02 September 2017 : Clinical Research
The Italian Pharmacovigilance Program: An Observational Study of Adverse Effects of Natalizumab in Multiple Sclerosis Therapy
Sabrina Giacoppo1CDEF, Maria Ruscica2AB, Luigi Maria Grimaldi2ABG, Placido Bramanti1AG, Emanuela Mazzon1AB*DOI: 10.12659/MSM.903301
Med Sci Monit 2017; 23:4230-4240
Abstract
BACKGROUND: This study shows the results of a regional pharmacovigilance program on Natalizumab therapy in relapsing-remitting multiple sclerosis (RR-MS) patients after 3 years of experience.
MATERIAL AND METHODS: The primary objectives of this study were to estimate the incidence of expected and unexpected adverse effects correlated to Natalizumab therapy in a cohort of 88 RR-MS patients from Sicily, Italy, and to investigate the procedures adopted by the physicians to minimize the risk of developing severe adverse reactions correlated to Natalizumab therapy. Secondary objectives of this study were to evaluate the effectiveness of Natalizumab therapy for a careful examination of the risk/benefit ratio and to assess the actions undertaken in case of adverse reactions.
RESULTS: Among 88 RR-MS patients, 55.68% did not report any type of adverse reaction, 35.22% showed expected adverse reactions (58.70% slight, 22.58% moderate, and 19.35% severe), and 9.10% showed unexpected adverse effects (62.50% slight, 25.00% moderate, and 12.50% severe). Approximately 4.54% of the patients treated with Natalizumab interrupted the therapy. Overall, among all patients, 56.62% showed ameliorated condition, 32.53% had stable disease condition, and 10.85% worsened.
CONCLUSIONS: We provide a short overview of evidence, which may be useful to better characterize the efficacy and potential adverse effects correlated to Natalizumab therapy.
Keywords: Antibodies, Monoclonal, Humanized, Drug-Related Side Effects and Adverse Reactions, Multiple Sclerosis, Relapsing-Remitting, pharmacovigilance
Editorial
01 February 2025 : Editorial
Editorial: Current Approaches to Screening for Lung Cancer in Smokers and Non-SmokersDOI: 10.12659/MSM.948255
Med Sci Monit 2025; 31:e948255
In Press
Clinical Research
Pre- and Post-Surgical MRI Analysis of Levator Ani in Pelvic Organ Prolapse Patients: A Single-Center StudyMed Sci Monit In Press; DOI: 10.12659/MSM.945993
Clinical Research
Comparative Impact of Kinesio Taping and Post-Isometric Muscle Relaxation on Pain and Myofascial Mechanics ...Med Sci Monit In Press; DOI: 10.12659/MSM.945376
Clinical Research
Surgical Efficacy in Varicocele Ligation with Ephedrine-Assisted Blood Pressure ControlMed Sci Monit In Press; DOI: 10.12659/MSM.946234
Clinical Research
Retrospective Study to Compare Injury Patterns and Associations in 170 Patients Following Electric Scooter ...Med Sci Monit In Press; DOI: 10.12659/MSM.947155
Most Viewed Current Articles
17 Jan 2024 : Review article 6,968,277
Vaccination Guidelines for Pregnant Women: Addressing COVID-19 and the Omicron VariantDOI :10.12659/MSM.942799
Med Sci Monit 2024; 30:e942799
16 May 2023 : Clinical Research 701,791
Electrophysiological Testing for an Auditory Processing Disorder and Reading Performance in 54 School Stude...DOI :10.12659/MSM.940387
Med Sci Monit 2023; 29:e940387
01 Mar 2024 : Editorial 25,442
Editorial: First Regulatory Approvals for CRISPR-Cas9 Therapeutic Gene Editing for Sickle Cell Disease and ...DOI :10.12659/MSM.944204
Med Sci Monit 2024; 30:e944204
28 Jan 2024 : Review article 20,020
A Review of IgA Vasculitis (Henoch-Schönlein Purpura) Past, Present, and FutureDOI :10.12659/MSM.943912
Med Sci Monit 2024; 30:e943912