Safety of anti-tumor necrosis factor-α therapy in patients with rheumatoid arthritis and chronic hepatitis C virus infection

Objective. The prevalence of concurrent rheumatoid arthritis (RA) and hepatitis C virus (HCV) infection is probably underestimated because of the increasing spread of this virus worldwide, especially in developing countries. In these patients, anti-tumor necrosis factor-α (anti-TNF-α) therapy may aggravate hepatitis and increase viremia. We evaluated the safety of these treatments, which remain controversial. Methods. Thirty-one HCV-positive patients (23 women, 8 men, mean age 59 ± 13 yrs, mean disease duration 13 ± 11.5 SD yrs) with active RA [Disease Activity Score 28 (DAS28) > 3.2] unresponsive to conventional therapies were treated with TNF-α blockers (infliximab 11, etanercept 17, adalimumab 3) at standard dosages. Safety and efficacy were evaluated at the third month of treatment and at the patient's last observation. Results. A significant clinical-serological improvement was recorded at the 3-month reevaluation. Mean values of patients' assessment of general health on visual analog scale (range 0-100) decreased from 69 ± 29 (SD) to 35 ± 27 (p <0.0001), Ritchie index from 21.6 ± 13.9 to 10.1 ± 3.7 (p <0.0001), erythrocyte sedimentation rate from 36 ± 25 to 28 ± 22 mm/h (p = 0.04), and DAS28 from 5.2 ± 1.6 to 2.78 ± 1.3 (p <0.0001); a DAS28 <2.6 was recorded in 15/31 (48%) patients. At the last observation 19 patients (61%) continued TNF-α blockers, and the observed benefits persisted after 22 ± 11 months of followup. Mean values of transaminases (ALT) and HCV viral load showed no significant variations; TNF-α blockers were discontinued in only one patient because of persistently elevated ALT not correlated to the variations of HCV viremia; this latter increased significantly (≥ 2 log10) in 4 cases. Conclusion. Previous observations had suggested the safety of TNF-α blockers for treatment of RA in patients with concurrent HCV infection. Given the clinical-therapeutic implications, our results support the safety of TNF-α blockers in patients with HCV, provided there is close monitoring of clinical and virological data (mainly ALT and HCV viremia). The Journal of Rheumatology