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P608 Systematic literature review of observational studies that assess the effectiveness of biologic drugs in the treatment of extra-intestinal manifestations in inflammatory bowel disease

L. Peyrin-Biroulet1, G. Van Assche2, D. Gomez-Ulloa3, L. Garcia-Alvarez3, N. Lara3, C. Black4, S. Kachroo*4

1Lorraine University, Gastroenterology Department, Vandoeuvre, France, 2University Hospitals Leuven, Department of Gastroenterology, Leuven, Belgium, 3IMS Health, Real-World Evidence Solutions, Barcelona, Spain, 4Merck & Co, Inc, Centre for Observational and Real-World Evidence (CORE), Rahway, New Jersey, United States

Background

A significant portion of inflammatory bowel disease (IBD) patients show associated extra-intestinal manifestations (EIMs). Evidence suggests that new biologic drugs for the management of IBD may improve EIM outcomes. The objective of this systematic literature review (SLR) is to assess previously published non-interventional studies (NIS) investigating the effectiveness of biologic drugs in the treatment of EIMs in IBD.

Methods

A SLR was conducted in PubMed, Embase, and Cochrane, in October 2015. Main inclusion criteria comprised adults with IBD, use of a biologic drug (infliximab [IFX], adalimumab [ADA], certolizumab pegol [CZP], golimumab [GOL], vedolizumab [VED], and natalizumab [NAT]), evolution of EIMs (ie, musculoskeletal, metabolic bone disease [MBD], cutaneous, ocular, hepatobiliary, vascular, and haematologic), NIS, and English language. Key exclusion criteria were clinical trials, conference abstracts, and NIS including less than 10 patients. Data were abstracted from indexed publications.

Results

Included were 13 NIS (914 IBD patients analysed): 12 assessed the effectiveness of biologic drugs in one single type of EIM (6 studies in MBD, 2 in anaemia; 2 in pyoderma gangrenosum [PG]; 2 in haemostatic parameters); and 1 in several EIMs (cutaneous and musculoskeletal). All studies included Crohn’s disease (CD) patients, and 5 also included ulcerative colitis (UC) patients. Effectiveness of IFX was assessed in all studies; ADA in 2; and CZP in 1. IFX was associated with improved outcomes in markers for bone formation in CD in short-term studies (range follow-up 4–16 weeks) and with improved outcomes in bone mineral density in long-term studies (2 years mean follow-up). Anti-TNF therapy (IFX, ADA, and CZP) provided haematologic response in anaemic CD and UC patients in the short term (14 weeks, 67% response) and in the long term (1 year, 34% response), combined with iron therapy (94% patients). IFX and ADA provided definitive cure in > 90% of IBD patients presenting with PG. IBD patients treated with IFX showed significant improvement in haemostatic parameters in the short term (up to 14 weeks). IFX provided clinical response in 80% of IBD patients with cutaneous and/or musculoskeletal manifestations. Studies assessing effectiveness of GOL, VED, or NAT were not identified.

Conclusion

Our SLR indicates that anti-TNF drugs are an effective alternative for the treatment of certain EIMs associated with IBD (musculoskeletal, MBD, cutaneous, vascular, and haematologic). Most evidence available relates to the use of IFX in EIMs in CD patients. Data on the effectiveness of the remaining biologic drugs in EIMs are scarce.