RESEARCH - Safety of anti-TNF therapy in patients with RA and chronic HCV

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J Rheumatol. 2008 Aug 1. [Epub ahead of print]

Safety of Anti-Tumor Necrosis Factor-alpha Therapy in Patients with

Rheumatoid Arthritis and Chronic Hepatitis C Virus Infection.

Ferri C, Ferraccioli G, Ferrari D, Galeazzi M, Lapadula G, Montecucco

C, Triolo G, Valentini G, Valesini G.

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.

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-alpha (anti-TNF-alpha) 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-alpha

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-alpha 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-alpha 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-alpha blockers for treatment of RA in patients with concurrent HCV

infection. Given the clinical-therapeutic implications, our results

support the safety of TNF-alpha blockers in patients with HCV,

provided there is close monitoring of clinical and virological data

(mainly ALT and HCV viremia).

PMID: 18688917

http://www.ncbi.nlm.nih.gov/pubmed/18688917

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