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Abstract Number: 2368

Risk of Diverticulitis and Gastro-Intestinal Perforation in Rheumatoid Arthritis Treated with Tocilizumab Compared to Rituximab and Abatacept: A Prospective Propensity-matched Cohort Study

Claire Rempenault1, Cédric Lukas 1, Bernard Combe 2, Isabelle Pane 3, Xavier Mariette 4, Jacques-Eric Gottenberg 5 and Jacques Morel 1, 1Department of Rheumatology, Montpellier University Hospital, Montpellier, France, Montpellier, Languedoc-Roussillon, France, 2CHU Montpellier, Montpellier University, Montpellier, France, 3Centre de Recherche en Epidémiologie et Statistiques, INSERM U1153, Centre d'Épidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Descartes University, Paris, France., Paris, Ile-de-France, France, 4Center for Immunology of Viral Infections and Autoimmune Diseases, Assistance Publique – Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, Le Kremlin-Bicêtre, Université Paris Sud, INSERM, Paris, France, 5Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: gastrointestinal complications, Rheumatoid arthritis (RA), rituximab and abatacept, Tocilizumab

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Session Information

Date: Tuesday, November 12, 2019

Session Title: RA – Treatments Poster III: Safety and Outcomes

Session Type: Poster Session (Tuesday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Several studies have reported an increased risk of gastro-intestinal perforation (GIP) in rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ) compared to conventional synthetic disease modifying anti rheumatic drugs (csDMARDs) or TNF inhibitors (TNFis) (1–3). However, a recent study did not find an increased risk of GIP with TCZ compared to TNFis and even compared to others biologic-DMARDs (bDMARDs), namely rituximab (RTX) and abatacept (ABA) (4). The aim of our study was to compare the risk of diverticulitis and GIP in RA patients treated with TCZ compared to RTX and ABA using a propensity-matched analysis.

Methods: We conducted a study of patients with TNFis refractory RA, prospectively followed in 3 observational French registries evaluating the effectiveness and safety of RTX (Autoimmunity and Rituximab (AIR)), ABA (Orencia and Rheumatoid Arthritis (ORA)), and TCZ (REGistry–RoAcTEmra (REGATE)). Adult patients with RA according to the 1987 ACR criteria, initiating intravenous treatment with RTX, ABA, or TCZ were enrolled from 107 clinical centers between September 2005 and August 2013 (5). Using a propensity score approach, we compared the risk of diverticulitis or GIP during treatment with TCZ vs RTX and ABA. Pearson Chi-squared analysis and multivariable logistic regression were used to evaluate correlation between different risk factors and the onset of diverticulitis or GIP among TCZ, RTX or ABA (the latter 2 pooled). We also retrospectively collected the outcome of these specific adverse events and compared the clinical presentation by treatment.

Results: Forty-one diverticulitis and 19 GIP occurred in 4501 RA patients (patient’s characteristics are shown in table 1) (corresponding incidences of 0.027 and 0.012 per 1000 person-years). Based on inverse probability weighting, there was an increased risk of GIP due to diverticulitis (5.66 [2.63-12.18], p< 0.0001) in the TCZ group vs RTX and ABA. There was also an increased risk of diverticulitis and GIP but not GIP due to another etiology. In multivariate analysis, age was associated with an increased risk of diverticulitis (1.03/year [1.01-1.06], p=0.03) in all patients, and history of neoplasia was associated with an increased risk of GIP in patients treated with TCZ (5.04 [1.03-24.65], p=0.04). Compared to RTX and ABA, diverticulitis and GIP during TCZ occurred earlier after the last perfusion (24.5+/-18.4 vs 58.6+/-49.2 days, p=0.01), with usually atypical clinical presentation (slow transit in 30% vs 0, p=0.04) and milder biological inflammatory markers  at the time of the event (hemoglobin: 13.9+/-1.8 vs 10.6+/-2.8 g/dL, p=0.01; platelets: 251583+/-85976 vs 371500+/-68066/mm3, p=0.04; and C-reactive protein: 31.2+/- 58.4 vs 88.2+/-89.6 mg/L, p=0.005).

Conclusion: TCZ was associated with an increased risk of diverticulitis, GIP and GIP due to diverticulitis, but not those caused by another etiology, compared to RTX and ABA. Our study confirms an increased risk of GIP in RA patients treated with TCZ and could be explained by an increased risk of diverticulitis with misleading clinical presentation.


Table

Table 1: Characteristics of patients including in the French registries
TCZ=tocilizumab ; RTX=rituximab ; ABA=abatacept ; DM=diabetes mellitus ; RA=rheumatoid arthritis ; RF=rheumatoid factor ; ACPA= anti-citrullinated protein antibodies ; csDMARDs=conventional synthetic disease modifying anti rheumatic drugs ; CS=corticosteroids; SD=standard deviation


Disclosure: C. Rempenault, None; C. Lukas, None; B. Combe, AbbVie, 5, BMS, 5, 8, Chugai, 5, 8, Eli Lilly, 5, Eli Lilly and Company, 5, 8, Gilead, 5, 8, Gilead Sciences, Inc., 5, 8, Janssen, 5, Lilly, 5, 8, MSD, 2, 5, 8, Novartis, 5, Pfizer, 2, 5, 8, Roche, 2, 5, 8, Roche-Chugai, 5, 8, Sanofi, 5, UCB, 5, USD, 5; I. Pane, None; X. Mariette, Biogen, 2, Bristol-Myers Squibb, 5, GlaxoSmithKline, 5, Janssen, 5, LFB Pharmaceuticals, 5, OSE Immunotherapeutics, 2, Pfizer, 2, 5, UCB Pharma, 5, 8; J. Gottenberg, Abbvie, 8, BMS, 2, 5, Lilly, 5, 8, Pfizer, 2, 5, Roche, 8, Sanofi-Genzyme, 5, 8, UCB, 5, 8; J. Morel, None.

To cite this abstract in AMA style:

Rempenault C, Lukas C, Combe B, Pane I, Mariette X, Gottenberg J, Morel J. Risk of Diverticulitis and Gastro-Intestinal Perforation in Rheumatoid Arthritis Treated with Tocilizumab Compared to Rituximab and Abatacept: A Prospective Propensity-matched Cohort Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/risk-of-diverticulitis-and-gastro-intestinal-perforation-in-rheumatoid-arthritis-treated-with-tocilizumab-compared-to-rituximab-and-abatacept-a-prospective-propensity-matched-cohort-study/. Accessed January 27, 2021.
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