ANTITNF-A IN PATIENTS WITH EITHER RHEUMATOID ARTHRITIS OR SPONDYLARTHRITIS AND CONCURRENT CRONIC HEPATITIS C: A RETROSPECTIVE RECORD REVIEW ON SAFETY

Background: Anti tumor necrosis factor-α (antiTNF-α) agents seem to be an attractive treatment option in patients with rheumatic diseases and concurrent hepatitis C infection (HCV). A few reports (1-7) on a small number of patients have been so for addressed to investigate the safety of TNF-α antagonists in patients with either rheumatoid arthritis (RA) or spondylarthritis (SA) and concurrent HCV infection. Objectives: To assess safety in clinical practice of antiTNFα - Etanercept (ETA), Adalimumab (ADA), Infliximab (IFX) - in patients with RA or SA and concurrent chronic hepatitis C. Methods: This study is based on a retrospective data collection from 350 outpatients, receiving antiTNF-α treatment, with RA or SA and documented seropositivity for HCV, observed from 2003 to 2009. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), albumin, protrombin time (PT) and alkaline phosphatase (ALP) were used as markers of hepatic iniury. Hepatitis C viral load (UI/mL) was used as marker of viral replication. Data were collected before antiTNF-α treatment and during follow-up (baseline, after 3, 6, 12 months of antiTNF-α treatment and at the last follow up visit or at the time of discontinuation of treatment) and then compared. Continuous variables were expressed as the mean ± standard deviation (SD). Groups differences were tested for significance by Fisher's exact probability test and by means of ANOVA test, where appropriate. A value of p<0.05 was considered statistically significant. Results: Out of the 350 patients investigated, 8 [5 with RA (age 55.8±15.8 SD years; time duration 5.4±4.4 SD years); 3 with SA (age 49.7±11.7 SD years; time duration 18.6±14.0 years)] were concurrently infected with HCV; 1 only had a basal (<2 UNL) elevation in both AST and ALT levels. All of the 8 patients had been treated with TNF-α antagonists (4 out of the 153 treated with ETA; 2 out of 107 treated with ADA; 2 out of the 90 treated with IFX) for 34.1±22.6 SD months. An elevation in ALT/AST levels ≥ 3 UNL was detected in 1 patient who was undergoing IFX for spondylarthritis. A similar increase in AST/ALT levels was detected in none of the remaining 170 patients, who where undergoing antiTNF-α treatment without concurrent methotrexate administration (p=0.03). HCV viral load remained stable, with some light fluctuations, in all patients. Conclusion: Our results support the safety of TNF-α antagonists in patients with inflammatory arthritis and concurrent HCV infection (8). Nevertheless, a need for a periodical monitoring throughout the treatment period emerges from the detection of elevate transaminases levels in 1 out of the 8 patients, who was not treated with any other hepatotoxic drug. References: 1. Li S, et al. Clin Rheumatol. 2009; 28:787-791. 2. Massarotti M, et al. Int J Immunopathol Pharmacol. 2009; 22(2):547-549. 3. Ferri C, et al. J Rheumatol. 2008; 35:1944-1949. 4. Roux CH, et al. Rheumatology. 2006; 45:1294-1297. 5. Parke FA, et al. Arthritis Rheum. 2004; 51(5):800-804. 6. Oniankitan O, et al. J Rheumatol. 2004; 31:107-109. 7. Peterson JR, et al. Ann Rheum Dis. 2003; 62:1078-1082. 8. Furst DE, et al. Ann Rheum Dis. 2010; 69 Suppl.1: i2-i29. Disclosure of Interest: None declaredCitation: Annals of the Rheumatic Diseases, volume 69, supplement 3, year 2010, page 681Session: Rheumatoid arthritis – anti-TNF therapy (Abstracts accepted for publication )