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Abstract Number: 960

The Risk of Gastrointestinal Perforations Associated with Biologic Disease-Modifying Anti-Rheumatic Drugs Used in Rheumatoid Arthritis: A Nationwide Swedish Cohort Study

Andrei Barbulescu1, Thomas Frisell1, Johan Askling2 and Bénédicte Delcoigne1, 1Clinical Epidemiology Unit, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden, 2Unit of Clinical Epidemiology, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Adverse events, Biologic drugs, Gastrointestinal complications and rheumatoid arthritis (RA)

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Session Information

Date: Sunday, October 21, 2018

Session Title: 3S108 ACR Abstract: RA–Treatments II: Safety (958–963)

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose:

Gastrointestinal (GI) perforations occur more often than expected in patients with RA. Reports indicate that tocilizumab may be associated with an increased risk of GI perforations compared to synthetic DMARDs (1) or to TNF inhibitors (TNFi) (2). Replications are needed, and there is little data on other biologic DMARDs. In this analysis, we compare GI perforation rates among RA patients exposed to rituximab, abatacept, tocilizumab, or TNFi.

Methods:

In this register-based cohort study we included all Swedish RA patients, with follow-up from 2010 to 2016. All initiations of treatment with TNFi, rituximab, abatacept, or tocilizumab were extracted from the Swedish rheumatology register (SRQ); each patient could contribute to several exposure cohorts. Follow-up under each exposure episode ended with a GI perforation event or at censoring by emigration, death, treatment switch or discontinuation, or end of study period. GI perforations were identified in the Swedish National Patient Register as any inpatient or outpatient diagnosis with an International Statistical Classification of Diseases and Related Health Problems (ICD) 10 code from a predefined list. Crude incidence rates were tabulated for each treatment cohort and relative effects were estimated as adjusted hazard ratios (HR) in multivariable Cox regressions, conditioning on baseline characteristics measured at the start of each episode (demographic, disease activity, co-medication, disease history).

Results:

We found some evidence for outcome relevant channeling, with patients starting abatacept or rituximab more often having a history of diverticular disease or GI perforation, and some differences in age and co-medication (Table 1). Table 2 presents observed person-time, number of events (95% of which were lower GI perforations), crude rates and adjusted comparisons. The crude GI perforation rate was lowest in the TNFi, and highest in the abatacept cohort. None of the adjusted comparisons of each non-TNFi biologic with TNFi biologics yielded hazard ratios significantly different from 1. 

Conclusion:

We could not replicate an increased rate of GI perforations for tocilizumab. Taking measured channeling of treatment into account, none of the non-TNFi biologics showed an increased risk compared to TNFi biologics. Effects of residual or unmeasured factors cannot be excluded.

References:

1. Strangfeld A, et al. Ann Rheum Dis 2017;76:504–510.

2. Xie F, et al. Arthritis Rheumatol 2016;68:2612–2617.

 

Table 1. Baseline characteristics of each exposure cohort

Characteristic

TNFi

Rituximab

Abatacept

Tocilizumab

Treatment episodes (N)

14536

2965

2188

2041

Mean age (years)

56.65

62.33

59.41

57.21

Females (%)

76.20

75.95

80.80

79.47

Mean DAS28

4.58

4.94

4.88

5.12

Mean disease duration

12.02

15.34

14.61

13.16

Synthetic DMARD1 (%)

73.21

68.19

63.57

57.77

NSAIDs1 (%)

33.93

34.07

36.61

39.81

Steroids1 (%)

47.38

57.91

58.89

57.13

Diverticular Disease2 (%)

2.90

4.65

5.12

3.43

GI perforation3 (%)

0.16

0.34

0.73

0.20

1Use of conventional synthetic DMARDs, NSAIDs or steroids within 31 days around the start of the episode (Yes/No).

2Any diagnosis within 5 years before the start of the episode (Yes/No).

3Any diagnosis within 1 year before the start of the episode (Yes/No).

 

 

Table 2. Crude incidence rates (per 1000 person-years) and adjusted Hazard Ratios.

Cohort

No. events

Follow-up

(person years – py)

Crude Incidence Rate (/1000 py)

Hazard Ratio1 (95% Confidence Interval)

TNFi

40

26108.27

1.53

Reference

Rituximab

17

7305.85

2.33

0.75 (0.41 to 1.37)

Abatacept

15

3637.22

4.12

1.49 (0.79 to 2.79)

Tocilizumab

11

3898.77

2.82

1.15 (0.57 to 2.35)

1Adjusted for: sex, age, education, line of biologic therapy, disease parameters (rheumatoid factor, duration, HAQ, DAS28), co-medication (synthetic DMARDs, NSAIDs, steroids), disease history (cancer, COPD, diabetes, diverticular disease, IBD, GI-perforation) and start of treatment year.

 


Disclosure: A. Barbulescu, None; T. Frisell, None; J. Askling, AbbVie Inc., 2,BMS, 2,MSD, 2,Eli Lilly and Co., 2,Pfizer, Inc., 2,Roche, 2,Samsung Bioepis, 2,Eli Lilly and Co., 5,Novartis, 5,Pfizer, Inc., 5,UCB, Inc., 2; B. Delcoigne, None.

To cite this abstract in AMA style:

Barbulescu A, Frisell T, Askling J, Delcoigne B. The Risk of Gastrointestinal Perforations Associated with Biologic Disease-Modifying Anti-Rheumatic Drugs Used in Rheumatoid Arthritis: A Nationwide Swedish Cohort Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/the-risk-of-gastrointestinal-perforations-associated-with-biologic-disease-modifying-anti-rheumatic-drugs-used-in-rheumatoid-arthritis-a-nationwide-swedish-cohort-study/. Accessed March 21, 2023.
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