SAT0163 LOW CARDIOVASCULAR EVENT RATE DURING TOCILIZUMAB TREATMENT IN THE NON-INTERVENTIONAL STUDY ICHIBAN

Background: Rheumatoid arthritis (RA) patients (pts) have a 1.5 to 2-fold increased risk for cardiovascular (CV) events and CV mortality [1]. Traditional risk factors as well as underlying disease, including therapy with glucocorticoids (GC) contribute to the increased CV risk. Typical risk factors include age, male sex, hypertension, adiposity, and diabetes mellitus [2]. Objectives: The exploratory post-hoc analysis of the non-interventional study (NIS) ICHIBAN (NCT 01194401, final dataset) investigated the CV risk of RA pts during intravenous tocilizumab (TCZ) treatment over 2 years. Methods: Data of 3164 pts (total) who received at least one dose of TCZ were available. Analysis focuses on the CV events myocardial infarction (MI), coronary heart disease (CHD), and stroke. The incidence of respective treatment-emergent adverse events (TEAEs) (according to MedDRA preferred term) and/or AEs of special interest (AESIs, recorded by the investigator) was evaluated. The following risk factors (at baseline [BL]) were analysed: sex, age, smoking status, RA duration, DAS28, CDAI, seropositivity, CRP, comorbidities, previous therapies, concomitant therapies, and combinations thereof. Results: At BL, pts were more frequently female (74.8%), on average 55.5 years old, had a mean BMI of 26.9 kg/m2, and mean RA duration of 9.7 years. 72% of pts suffered from comorbidities (37% hypertension, 17% osteoporosis, 10% diabetes mellitus).The majority (66.4%) was pre-treated with TNF inhibitors, while 30.0% received csDMARDs only. Co-medication was csDMARDs in 50.7% of pts and GC in 80.6%. Overall, 46.6% of pts experienced at least 1 TEAE. The rate of pts who experienced a CV event was 0.8% for MI, 0.4% for CHD, and 0.6% for stroke (Table 1). For patients with typical risk factors a higher rate of CV events was observed: male pts, pts of higher age, pts who were anti-CCP negative, and pts who suffered from diabetes mellitus, coronary heart disease (only for CHD), asthma, and renal insufficiency (see Table 2 for details; exploratory p-values are given). Interestingly, no differences were observed between subgroups of smoking status, RA duration, DAS28, CDAI, CRP, previous therapies, concomitant therapies, and combinations thereof (data not shown). Conclusion: In the NIS ICHIBAN, with its long-lasting patient population, the rate of CV events during TCZ treatment was comparable to former investigations [1, 3, 4]. In pts with the typical risk characteristics at BL, i.e. male sex, higher age, diabetes mellitus, and CHD, higher rates of CV events were observed. In addition, increased rates were also found in anti-CCP negative pts and in pts with asthma or renal insufficiency References [1] Pujades-Rodriguez M, et al. PLoS ONE 11(3): doi:10.1371/journal. pone.0151245. [2] Lowel H, et al. Robert Koch Institut. Heft 33. [3] Mohan S, et al. ACR2017-550. [4] Giles JT, et al. ACR2016-969. Disclosure of Interests: Christof Specker Grant/research support from: Boehringer, Chugai, GSK, Roche, Consultant for: AbbVie, Boehringer Ingelheim, Chugai, Lilly, Novartis, Sobi, UCB, Speakers bureau: AbbVie, Celgene, Chugai, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Annette Alberding Grant/research support from: This study was supported by Roche Pharma AG (Grenzach-Wyhlen, Germany) and Chugai Pharma Europe Ltd. (Frankfurt am Main, Germany). Financial support went directly to Dr Alberding’s employer: Internal Rheumatology Department, St. Josef Hospital, Wuppertal, Germany., Martin Aringer Grant/research support from: Roche, Consultant for: AstraZeneca and Eli Lilly, Gerd Rudiger Burmester Consultant for: Roche, Sanofi-Genzyme, Speakers bureau: Roche, Sanofi-Genzyme, Michael W. Hofmann Employee of: Chugai Pharma Europe Ltd.., Peter Kastner Grant/research support from: Roche, Herbert Kellner Grant/research support from: Roche, Consultant for: Roche, Christina Luig Employee of: Roche Pharma, AG., Frank Moosig Grant/research support from: Roche, Maren Sieburg Grant/research support from: Roche, Hans-Peter Tony Grant/research support from: Roche, Consultant for: Roche Pharma, Abbvie, BMS, Chugai, Janssen, Novartis, Sanofi, Lilly, Speakers bureau: Roche Pharma, Abbvie, BMS, Chugai, Janssen, Novartis, Sanofi, Lilly., Gerhard Fliedner Grant/research support from: Roche