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1. Post-marketing of disease modifying drugs in multiple sclerosis: an exploratory analysis of gender effect in interferon beta treatment

Author

Trojano, M, Pellegrini, F, Paolicelli, D, Fuiani, A, Zimatore, Gb, Tortorella, C, Simone, Il, Patti, F, Ghezzi, A, Portaccio, E, Rossi, P, Pozzilli, C, Salemi, G, Lugaresi, A, Bergamaschi, R, Millefiorini, E, Clerico, Marinella, Lus, G, Vianello, M, Avolio, C, Cavalla, P, Iaffaldano, P, Direnzo, V, D'Onghia, M, Lepore, V, Livrea, P, Comi, G, Amato, Mp, Italian Multiple Sclerosis Database Network Group, Trojano, M., Pellegrini, F., Paolicelli, D., Fuiani, A., Zimatore, G., Tortorella, C., Simone, I., Patti, F., Ghezzi, A., Portaccio, E., Rossi, P., Pozzilli, C., Salemi, G., Lugaresi, A., Bergamaschi, R., Millefiorini, E., Clerico, M., Lus, Giacomo, Vianello, M., Avolio, C., Cavalla, P., Iaffaldano, P., Direnzo, V., D'Onghia, M., Lepore, V., Livrea, P., Comi, G., Amato, M., ITALIAN MULTIPLE SCLEROSIS DATABASE NETWORK, . ., Trojano M, Pellegrini F, Paolicelli D, Fuiani A, Zimatore GB, Tortorella C, Simone IL, Patti F, Ghezzi A, Portaccio E, Rossi P, Pozzilli C, Salemi G, Lugaresi A, Bergamaschi R, Millefiorini E, Clerico M, Lus G, Vianello M, Avolio C, Cavalla P, Iaffaldano P, Direnzo V, D'Onghia M, Lepore V, Livrea P, Comi G, Amato MP, M Trojano, F Pellegrini, D Paolicelli, A Fuiani, GB Zimatore, C Tortorella C, IL Simone, F Patti, A Ghezzi, E Portaccio, P Rossi, C Pozzilli, G Salemi, A Lugaresi, and on behalf of Italian Multiple Sclerosis Database Network (MSDN) group

Subjects
Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Propensity score, Disease, gender, interferon beta, multiple sclerosis, observational study, propensity score, Lower risk, Severity of Illness Index, Multiple sclerosis, Interferon beta, Gender, Observational study, Propensity score, Cohort Studies, Disability Evaluation, Young Adult, Sex Factors, gender, multiple sclerosis, treatment, interferon, Double-Blind Method, Internal medicine, Observational study, medicine, Confidence Intervals, Odds Ratio, Product Surveillance, Postmarketing, Humans, Immunologic Factors, Multiple sclerosi, Proportional Hazards Models, Expanded Disability Status Scale, Proportional hazards model, business.industry, Multiple sclerosis, Drug Administration Routes, Interferon-beta, medicine.disease, Interferon beta, Surgery, Neurology, Italy, Cohort, Propensity score matching, Regression Analysis, Settore MED/26 - Neurologia, Female, Neurology (clinical), business
Abstract

Background: There are a few and conflicting results from randomised controlled trials (RCTs) pertaining to the influence of gender in response to currently used disease modifying drugs in Multiple Sclerosis (MS). Observational studies may be especially valuable for answering effectiveness questions in subgroups not studied in RCTs. Objective: To conduct a post-marketing analysis aimed to evaluate the gender effect on Interferon beta (IFN beta) treatment response in a cohort of relapsing (RR) MS patients. Methods: A cohort of 2570 IFN beta-treated RRMS was prospectively followed for Lip to 7 years in 15 Italian MS Centers. Cox proportional hazards regression models were used to assess gender differences for risk of reaching 1st relapse and risk of progression by I point on Expanded Disability Status Scale (EDSS) score. Gender effects were also explored by a propensity score (PS) matching algorithm, and a tree-growing technique. Results: The multivariate Cox Regression analyses showed that male patients had a significant (p = 0.0097) lower risk for 1st relapse and a trend (p = 0.0897) for a higher risk to reach I point EDSS progression than females. The PS matched multivariate Cox Regression confirmed these results. The RECPAM analysis showed that male sex conferred a significant reduction in the risk for 1st relapse (HR = 0.86; 95% Cl = 0.76-0.98; p = 0.0226) in the subgroup with a low pre-treatment number of bouts, and a significant increase in the risk for I point EDSS progression (HR = 1.33; 95% Cl: 1.00-1.76; p

Published
2009

2. Pregnancy and fetal outcomes after interferon-β exposure in multiple sclerosis

Author

Amato, M. P., Portaccio, E., Ghezzi, A., Hakiki, B., Zipoli, V., Martinelli, V., Moiola, L., Patti, F., La Mantia, L., Mancardi, G. L., Solaro, C., Tola, M. R., Pozzilli, C., De Giglio, L., Totaro, R., Lugaresi, A., Di Tommaso, V., Paolicelli, D., Marrosu, M. G., Comi, G., Pellegrini, F., Trojano, M., Siracusa, G., Rizzo, A., Zaffaroni, M., Radaelli, M., Milanese, C., Protti, A., Spreafico, C., Marazzi, R., Cavalla, P., Masera, S., Bergamaschi, R., Capello, E., Molinari, F., Caniatti, L., Granella, F., Immovilli, P., Annunziata, P., De Santi, L., Plewnia, K., Guidi, L., Bartolozzi, M. L., Mazzoni, M., De Luca, Giovanna, Carrozzo, A., D'Onghia, M., Musu, L., Cavallaro, T., Amato, M. P., Portaccio, E., Ghezzi, A., Hakiki, B., Zipoli, V., Martinelli, V., Moiola, L., Patti, F., La Mantia, L., Mancardi, G. L., Solaro, C., Tola, M. R., Pozzilli, C., De Giglio, L., Totaro, R., Lugaresi, A., Di Tommaso, V., Paolicelli, D., Marrosu, M. G., Comi, G., Pellegrini, F., Trojano, M., Siracusa, G., Rizzo, A., Zaffaroni, M., Radaelli, M., Milanese, C., Protti, A., Spreafico, C., Marazzi, R., Cavalla, P., Masera, S., Bergamaschi, R., Capello, E., Molinari, F., Caniatti, L., Granella, F., Immovilli, P., Annunziata, P., De Santi, L., Plewnia, K., Guidi, L., Bartolozzi, M. L., Mazzoni, M., De Luca, Giovanna, Carrozzo, A., D'Onghia, M., Musu, L., Cavallaro, T., and DIPARTIMENTO DI SCIENZE BIOMEDICHE E NEUROMOTORIE

Subjects
Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Fetal Disease, Abortion, Follow-Up Studie, Cohort Studies, Pregnancy, Multiple Sclerosi, medicine, Abortion, Spontaneou, Humans, Prospective Studies, Fetus, treatment, business.industry, Obstetrics, multiple sclerosis, treatment, pregnancy, interferon, Infant, Newborn, Pregnancy Outcome, interferon, Odds ratio, Interferon-beta, medicine.disease, Confidence interval, Surgery, Abortion, Spontaneous, Fetal Diseases, Prospective Studie, Fetal Weight, In utero, Propensity score matching, Female, Neurology (clinical), Cohort Studie, business, Cohort study, Follow-Up Studies, Human
Abstract

none 23 no Objective: To assess pregnancy and fetal outcomes after in utero exposure to interferon-beta (IFN beta) in all pregnancies occurring in women with multiple sclerosis (MS) during the study period, with a specific focus on the risk of spontaneous abortion. Methods: In this cohort study, data were gathered through a standardized, semi-structured interview. Patients who discontinued IFN beta less than 4 weeks from conception (exposed) were compared with those who had discontinued the drug at least 4 weeks from conception or who were never treated (not exposed). Possible confounders were handled through multivariate analyses adjusted for propensity score (PS). Results: We collected data on 396 pregnancies in 388 women, 88 classified as exposed (mean exposure 4.6 +/- 5.8 weeks). IFN beta exposure was not associated with an increased risk of spontaneous abortion (PS-adjusted odds ratio [OR] 1.08, 95% confidence interval [CI] 0.4 to 2.9, p = 0.88), although it was associated with both lower baby weight (PS-adjusted beta -113.8, p < 0.0001) and length (PS-adjusted beta -1.102, p < 0.0001). Proportion of spontaneous abortion in exposed patients fell within the range expected for the Italian population in the same period. IFN beta exposure (PS-adjusted OR 2.11, 95% CI 1.18 to 3.78, p = 0.012) and cesarean delivery were the only predictors of preterm delivery. In the exposed group, we did not observe any significant fetal complications, malformations, or developmental abnormalities over a median follow-up of 2.1 years. Conclusions: Our findings point to the relative safety of IFN beta exposure times of up to 4 weeks and can assist neurologists facing therapeutic decisions in women with MS with a pregnancy plan. Neurology (R) 2010;75:1794-1802 none Amato MP; Portaccio E; Ghezzi A; Hakiki B; Zipoli V; Martinelli V; Moiola L; Patti F; La Mantia L; Mancardi GL; Solaro C; Tola MR; Pozzilli C; De Giglio L; Totaro R; Lugaresi A; Di Tommaso V; Paolicelli D; Marrosu MG; Comi G; Pellegrini F; Trojano M MS Study Group of the Italian Neurological Society; De Luca G Amato MP; Portaccio E; Ghezzi A; Hakiki B; Zipoli V; Martinelli V; Moiola L; Patti F; La Mantia L; Mancardi GL; Solaro C; Tola MR; Pozzilli C; De Giglio L; Totaro R; Lugaresi A; Di Tommaso V; Paolicelli D; Marrosu MG; Comi G; Pellegrini F; Trojano M MS Study Group of the Italian Neurological Society; De Luca G

Published
2010

3. Real-life impact of early interferon beta therapy in relapsing multiple sclerosis

Author

Trojano, M., Pellegrini, F., Paolicelli, D., Fuiani, A., Zimatore, G., Tortorella, C., Simone, I., Patti, F., Ghezzi, A., Zipoli, V., Rossi, P., Pozzilli, C., Salemi, G., Lugaresi, A., Bergamaschi, R., Millefiorini, E., Clerico, M., Lus, G., Vianello, M., Avolio, C., Cavalla, P., Lepore, V., Livrea, P., Comi, G., Amato, M., Di Monte, E., Iaffaldano, P., Direnzo, V., D'Onghia, M., Lo Fermo, S., Messina, S., D'Amico, E., Rizzo, A., Zaffaroni, M., Portaccio, E., Martinelli, V., Prosperini, L., Onesti, E., Aridon, P., D'Amelio, M., Ragonese, P., De Luca, G., Farina, D., Di Tommaso, V., Tavazzi, E., Bargiggia, V., Crivelli, P., Cortese, A., Di Rezze, S., Durastanti, V., Alfieri, G., Rosellini, I., Modesto, M., Notariello, M., Tortorella, P., Trojano M, Pellegrini F, Paolicelli D, Fuiani A, Zimatore GB, Tortorella C, Simone IL, Patti F, Ghezzi A, Zipoli V, Rossi P, Pozzilli C, Salemi G, Lugaresi A, Bergamaschi R, Millefiorini E, Clerico M, Lus G, Vianello M, Avolio C, Cavalla P, Lepore V, Livrea P, Comi G, Amato MP, Di Monte E, Iaffaldano P, Direnzo V, D'Onghia M, Lo Fermo S, Messina S, D'Amico E, Rizzo A, Zaffaroni M, Portaccio E, Martinelli V, Prosperini L, Onesti E, Aridon P, D'Amelio M, Ragonese P, De Luca G, Farina D, Di Tommaso V, Tavazzi E, Bargiggia V, Crivelli P, Cortese A, Di Rezze S, Durastanti V, Alfieri G, Rosellini I, Modesto M, Notariello M, Tortorella P, Trojano, M, Pellegrini, F, Paolicelli, D, Fuiani, A, Zimatore, Gb, Tortorella, C, Simone, Il, Patti, F, Ghezzi, A, Zipoli, V, Rossi, P, Pozzilli, C, Salemi, G, Lugaresi, Alessandra, Bergamaschi, R, Millefiorini, E, Clerico, M, Lus, G, Vianello, M, Avolio, C, Cavalla, P, Lepore, V, Livrea, P, Comi, G, and Amato, Mp

Subjects
Adult, Male, Time Factors, Multiple Sclerosis, Interferon beta, Interferon-beta, Cohort Studies, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Treatment Outcome, observational study, multiple sclerosis, interferon, treatment, early, Sickness Impact Profile, Multiple Sclerosi, Quality of Life, Humans, Female, Settore MED/26 - Neurologia, Prospective Studies, Follow-Up Studies
Abstract

OBJECTIVE: Recent findings support greater efficacy of early vs. delayed interferon beta (IFNbeta) treatment in patients with a first clinical event suggestive of multiple sclerosis (MS). We aimed to evaluate the effectiveness of early IFNbeta treatment in definite relapsing-remitting MS (RRMS) and to assess the optimal time to initiate IFNbeta treatment with regard to the greatest benefits on disability progression. METHODS: A cohort of 2,570 IFNbeta-treated RRMS patients was prospectively followed for up to 7 years in 15 Italian MS Centers. A Cox proportional hazards regression model adjusted for propensity score (PS) quintiles was used to assess differences between groups of patients with early vs. delayed IFNbeta treatment on risk of reaching a 1-point progression in the Expanded Disability Status Scale (EDSS) score, and the EDSS 4.0 and 6.0 milestones. A set of PS-adjusted Cox hazards regression models were calculated according to different times of treatment initiation (within 1 year up to within 5 years from disease onset). A sensitivity analysis was performed to assess the robustness of findings. RESULTS: The lowest hazard ratios (HRs) for the three PS quintiles-adjusted models were obtained by a cutoff of treatment initiation within 1 year from disease onset. Early treatment significantly reduced the risk of reaching a 1-point progression in EDSS score (HR = 0.63; 95% CI = 0.48-0.85; p < 0.002), and the EDSS 4.0 milestone (HR = 0.56; 95% CI = 0.36-0.90; p = 0.015). Sensitivity analysis showed the bound of significance for unmeasured confounders. INTERPRETATION: Greater benefits on disability progression may be obtained by an early IFNbeta treatment in RRMS.

Published
2009

4. Mitoxantrone prior to interferon beta-1b in aggressive relapsing multiple sclerosis: a 3-year randomised trial

Author

Edan, G, Comi, G, Le Page, E, Leray, E, Rocca, Ma, Filippi, M, French–Italian Mitoxantrone Interferon beta 1b Trial Group Trojano, M, Paolicelli, D, D'Onghia, M, Rumbach, L, Clavelou, P, Aufauvre, D, Moreau, T, Amato, Mp, Portaccio, E, Ghezzi, A, Mancardi, A, Vermersch, P, Hautecoeur, P, De Sèze, J, Magy, L, Vallat, Jm, Confavreux, C, Vukusic, S, Ionescu, I, Blanc, S, Pelletier, J, Malikova Klemina, I, Ranjeva, Jp, Debouverie, M, Pittion, S, Lebrun, C, Roullet, E, Heinzlef, O, Gout, O, Lubetzki, C, Stankoff, B, Tourbah, A, Veillard, D, Warter, Jm, Tranchant, C, Berry, I, Brassat, D, Clanet, M, Durelli, Luca, Clerico, Marinella, Service de Neurologie [Rennes] = Neurology [Rennes], CHU Pontchaillou [Rennes], Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), École des Hautes Études en Santé Publique [EHESP] (EHESP), Edan, G, Comi, Giancarlo, Le Page, E, Leray, E, Rocca, Ma, Filippi, Massimo, French Italian Mitoxantrone Interferon beta 1b Trial, Group, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR)

Subjects
Oncology, Male, medicine.medical_treatment, Gadolinium, Severity of Illness Index, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Clinical endpoint, 030212 general & internal medicine, 10. No inequality, Brain, Immunosuppression, Magnetic Resonance Imaging, 3. Good health, Psychiatry and Mental health, Methylprednisolone, Drug Therapy, Combination, Female, Immunosuppressive Agents, medicine.drug, Interferon beta-1b, Adult, medicine.medical_specialty, Multiple Sclerosis, Neuroimaging, Drug Administration Schedule, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, medicine, Humans, Immunologic Factors, Mitoxantrone, Expanded Disability Status Scale, business.industry, Multiple sclerosis, Interferon-beta, medicine.disease, Surgery, Secondary progressive, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

International audience; Objectives: The long-term impact of interferon-beta-1b (IFN) might be improved by short-term immunosuppression with mitoxantrone (MITOX) in aggressive relapsing-remitting multiple sclerosis (ARMS) patients. Methods: In this 3-year clinical and MRI study, 109 ARMS patients (two or more relapses in the previous 12 months and one or more gadolinium (Gd)-enhancing MRI lesion) were randomised into two groups: 54 patients received MITOX monthly (12 mg/m2; maximum 20 mg) combined with 1 g of methylprednisolone (MP) for 6 months followed by IFN for the last 27 months, and 55 patients received IFN for 3 years combined with 1 g of MP monthly for the first 6 months. The primary endpoint was the time to worsen by at least one Expanded Disability Status Scale point confirmed at 3 months. Results: The time to worsen by at least one Expanded Disability Status Scale point confirmed at 3 months was delayed by 18 months in the MITOX group compared with the IFN group (p

Published
2011

5. Spectrum of short-term inflammatory musculoskeletal manifestations after COVID-19 vaccine administration: a report of 66 cases

Author

Francesca Motta, Veronica Brusi, Corrado Campochiaro, Lorenzo Dagna, Enrico Fusaro, Ilenia Di Cola, Clodoveo Ferri, Fabio Cacciapaglia, Caterina Bruno, Rosario Foti, Riccardo Meliconi, Francesca Francioso, Felice Galluccio, Serena Guiducci, Vincenzo Raimondo, Jacopo Ciaffi, Annamaria Iagnocco, Giovanna Cuomo, Giacomo De Luca, Antonio Tavoni, Francesco Ursini, Roberto Giacomelli, Maria De Santis, Silvia Bilia, Piero Ruscitti, Salvatore D'Angelo, Florenzo Iannone, Domenico Olivo, Martina D'Onghia, Rossella De Angelis, Marcella Visentini, Luana Mancarella, E. Pigatto, Ursini, F., Ruscitti, P., Raimondo, V., De Angelis, R., Cacciapaglia, F., Pigatto, E., Olivo, D., Di Cola, I., Galluccio, F., Francioso, F., Foti, R., Tavoni, A., D'Angelo, S., Campochiaro, C., Motta, F., De Santis, M., Bilia, S., Bruno, C., DE LUCA, Giacomo, Visentini, M., Ciaffi, J., Mancarella, L., Brusi, V., D'Onghia, M., Cuomo, G., Fusaro, E., Dagna, L., Guiducci, S., Meliconi, R., Iannone, F., Iagnocco, A., Giacomelli, R., Ferri, C., Ursini, Francesco, Ruscitti, Piero, Raimondo, Vincenzo, De Angelis, Rossella, Cacciapaglia, Fabio, Pigatto, Erika, Olivo, Domenico, Di Cola, Ilenia, Galluccio, Felice, Francioso, Francesca, Foti, Rosario, Tavoni, Antonio, D'Angelo, Salvatore, Campochiaro, Corrado, Motta, Francesca, De Santis, Maria, Bilia, Silvia, Bruno, Caterina, De Luca, Giacomo, Visentini, Marcella, Ciaffi, Jacopo, Mancarella, Luana, Brusi, Veronica, D'Onghia, Martina, Cuomo, Giovanna, Fusaro, Enrico, Dagna, Lorenzo, Guiducci, Serena, Meliconi, Riccardo, Iannone, Florenzo, Iagnocco, Annamaria, Giacomelli, Roberto, Ferri, Clodoveo, Ursini, F, Ruscitti, P, Raimondo, V, De Angelis, R, Cacciapaglia, F, Pigatto, E, Olivo, D, Di Cola, I, Galluccio, F, Francioso, F, Foti, R, Tavoni, A, D'Angelo, S, Campochiaro, C, Motta, F, De Santis, M, Bilia, S, Bruno, C, De Luca, G, Visentini, M, Ciaffi, J, Mancarella, L, Brusi, V, D'Onghia, M, Cuomo, G, Fusaro, E, Dagna, L, Guiducci, S, Meliconi, R, Iannone, F, Iagnocco, A, Giacomelli, R, and Ferri, C

Subjects
Male, medicine.medical_specialty, COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), Immunology, Population, Arthritis, medicine.disease_cause, General Biochemistry, Genetics and Molecular Biology, polymyalgia rheumatica, Immune system, Rheumatology, Rheumatic Diseases, Pandemic, medicine, Immunology and Allergy, Humans, Musculoskeletal Diseases, Covid-19, arthritis, vaccination, Intensive care medicine, Adverse effect, education, education.field_of_study, business.industry, SARS-CoV-2, COVID-19, Female, Middle Aged, medicine.disease, Vaccination, arthriti, Molecular mimicry, business
Abstract

In the past months, mass vaccination represented the turning point of the global battle against the COVID-19 pandemic, an unprecedented challenge for physicians, healthcare professionals, health systems and pharmaceutical companies. More than 6 billion doses of vaccine have been administered to date, covering nearly 50% of the world’s population. Although the vaccination campaign is still thwarted by spread of fake news disseminated by a ubiquitous antivaxxer movement, accumulating real-life data1 confirm the favourable safety profile already demonstrated in phase III clinical trials.2 Despite the lack of a steady literature evidence,3 the potential role of vaccines in promoting autoimmunity continues to intrigue many researchers. The theoretical basis of this association relies on the possible molecular mimicry between macromolecular components of the vaccine and specific human proteins and the exuberant immune response elicited by adjuvants contained in vaccines.4 Adverse events (AEs) associated with COVID-19 vaccines are usually mild and mainly restricted to injection site reactions. Interestingly, among systemic AEs, arthralgia is one of the most common.2 To the best of our knowledge, only isolated cases5 of arthritis developed after COVID-19 …

Published
2022

6. Fibromyalgia: a new facet of the post-COVID-19 syndrome spectrum? Results from a web-based survey

Author

Micaela La Regina, Pasquale Viola, Riccardo Meliconi, Marco Miceli, Piero Ruscitti, Elena Borlandelli, Nicola Baldini, Lucia Lisi, Annamaria Iagnocco, Luana Mancarella, Jacopo Faranda Cordella, Cesare Faldini, Carlotta Cavallari, Veronica Brusi, Roberto De Giorgio, Claudio Borghi, Anna Mari, Francesco Ursini, Roberto Giacomelli, Martina D'Onghia, Maria Paola Landini, Jacopo Ciaffi, Alessandro Gasbarrini, and Ursini F, Ciaffi J, Mancarella L, Lisi L, Brusi V, Cavallari C, D'Onghia M, Mari A, Borlandelli E, Faranda Cordella J, La Regina M, Viola P, Ruscitti P, Miceli M, De Giorgio R, Baldini N, Borghi C, Gasbarrini A, Iagnocco A, Giacomelli R, Faldini C, Landini MP, Meliconi R

Subjects
Male, medicine.medical_specialty, Fibromyalgia, Coronavirus disease 2019 (COVID-19), Cross-sectional study, Immunology, Affect (psychology), Infections, COVID-19 Testing, Post-Acute COVID-19 Syndrome, Rheumatology, Internal medicine, Surveys and Questionnaires, Immunology and Allergy, Medicine, Humans, COVID-19, fibromyalgia, health services research, Cross-Sectional Studies, Female, Internet, SARS-CoV-2, United States, business.industry, Health services research, medicine.disease, Obesity, Facet (psychology), business
Abstract

ObjectivePostacute COVID-19 syndrome (PACS) is an emerging entity characterised by a large array of manifestations, including musculoskeletal complaints, fatigue and cognitive or sleep disturbances. Since similar symptoms are present also in patients with fibromyalgia (FM), we decided to perform a web-based cross-sectional survey aimed at investigating the prevalence and predictors of FM in patients who recovered from COVID-19.MethodsData were anonymously collected between 5 and 18 April 2021. The collection form consisted of 28 questions gathering demographic information, features and duration of acute COVID-19, comorbid diseases, and other individual’s attributes such as height and weight. The American College of Rheumatology (ACR) Survey Criteria and the Italian version of the Fibromyalgia Impact Questionnaire completed the survey.ResultsA final sample of 616 individuals (77.4% women) filled the form 6±3 months after the COVID-19 diagnosis. Of these, 189 (30.7%) satisfied the ACR survey criteria for FM (56.6% women). A multivariate logistic regression model including demographic and clinical factors showed that male gender (OR: 9.95, 95% CI 6.02 to 16.43, pConclusionOur data suggest that clinical features of FM are common in patients who recovered from COVID-19 and that obesity and male gender affect the risk of developing post-COVID-19 FM.

Published
2021

7. Living with arthritis: a 'training camp' for coping with stressful events? A survey on resilience of arthritis patients following the COVID-19 pandemic

Author

Francesco Ursini, Maria Paola Landini, Clodoveo Ferri, Martina D'Onghia, Veronica Brusi, Elisabetta Quaranta, Luana Mancarella, Jacopo Ciaffi, Amelia Spinella, Antonella Bruni, Dilia Giuggioli, Riccardo Meliconi, Lucia Lisi, Ciaffi J., Brusi V., Lisi L., Mancarella L., D'Onghia M., Quaranta E., Bruni A., Spinella A., Giuggioli D., Landini M.P., Ferri C., Meliconi R., and Ursini F.

Subjects
Male, Coping (psychology), Spondylarthropathie, Inflammatory arthritis, Arthritis, Sex Factor, Anxiety, Arthritis, Rheumatoid, Pandemic, Adaptation, Psychological, education.field_of_study, Depression, Brief Report, General Medicine, Middle Aged, Resilience, Psychological, Italy, Female, medicine.symptom, Coronavirus Infections, Case-Control Studie, Arthriti, Human, Adult, medicine.medical_specialty, Population, Pneumonia, Viral, Betacoronavirus, Sex Factors, Rheumatology, Internal medicine, medicine, Humans, education, Pandemics, Aged, Resilience, Betacoronaviru, business.industry, SARS-CoV-2, Coronavirus Infection, Arthritis, Psoriatic, Case-control study, COVID-19, medicine.disease, Case-Control Studies, Spondylarthropathies, Stress, Psychological, business
Abstract

Resilience is defined as “the capacity of individuals to cope successfully with significant change or adversity”. The challenge posed by the COVID-19 pandemic may potentially represent an overwhelmingly stressful event for patients with chronic diseases. Aim of our study was to investigate the levels of resilience in individuals with inflammatory arthritis living in Emilia Romagna, the third hardest-hit Italian region during the ongoing COVID-19 pandemic. To this purpose, we developed a survey consisting of four different sections assessing demographic characteristics, the 14-item resilience scale (RS14) and questionnaires evaluating depression and anxiety. Consecutive patients with inflammatory arthritis were recruited over a short time frame immediately after the end of national lockdown and compared with control individuals from the general population. One hundred twenty-two patients and 173 controls were included. Levels of resilience, as measured by RS14 score, were significantly higher in patients with inflammatory arthritis (82.6 ± 14.0 vs 79.0 ± 12.8, p = 0.018). After stratification for gender, the difference in RS14 score was maintained in women (p = 0.045), but not in men (p = 0.252). High resilience, defined as having a RS14 score > 90, was significantly more prevalent in patients than in controls (30% vs 16%, p = 0.009). In arthritis patients, no significant differences in RS14 were observed after stratification for specific diagnosis, age, or disease duration and activity. Our findings suggest that patients with inflammatory arthritis may be more resilient than the general population towards unexpected stressful events such as the ongoing COVID-19 pandemic.Key Points• Living with inflammatory arthritis may foster resilience.• After COVID-19, patients with inflammatory arthritis were more resilient than the general population. Electronic supplementary material The online version of this article (10.1007/s10067-020-05411-x) contains supplementary material, which is available to authorized users.

Published
2020
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8. Thyroid autoimmunity and dysfunction in multiple sclerosis patients during long-term treatment with interferon beta or glatiramer acetate: an Italian multicenter study

Author

Paolo Ragonese, Simona Malucchi, Antonio Gallo, Mariangela D'Onghia, Viviana Nociti, Marta Radaelli, Valentina Tomassini, M. Rodegher, Giovanni Frisullo, Vincenzina Lo Re, Damiano Paolicelli, Pietro Annovazzi, Claudio Solaro, Massimiliano Calabrese, Claudio Gasperini, Carla Tortorella, Frisullo G, CM, Tortorella, C, Paolicelli, D, Ragonese, P, Annovazzi, P, Radaelli, M, Malucchi, S, Gallo, A, Tomassini, V, Nociti, V, D'Onghia, M, Lo Re, V, Rodegher, M, Solaro, C, Frisullo, G, Calabrese, M, Paolicelli, D, Gallo, Antonio, Gasperini, C., Frisullo, Giovanni, Calabrese, Massimiliano, Tortorella, Carla, Paolicelli, Damiano, Ragonese, Paolo, Annovazzi, Pietro, Radaelli, Marta, Malucchi, Simona, Tomassini, Valentina, Nociti, Viviana, D'Onghia, Mariangela, Lo Re, Vincenzina, Rodegher, Mariemma, Solaro, Claudio, and Gasperini, Claudio

Subjects
Male, Time Factors, Thyroid Gland, Autoimmunity, Adverse effect, medicine.disease_cause, multiple sclerosis, Gastroenterology, thyroid, Immunosuppressive Agent, Risk Factors, Retrospective Studie, Prevalence, interferon beta, Thyroid, adverse effects, autoimmunity, glatiramer acetate, Middle Aged, Treatment Outcome, medicine.anatomical_structure, Italy, Neurology, multiple sclerosi, Thyroid autoimmunity, Cohort, Female, Settore MED/26 - Neurologia, Thyroid function, Immunosuppressive Agents, Interferon beta-1a, Human, Interferon beta-1b, medicine.drug, Adult, medicine.medical_specialty, Time Factor, Thyroid Disease, Risk Assessment, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, medicine, Humans, Glatiramer acetate, Retrospective Studies, business.industry, Risk Factor, Multiple sclerosis, Glatiramer Acetate, medicine.disease, Thyroid Diseases, Immunology, Neurology (clinical), business
Abstract

Few long-term follow-up data are available on thyroid dysfunction (TD) in multiple sclerosis (MS) patients treated with glatiramer acetate (GA) or with interferon-beta (IFNb). In a cohort of 787 relapsing-remitting MS (RRMS) patients whom were followed up for 8 years, we observed an increased prevalence of TD and thyroid autoimmunity (TA) within the first year of IFNb treatment, regardless of the dose or frequency of administration, while no change was observed with GA treatment. The increased prevalence of TD and TA within the first year of IFNb treatment suggested the need for close monitoring of thyroid function and autoimmunity, though only during the first year of IFNb treatment. © The Author(s) 2014.

Published
2014

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