ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1603

Safety of Biologic and Non-Biologic Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Veterans with Rheumatoid Arthritis and Chronic Hepatitis C Infection

Jeffrey R. Curtis1,2, Mary Jane Burton3, Shou Yang1, Lang Chen1, Ted R. Mikuls4, Jasvinder A. Singh2, Kevin L. Winthrop5 and John Baddley2,6, 1University of Alabama at Birmingham, Birmingham, AL, 2Birmingham VAMC, Birmingham, AL, 3Jackson VAMC, Jackson, MS, 4University of Nebraska Medical Center, Omaha, NE, 5Oregon Health and Science University, Portland, OR, 6Medicine, University of Alabama at Birmingham, Birmingham, AL

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: ,

Session Information

Date: Monday, November 9, 2015

Title: Rheumatoid Arthritis - Clinical Aspects Poster II

Session Type: ACR Poster Session B

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

Background/Purpose: Among patients with rheumatoid arthritis and hepatitis C virus (HCV) infection, the impact of biologic and nonbiologic DMARD therapy on hepatotoxicity has received limited study.

Methods: Using 1997-2011 national data from the US Veteran’s Health Administration, we identified a cohort of 38,433 rheumatologist-diagnosed RA patients. Eligible patients had HCV infection (defined by detectable HCV RNA) and subsequently initiated a new biologic (infliximab, adalimumab, etanercept; rituximab) or nonbiologic (hydroxychloroquine, sulfasalazine, methotrexate, leflunomide) DMARD that they had never been on previously. Patients were required to have a baseline ALT <66 IU/mL and quantifiable HCV RNA within 90 days prior to starting biologic/DMARD therapy (defined as “index date”) as well as ALT and HCV RNA measurement within 1 year after index date. Patients with HIV and hematologic malignancy were excluded. Patients could contribute more than one treatment episode provided they switched to a new biologic/DMARD they had not previously used, or switched to a previously used biologic/DMARD they had not used in the past year. The primary outcome of interest was hepatotoxicity, defined as ALT elevation ≥100 IU/L (corresponding to 3x ULN for women and 2.5x ULN for men) or increase in HCV RNA by one log, and was examined within the first year of biologic/DMARD use. Current exposure was defined as-treated based on day supply (injection biologics) or usual dosing intervals (infused biologics).Results were reported as the cumulative incidence of patients achieving pre-defined hepatotoxicity at 3, 6 and 12-months post-biologic exposure.

Results: 

RA patients with HCV (n=748) were identified and contributed 1097 biologic/DMARD treatment episodes. Mean age was 59.8 years and 77.3% were male. Nearly half of biologic users (47.4%) were also prescribed methotrexate and/or leflunomide. Overall, ALT elevations were uncommon, with 37 hepatotoxicity events (ALT ≥100 IU/L or HCV RNA increase by one log) occurring within 12 months (3.4%). Treatment episodes with biologics demonstrated increased frequency of hepatotoxicity (ALT ≥100 IU/L or HCV RNA increase by one log) than nonbiologics (4.8% vs 2.3%, p=0.028). Most hepatotoxicity events occurred within 6 months of DMARD initiation (29/37, 78%).

Table:  Cumulative hepatotoxicity events among RA patients with HCV within 12 months of initiating biologic/nonbiologic DMARDs

Cumulative Hepatotoxicity Events

Drug

Number exposed

3-months

6-months

12-months

ADA

180

3(1.7%)

7(3.9%)

8(4.4%)

ETA

179

4(2.2%)

7(3.9%)

10 (5.6%)

INF

48

0(0%)

2(4.2%)

2(4.2%)

RIT

28

1(3.6%)

1(3.6%)

1 (3.6%)

ABA

22

0(0%)

1(4.6%)

1(4.6%)

LEF

91

1(1.1%)

2(2.2%)

2(2.2%)

MTX

156

0(0%)

4(2.6%)

6(3.9%)

HCQ

272

2(0.7%)

2(0.7%%)

4(1.5%)

SSZ

121

3(2.5%)

3(2.5%)

3(2.5%)

Total

1097

14(1.3%)

29(2.6%)

37(3.4%)

ADA=adalimumab; ETA=etanercept; INF=infliximab; RIT=rituximab, ABA=abatacept;

LEF=leflunomide; MTX=methotrexate; SSZ-HCQ=sulfasalazine/hydroxychloroquine

Conclusion: In US Veterans with HCV and RA receiving biologic and nonbiologic DMARDs, the frequency of treatment-related hepatotoxicity (ALT ≥100 IU/L) was low, with a higher frequency observed in treatment episodes with current biologic use. The majority of hepatotoxicity events occurred within 6 months after biologic/DMARD initiation.

Disclosure: J. R. Curtis, Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie, 2,Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie, 5; M. J. Burton, None; S. Yang, None; L. Chen, None; T. R. Mikuls, None; J. A. Singh, None; K. L. Winthrop, BMS, 2,AbbVie, BMS, UCB, Amgen, 5; J. Baddley, Pfizer, Astellas, Merck, 5,BMS, 2.

To cite this abstract in AMA style:

Curtis JR, Burton MJ, Yang S, Chen L, Mikuls TR, Singh JA, Winthrop KL, Baddley J. Safety of Biologic and Non-Biologic Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Veterans with Rheumatoid Arthritis and Chronic Hepatitis C Infection [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/safety-of-biologic-and-non-biologic-disease-modifying-antirheumatic-drug-dmard-therapy-in-veterans-with-rheumatoid-arthritis-and-chronic-hepatitis-c-infection/. Accessed .

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