritis (axSpA), and ASDAS inactive disease is recommended as a treatment target. However, the relationships between these clinical measures and patient-reported outcomes (PROs) are not well understood. Objectives To assess the impact of achieving ASAS40 response or ASDAS inactive disease state on PROs among pts with non-radiographic axSpA (nr-axSpA). Methods Data were drawn from ABILITY-1, a Phase 3 trial of adalimumab (ADA) vs. placebo (PBO) in pts with nr-axSpA (meeting ASAS axial SpA criteria but not modified New York criteria for AS) 1 . Pts (N=185) were randomized to ADA or PBO for 12 weeks of double-blind treatment. Physical function was assessed with the disability index of the Health Assessment Questionnaire for the Spondyloarthropathies (HAQ-S). HRQOL was assessed with the Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score. Work productivity was assessed with the Work Productivity and Activity Impairment (WPAI) Questionnaire. For this analysis, pts were grouped by clinical responses i.e., ASAS40 response and disease activity state (inactive [ASDAS 3.5]) at week 12 and further stratified by treatment arm (ADA vs. PBO). Changes in PROs from baseline to Week 12 were compared between groups using ANCOVA with adjustment for baseline scores. Results Mean baseline HAQ-S and SF-36 PCS scores were 1.02±0.56 and 33.5±8.0, respectively. Mean baseline WPAI domain scores were 57.1±24.7 (activity impairment), 9.8±20.9 (absenteeism), 43.3±25.7 (presenteeism), and 47.5±27.9 (work impairment). At Week 12, clinical improvement was greater in pts on ADA vs. PBO; 47 of 179 pts with non-missing data (38% of ADA vs. 15% of PBO pts, p Conclusions Among pts in ABILITY-1, both ASAS40 response and ASDAS inactive disease state were associated with meaningful improvements in PROs. References Sieper J, et al. Ann Rheum Dis. 2013;72(6):815–22. Revicki D, et al. Arthritis Rheum. 2012;64(10 Suppl):S1-1216. van der Heijde DM, et al. Arthritis Res Ther. 2009;11(4):R124. Sandborn WJ, et al. Gut. 2007; 56(Suppl 3):A159, Abstract MON-G-355. Acknowledgements Eric Bertelsen, PhD, of Arbor Communications provided medical writing and editing services in the development of this abstract. Financial support for these services was provided by AbbVie. Disclosure of Interest D. van der Heijde Consultant for: AbbVie, Amgen, Aventis, Bristol-Myers Squibb, Centocor, Pfizer, Roche, Schering-Plough, UCB, Wyeth, A. Joshi Shareholder of: AbbVie, Employee of: AbbVie, M. Mittal Shareholder of: AbbVie, Employee of: AbbVie, A. Pangan Shareholder of: AbbVie, Employee of: AbbVie, N. Chen Shareholder of: AbbVie, Employee of: AbbVie, K. Betts Employee of: Analysis Group, which received payment from AbbVie to assist with the research, C. Qi Employee of: Analysis Group, which received payment from AbbVie to assist with the research, Y. Bao Shareholder of: AbbVie, Employee of: AbbVie DOI 10.1136/annrheumdis-2014-eular.2376