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Abstract Number: 541

Prevalence of Sjögren’s Syndrome in Patients with RA Enrolled in a Large Observational US Registry

Leslie R Harrold1, Ying Shan2, Sabrina Rebello2, Neil Kramer3, Sean E. Connolly4, Evo Alemao4, Sheila Kelly4, Tammy Curtice4, Joel Kremer5 and Elliot Rosenstein3, 1University of Massachusetts, Worcester, MA, 2Corrona, LLC, Southborough, MA, 3Overlook Medical Center, Institute for Rheumatic & Autoimmune Diseases, Summit, NJ, 4Bristol-Myers Squibb, Princeton, NJ, 5Albany Medical College and the Center for Rheumatology, Albany, NY

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: registry and rheumatoid arthritis (RA), Sjogren's syndrome

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Session Information

Date: Sunday, October 21, 2018

Title: Rheumatoid Arthritis – Diagnosis, Manifestations, and Outcomes Poster I: Comorbidities

Session Type: ACR Poster Session A

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

Background/Purpose: Sjögren’s syndrome is a known co-existing autoimmune disease in patients with RA, but its prevalence and impact on RA are poorly understood. The aims of this study were to assess the prevalence of secondary Sjögren’s syndrome (sSS) and to compare the baseline characteristics of patients with RA, with and without Sjögren’s syndrome, in a national sample of patients with RA.

Methods: We identified adult patients with rheumatologist-diagnosed RA (ARA 1987 or ACR/EULAR 2010 criteria) from a large observational US registry (Corrona RA), with at least one visit assessing the presence of sSS (yes/no) between Apr 22, 2010 and Feb 28, 2018. Patients who had an sSS diagnosis were compared with those who never had a diagnosis. In those without a diagnosis, patients had to be enrolled for at least 12 months to ensure complete data capture. The index date was the date of first capture of sSS diagnosis (sSS patients) or first visit in patients with a negative sSS diagnosis (non-sSS patients). Patients with missing sSS information were excluded. The primary outcome was the unadjusted prevalence of Sjögren’s syndrome in patients with RA. Baseline characteristics and the prevalence by RA disease duration were assessed by sSS status.

Results: A total of 24,528 patients met the inclusion criteria, of whom 7870 (32.1%) had a diagnosis of sSS. The unadjusted overall rate for the prevalence of Sjögren’s syndrome in patients with RA was 0.30 (95% CI: 0.29, 0.31). Compared with patients without sSS, patients with sSS were more likely to be older, female and seropositive (both cyclic citrullinated peptide positive and RF+), and had a longer duration of RA, higher disease activity (CDAI score), and a higher incidence of co-morbidities (cardiovascular disease, malignancies and serious infections), erosive disease and subcutaneous nodules at the index date (Table 1). The rate of sSS increased with increasing RA disease duration (Table 2).

Conclusion: This study suggests that patients with sSS and RA have a higher disease burden than those with RA alone. sSS was associated with seropositivity, more severe RA, and a greater incidence of other extra-articular manifestations and co-morbidities. A higher prevalence of sSS was observed as the duration of RA increases.

Professional medical writing and editorial assistance was provided by Claire Line, PhD, at Caudex, and was funded by Bristol-Myers Squibb.

Table 1. Baseline Characteristics at Index Date

Patients with sSS + RA

(n=7870)

Patients with RA only

(n=16,658)

Age, years, mean (SD)

62.5 (11.9)

59.2 (13.1)

Sex, female

6617 (84.4)

12,229 (73.8)

Duration of RA, years, mean (SD)

13.6 (11.0)

9.5 (9.2)

Co-morbidities

CV disease*

Malignancy†

Serious infections‡

1219 (15.5)

1223 (15.5)

795 (10.1)

1710 (10.3)

1821 (10.9)

845 (5.1)

Cyclic citrullinated peptide positive, n/m (%)

1999/3420 (58.5)

4076/7451 (54.7)

RF+, n/m (%)

2983/4296 (69.4)

6338/9492 (66.8)

Erosive disease, n/m (%)

2480/6650 (37.3)

4230/12,406 (34.1)

Subcutaneous nodules, n/m (%)

2700/7869 (34.3)

2886/16,640 (17.3)

CDAI, mean (SD)

13.4 (12.8)

11.3 (11.9)

Number of prior biologics/tsDMARDs

0

1

≥2

2583 (32.8)

2656 (33.7)

2631 (33.4)

7593 (45.6)

5592 (33.6)

3473 (20.8)

Number of prior csDMARD

0

1

≥2

367 (4.7)

2984 (37.9)

4519 (57.4)

1704 (10.2)

8016 (48.1)

6938 (41.6)

Data are n (%) unless otherwise stated

*History of coronary artery disease, myocardial infarction, coronary heart failure requiring hospitalization, acute coronary syndrome, unstable angina, cardiac revascularization procedure, cardiac arrest, ventricular arrhythmia, stroke, transient ischemic attack or other CV event

†History of lung cancer, breast cancer, lymphoma, skin cancer (melanoma and squamous) or other cancer

‡Infection required hospitalization or IV treatment

csDMARD=conventional synthetic DMARD; CV=cardiovascular; n/m=number of patients by total number of patients in the analysis; sSS=secondary Sjögren’s syndrome; tsDMARD=targeted synthetic DMARD

Table 2. Prevalence of Sjögren’s Syndrome in Patients with RA by Disease Duration

Disease duration, years

n (%)

0–1

533 (14.4)

2–3

637 (23.2)

4–5

732 (28.9)

6–10

1538 (29.8)

>10

3637 (38.8)


Disclosure: L. R. Harrold, Corrona, LLC, 1,Pfizer, 2,Roche, Bristol-Myers Squibb, 5,Corrona, LLC, University of Massachusetts Medical School, 3; Y. Shan, Corrona, LLC, 3; S. Rebello, Corrona, LLC, 3; N. Kramer, None; S. E. Connolly, Bristol-Myers Squibb, 1, 3; E. Alemao, Bristol-Myers Squibb, 1, 3; S. Kelly, Bristol-Myers Squibb, 1, 3; T. Curtice, Bristol-Myers Squibb, 1, 3; J. Kremer, Corrona, LLC, 1, 3,AbbVie, Bristol-Myers Squibb, Genentech, Lilly, Novartis, Pfizer, 2,Genentech, Inc., 8; E. Rosenstein, Amgen, Bristol-Myers Squibb, Horizon, 5,Up-To-Date, 7,AbbVie, Amgen, Bristol-Myers Squibb, 8.

To cite this abstract in AMA style:

Harrold LR, Shan Y, Rebello S, Kramer N, Connolly SE, Alemao E, Kelly S, Curtice T, Kremer J, Rosenstein E. Prevalence of Sjögren’s Syndrome in Patients with RA Enrolled in a Large Observational US Registry [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/prevalence-of-sjogrens-syndrome-in-patients-with-ra-enrolled-in-a-large-observational-us-registry/. Accessed .
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