Poster Presentations
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ABSTRACTS
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Poster Presentations P.134 Infliximab Treatment Adverse Events in 78 Patients with Rheumatoid Arthritis ´ 1 L. Alesso,2 A.M. Bertoli,1 M. Baravale,1 Z. Betelu,1 D. Calas, R. Herrera,2 L. Morales,1 I. Strusberg,1 A.M. Strusberg1 ´ ´ 1 Centro Reumatologico Strusberg, Cordoba, Argentina; 2 Public Health School Pharmacovigilance Center, School of ´ ´ Medicine, Cordoba National University, Cordoba, Argentina Background: Tumor Necrosis Factor antagonists are biological agents used in Rheumatoid Arthritis (RA) and other immune-mediated inflammatory diseases that can increase patient’s susceptibility to infections and cancer. Anaphylaxis is also an important side effect. Aim: Estimating Adverse Events (AE) incidence in 78 patients with RA treated with infliximab, assessing AE nature and seriousness, looking for related adverse effects (infections, anaphylaxis, cancer), and determining if AE caused treatment discontinuation Patients and methods: Seventy-eight RA diagnosed patients (13 men, 65 women; age range 25 y.-76 y; average age 51.32 y) treated with at least two consecutive doses of infliximab from an out-patient private centre were retrospectively studied during a period ranged from 1 to 74 months (follow-up mean time: 2.42 years) between August 2000 and December 2006. Total follow-up period was 188,5 patient/year. Clinical variables (time from diagnosis, anatomical stage, rheumatoid factor, sedimentation rate, number of swollen and tender joints) and pharmacological variables (methotrexate and glucocorticoids doses at first infliximab dose, infliximab treatment length and compliance, occurrence and causes of treatment discontinuation) were studied. Anti-flu and anti-pneumococcal vaccines were administered. No systematic cancer screening was performed. Clinical signs, symptoms and laboratory tests guided AE search; complementary tests were performed if necessary. Results: Fifty-four out of 78 patients (69.23 %, 54/78) presented EA during infliximab treatment. Forty-one patients (52.56 % of total 41/78; and 76% of patients who presented AE, 41/54) presented mild infections. There were three severe infection cases (3.84% of total, 3/78 and 5.55% of patients who presented AE): bacterial pneumoniae, septic arthritis and post-surgical infection. Twenty patients (25.64 % of total and 37% of patients who presented AE) presented allergic Adverse Drug Reactions (ADR).Treatment discontinuation was ADR caused in 14 patients (17.94% of patients total number and 25.92% of patients who presented AE). ADR were the main reason for stopping infliximab treatment (38.88%, 14/36). Among patients who discontinued, we documented 16 anaphylactic events (rash, giant urticaria, mild bronchoconstriction, acute severe lumbar pain, etc) and 3 severe infections. There were no clinical cases of tuberculosis, drug-induced lupus, demyelinating disease or cancer. No patient died. Conclusion: The most frequent AE in this cohort was mild infections, followed by anaphylactic reactions. Se
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