Abstracts of the 14th Congress of ECCO – European Crohn’s and Colitis Organisation S329 population. Our aim was to evaluate the rate of infiximab-related IAE in elderly IBD patients. Methods: All adult patients in the ENEIDA registry (a large, pro- spectively maintained database of the Spanish Working Group in IBD–GETECCU) who received a frst course of infiximab treat- ment were identifed. Patients were selected in two cohorts regard- ing the age at the beginning of infiximab treatment: over 60 years, and between 18 and 50 years of age. The rates of IAE recorded in the ENEIDA database (infusion reactions, delayed hypersensitivity, oedema, allergy, anaphylaxis, psoriasis, lupus-like syndrome) were compared, as well as the rate of secondary loss of response (SLR). Results: We included 939 (12%) patients who started infiximab over 60 years and 6844 (88%) patients below 50 years. The rate of IAE (15% vs. 15%, ns) and treatment withdrawal due to IAE (13% vs. 12%, ns) was similar in both groups. Neither differences were observed according to IAE: infusion reactions (8.3% vs. 8.2%), late hypersensitivity (1.4% vs. 1.2%), paradoxical psoriasis (0.9% vs. 1.4%) and drug-induced lupus erythematosus (0.7% vs. 0.6%). Patients below 50 years were signifcantly more often treated with concomitant immunosuppressants (57% vs. 48.1% >60 years, p < 0.05). In the multi-variate analysis, combination with immunosup- pressants (OR 0.741; 95% CI 0.64–8.5, p < 0.05) and female sex (OR 1.8; 95% CI 1.6–2.1, p < 0.05) were the only independent pre- dictors to develop IAE. The rate of SLR was also similar in both study groups (20% vs. 21%). Combination therapy with immuno- suppressants was the unique risk factor to develop SLR (OR 0.85; CI 95% 0.73 to 0.98, p = 0.021). Conclusions: Elderly IBD patients who start treatment with infixi- mab have a similar risk of developing IAE and SLR than younger patients. From this point of view, elderly would beneft from combi- nation therapy. P438 Lupus-like reactions in patients with inflammatory bowel disease treated with anti- TNFs are rare but insidious adverse events: data from a large single-centre cohort F. S. Macaluso, C. Sapienza, M. Ventimiglia, M. Cottone, A. Orlando IBD Unit, ‘Villa Sofa-Cervello’ Hospital, Palermo, Italy Background: The occurrence of lupus-like reactions (LLRs) may complicate the management of patients with infammatory bowel disease (IBD) treated with anti-TNFs. However, very few data on the incidence, predictors, and clinical outcomes of LLRs have been reported. We aimed to describe all these features in a large cohort of IBD patients treated with anti-TNF drugs Methods: All records of consecutive patients who started a treat- ment with an anti-TNF from January 2006 to June 2018 were ret- rospectively reviewed. Patients were defned as having LLR by the presence of immunologic abnormalities (positivity for ANA and/or anti-ds-DNA), along with clinical features that included at least two of the following: arthralgia, fatigue, fever, cutaneous manifestations, or serositis, which had a clear temporal association with exposure to the anti-TNFs, and resolved without recurrence once the drug was discontinued. Univariable and multiple Cox proportional hazard models were used to estimate the association between all variables at baseline and occurrence of LLRs. Results: In total, 760 patients (1059 total treatments with anti- TNFs) were included. Participants contributed a total of 2863.5 person-years of follow-up, during which 16 cases of LLRs (2.1% of patients) were reported, with an incidence rate of 5.6 per 1000 person-years. Female gender and being former smokers were more prevalent in the LLR group (75.0% vs. 44.1%, p = 0.02; and 18.8% vs. 5.4%, p = 0.037, respectively), with a hazard ratio of 3.86 (95% CI: 1.21–12.38; p = 0.023) and 4.42 (95% CI: 1.20–16.24; p = 0.025), respectively, at Cox regression analysis adjusted for possi- ble confounders. LLRs occurred after a mean of 12.0 ± 9.7 months of therapy with anti-TNFs. Antinuclear antibodies were universally positive, and 10 out 16 (62.5%) patients had also anti-ds-DNA. Arthropathy was the most frequent symptom (87.5%), followed by fatigue (81.2%), and fever (31.2%). Three cases presented with a concomitant autoimmune hepatitis-like syndrome. The diagnosis of LLR was further confrmed by a re-challenge with the culprit agent in half of the cases. All LLRs resolved following discontinuation of the drug after a mean of 8.1 ± 4.2 weeks, even if 10 patients required corticosteroids for the control of symptoms. Five patients (31.2%) were switched to a second anti-TNFs, and one of them developed a second LLR. Conclusions: In this very large cohort of patients treated with anti- TNFs, LLRs were rare adverse events, more common in women and former smokers. Clinical features are non-specifc and insidious. All LLRs resolved following discontinuation of the drug, but the use of corticosteroids was required in most of the cases. P439 Effectiveness and safety of the sequential use of a second and third anti-TNF agent in patients with inflammatory bowel disease: results from the ENEIDA registry M. J. Casanova* 1 , M. Chaparro 1 , M. Mínguez 2 , E. Ricart 3 , C. Taxonera 4 , S. García-López 5 , J. Guardiola 6 , A. López-San Román 7 , E. Iglesias 8 , B. Beltrán 9 , B. Sicilia 10 , M. I. Vera 11 , J. Hinojosa 12 , S. Riestra 13 , E. Domènech 14 , X. Calvet 15 , J. L. Pérez- Calle 16 , M. D. Martín-Arranz 17 , X. Aldeguer 18 , M. Rivero 19 , D. Monfort 20 , J. Barrio 21 , M. Esteve 22 , L. Márquez 23 , R. Lorente 24 , E. García-Planella 25 , L. de Castro 26 , F. Bermejo 27 , O. Merino 28 , A. Rodríguez-Pérez 29 , P. Martínez-Montiel 30 , M. Van Domselaar 31 , G. Alcaín 32 , M. Domínguez-Cajal 33 , C. Muñoz 34 , F. Gomollón 35 , L. Fernández-Salazar 36 , M. F. García-Sepulcre 37 , I. Rodríguez- Lago 38 , A. Gutiérrez 39 , F. Argüelles-Arias 40 , C. Rodriguez 41 , G. E. Rodríguez 42 , L. Bujanda 43 , J. Llaó 44 , P. Varela 45 , L. Ramos 46 , J. M. Huguet 47 , P. Almela 48 , P. Romero 49 , M. Navarro-Llavat 50 , Á. Abad 51 , P. Ramírez-de la Piscina 52 , A. J. Lucendo 53 , E. Sesé 54 , R. E. Madrigal 55 , M. Charro 56 , A. García-Herola 57 , R. Pajares 58 , S. Khorrami 59 , J. P. Gisbert 1 1 Hospital Universitario de La Princesa, IIS-IP , Universidad Autónoma de Madrid and CIBEREHD, Gastroenterology Unit, Madrid, Spain, 2 Hospital Clínico Universitario de Valencia, Gastroenterology Unit, Valencia, Spain, 3 Hospital Clínic i Provincial, CIBEREHD and IDIBAPS, Gastroenterology Unit, Barcelona, Spain, 4 Hospital Universitario Clínico San Carlos, Gastroenterology Unit, Madrid, Spain, 5 Hospital Universitario Miguel Servet and CIBEREHD, Gastroenterology Unit, Zaragoza, Spain, 6 Hospital Universitario de Bellvitge, Gastroenterology Unit, Barcelona, Spain, 7 Hospital Universitario Ramón y Cajal, Gastroenterology Unit, Madrid, Spain, 8 Hospital Universitario Reina Sofía, Gastroenterology Unit, Córdoba, Spain, 9 Hospital Universitario y Politécnico La Fe and CIBEREHD, Gastroenterology Unit, Valencia, Spain, Downloaded from https://academic.oup.com/ecco-jcc/article/13/Supplement_1/S329/5300969 by guest on 23 May 2023