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Safety of Anti-Tumor Necrosis Factor-α Therapy in Patients with Rheumatoid Arthritis and Chronic Hepatitis C Virus Infection CLODOVEO FERRI, GIANFRANCO FERRACCIOLI, DANIELA FERRARI, MAURO GALEAZZI, GIOVANNI LAPADULA, CARLOMAURIZIO MONTECUCCO, GIOVANNI TRIOLO, GABRIELE VALENTINI, and GUIDO VALESINI, for the GISEA Group ABSTRACT. 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 patientfs last observation. Results. A significant clinical-serological improvement was recorded at the 3-month reevaluation. Mean values of patientsf 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). (J Rheumatol First Release Aug 1 2008) Key Indexing Terms: RHEUMATOID ARTHRITIS From the Rheumatic Disease Unit, University of Modena and Reggio Emilia, Modena/Reggio Emilia; Rheumatic Disease Unit, Catholic University of the Sacred Heart, Rome; Rheumatic Disease Unit, University of Siena, Siena; Rheumatic Disease Unit, University of Bari, Bari; Rheumatic Disease Unit, University of Pavia, Pavia; Rheumatic Disease Unit, University of Palermo, Palermo; Rheumatic Disease Unit, University of Napoli 2, Napoli; and Rheumatic Disease Unit, Sapienza University of Rome, Rome, Italy. Supported by Gruppo Italiano Studio Early Arthritis (Italian Study Group for Early Arthritis) C. Ferri, MD, Chair of Rheumatology, Rheumatic Disease Unit, University of Modena and Reggio Emilia; G. Ferraccioli, MD, Chair of Rheumatology, Rheumatic Disease Unit, Catholic University of the Sacred Heart; D. Ferrari, MD, Fellow, Rheumatic Disease Unit, University of Modena and Reggio Emilia; M. Galeazzi, MD, Chair of Rheumatology, Rheumatic Disease Unit, University of Siena; G. Lapadula, MD, Chair of Rheumatology, Rheumatic Disease Unit, University of Bari; C. Montecucco, MD, Chair of Rheumatology, Rheumatic Disease Unit, University of Pavia; G. Triolo, MD, Chair of Rheumatology, Rheumatic Disease Unit, University of Palermo; G. Valentini, MD, Chair of Rheumatology, Rheumatic Disease Unit, University of Napoli 2; G. Valesini, MD, Chair of Rheumatology, Rheumatic Disease Unit, Sapienza University of Roma. Address reprint requests to Prof. C. Ferri, Cattedra di Reumatologia, Policlinico, Via del Pozzo, 71, 41100 Modena, Italy. E-mail: clferri@unimo.it Accepted for publication April 10, 2008. |
