ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1443

Adverse Drug Reactions Due to Disease Modifying Drugs in a Cohort of Patients with Incident Rheumatoid Arthritis

Zulema Rosales Rosado1,2, Dalifer Freites Núñez2, Cristina Lajas Petisco1, Esperanza Pato Cour1, Leticia Leon2, Judit Font Urgelles1, Juan A Jover Jover1 and Lydia A Alcazar2, 1Rheumatology, Hospital Clínico San Carlos, Madrid, Spain, 2Instituto de Investigación Sanitaria San Carlos (IdISSC), Madrid, Spain

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: , , ,

Session Information

Date: Monday, November 6, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster II: Prognostic Factors, Imaging and Miscellaneous Reports

Session Type: ACR Poster Session B

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

Background/Purpose: There is a well-known risk of developing adverse drug reactions (ADR) in rheumatology due, mainly, to the Disease Modifying Drugs (DMARD) used. After more than twenty years using DMARD, there is no doubt about their efficacy in rheumatoid arthritis (RA), but it is necessary to increase our knowledge of their ADR, especially those that lead to discontinuation in real life. Purpose: to describe the incidence and characteristics of ADR to DMARD in patients with incident RA as well as the factors related to their development.

Methods: An observational longitudinal study was conducted. Patients: all recent onset RA patients diagnosed between April 15th 2007 and 31stJune 2011 followed in outpatient clinic at Hospital Clinico San Carlos until December 31st 2016, which used any DMARD (synthetic and biologic). Primary outcome: development of an ADR that required discontinuation of the DMARD (moderate: discontinuation; severe: discontinuation and hospitalization or death as a result of the ADR). Incidence rates of discontinuation (IR) per 100 patient-years were estimated using survival techniques with their respective 95% confidence interval [CI]. Comparisons between associated factors were run by Cox bivariate and multivariate regression models. Results were expressed by hazard ratio (HR) and [CI].

Results: We included 1054 courses of DMARD treatment in 405 patients (2277.9 patient-years). 78.3% were women with a mean age at diagnosis of 57±15 years. Median time to the first DMARD was 0.3 [±0.6] days. 16.3% of patients were taking biological DMARD, 73.3% were using monotherapy and 89% were taking corticoids. There were 369 ADR in 212 patients, 88.9% of them moderate. Gastrointestinal was the most frequent cause of ADR (26.3%), followed by infections (12.2%). Incidence rates are shown in table 1. In the multivariate analysis (table 2) after adjusting by age and sex, number of concomitant DMARD was directly related to more risk. Regarding type of DMARD, Abatacept had the highest risk of ADR development (HR: 4.9[2.1-11.2]) compared to the other drugs followed by Gold (HR: 1.6[1-2.6]) and Leflunomide (HR: 1.4[1.1-1.9]). Methotrexate was the safest drug compared with the others (0.6[0.5-0.8]).

Conclusion: The IR of ADR estimated was 16.2%, being gastrointestinal the main cause followed by infections. We have found differences in discontinuation rates among DMARD due to ADR, being Abatacept, Gold and Leflunomide the drugs with the highest risk. Methotrexate is a protective factor for the development of ADR. Caution should be taken in patients receiving combined therapy and with certain comorbidities.

TABLE 1 patient-years n IR 95%CI

Global

Women

Men

2277.9

1835.4

442.5

369

296

73

16.2

16.1

16.5

14.6-17.9

14.4-18.1

13.1-20.7

By therapy regimen

Monotherapy

Doyble therapy

Triple therapy

1609.5

568.9

99.4

200

132

37

12.4

23.2

37.2

10.8-14.3

19.6-27.5

26.9-51.4

By tipe of DMARD

Synthetic

Biological

2048.3

229.5

326

43

15.9

18.7

14.3-17.7

13.9-25.3

By drug

Abatacept

Adalimumab

Antimalarials

Azathioprine

Certolizumab

Etanercept

Golimumab

Infliximab

Leflunomide

Methotrexate

Gold

Rituximab

Sulfasalazine

8.3

81.5

749.7

19

16

65.2

9.1

18.4

340.4

1463.5

83.6

26.3

154

5

10

157

3

4

12

5

6

85

206

33

1

45

60.6

12.3

20.9

15.7

24.8

18.4

54.9

32.7

25

14.1

39.5

3.8

29.2

25.2-145.5

6.6-22.8

17.9-24.5

5.1-48.8

9.3-66.2

10.5-32.4

22.9-131.9

14.7-72.7

20.2-30.9

12.3-16.1

28-55.5

0.5-27

21.8-39.1

TABLE 2 Hazard ratio CI 95% p

Monotherapy

Double therapy

Triple therapy

1

2

4.2

–

1.5-2.5

2.6-6.8

–

0

0

Biologics vs Synthetic DMARD 0.8 0.5-1.3 0.4
Congestive heart failure 1.8 1.2-2.7 0.002
Liver disease 2 1.2-3.3 0.012
Cancer 1.3 0.9-1.8 0.083
Disclosure: Z. Rosales Rosado, None; D. Freites Núñez, None; C. Lajas Petisco, None; E. Pato Cour, None; L. Leon, None; J. Font Urgelles, None; J. A. Jover Jover, None; L. A. Alcazar, None.

To cite this abstract in AMA style:

Rosales Rosado Z, Freites Núñez D, Lajas Petisco C, Pato Cour E, Leon L, Font Urgelles J, Jover Jover JA, Alcazar LA. Adverse Drug Reactions Due to Disease Modifying Drugs in a Cohort of Patients with Incident Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/adverse-drug-reactions-due-to-disease-modifying-drugs-in-a-cohort-of-patients-with-incident-rheumatoid-arthritis/. Accessed .

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