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1. Booster dose of SARS-CoV-2 messenger RNA vaccines strengthens the specific immune response of patients with rheumatoid arthritis: A prospective multicenter longitudinal study

Author

Farroni, Chiara, Aiello, Alessandra, Picchianti-Diamanti, Andrea, Laganà, Bruno, Petruccioli, Elisa, Agrati, Chiara, Garbuglia, Anna Rosa, Meschi, Silvia, Lapa, Daniele, Cuzzi, Gilda, Petrone, Linda, Vanini, Valentina, Salmi, Andrea, Altera, Anna Maria Gerarda, Repele, Federica, Grassi, Germana, Bettini, Aurora, Vita, Serena, Mariano, Andrea, Damiani, Arianna, Infantino, Maria, Grossi, Valentina, Manfredi, Mariangela, Niccoli, Laura, Puro, Vincenzo, Rosa, Roberta Di, Salemi, Simonetta, Sesti, Giorgio, Scolieri, Palma, Bruzzese, Vincenzo, Benucci, Maurizio, Cantini, Fabrizio, Nicastri, Emanuele, and Goletti, Delia

Published
2022
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2. Secukinumab for the Treatment of Axial Spondyloarthritis: Long-Term Real-Life Data from Five Italian Referral Centers.

Author

Gentileschi, Stefano, Cannistrà, Carlo, Gaggiano, Carla, Damiani, Arianna, Carli, Linda, Benucci, Maurizio, Cantini, Fabrizio, Niccoli, Laura, Vitale, Antonio, Baldi, Caterina, Delle Sedie, Andrea, Cantarini, Luca, Mosca, Marta, Frediani, Bruno, and Guiducci, Serena

Abstract

Background: This study aimed to evaluate the effectiveness and drug retention rate of secukinumab (SCK) in axial spondyloarthritis (ax-SpA) within a multicentric real-life cohort. Methods: Data from patients with ax-SpA treated with SCK at five Italian centers were collected retrospectively, excluding those with a diagnosis of Psoriatic Arthritis. Evaluations were conducted at baseline and at 3, 6, 12, 18, and 24 months. Assessments included C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), BASDAI, and ASDAS-CRP. Results: Seventy-one ax-SpA patients (57.7% female, mean age: 53.86 ± 12.67 years) were enrolled. Baseline mean BASDAI was 6.2 ± 1.4 and ASDAS-CRP was 2.9 ± 1.3. Significant improvements in BASDAI and ASDAS-CRP were observed over time, with BASDAI reducing to 3.5 ± 1.9 (p < 0.0001) and ASDAS-CRP to 1.7 ± 0.9 (p < 0.0001) at 24 months. The follow-up duration averaged 20.46 ± 13.46 months. By the end of follow-up, 29.5% of patients discontinued SCK. The two-year retention rate was 72%. Dropout risk was higher in patients with fibromyalgia (HR: 2.896, p = 0.026). No significant retention differences were found based on sex, age, enthesitis, radiographic disease, combination with cDMARDs, SCK dosage, or previous bDMARD exposure. Lower ASDAS-CRP at the study's end was noted in patients without fibromyalgia (1.4 vs. 2.5, p < 0.001). Conclusions: SCK showed rapid and lasting effectiveness for ax-SpA with a favorable retention rate, though fibromyalgia may reduce treatment persistence. [ABSTRACT FROM AUTHOR]

Published
2024
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3. Efficacy and Safety of Filgotinib in Rheumatoid Arthritis Patients Aged over and under 65 Years (ENANTIA-65).

Author

Benucci, Maurizio, Bardelli, Marco, Cazzato, Massimiliano, Bartoli, Francesca, Damiani, Arianna, Li Gobbi, Francesca, Bandinelli, Francesca, Panaccione, Anna, Di Cato, Luca, Niccoli, Laura, Frediani, Bruno, Mosca, Marta, Guiducci, Serena, and Cantini, Fabrizio

Subjects
OLDER patients, AGE differences, MEDIAN (Mathematics), AGE groups, THROMBOEMBOLISM
Abstract

Background: According to recent data, the age of patients could represent an important risk factor for MACE (major cardiovascular events), cancer, and VTE (venous thromboembolism) during treatment with JAK inhibitors in rheumatoid arthritis. We decided to analyze the population involved in the ReLiFiRa study by identifying two groups of patients: 65 years or more and less than 65 years of age, evaluating the efficacy and tolerability of 200 mg of Filgotinib daily. Methods: Of the 120 ReLiFiRa patients, 54 were younger than 65 years old and 66 patients were 65 years old or older. The data of efficacy and tolerability of treatment with FIL 200 mg daily for 6 months were evaluated. Results: After six months of treatment, FIL was effective in both age groups. In both groups, the median values of steroid DAS28, CDAI, ERS, PCR, tender joints, swollen joints, VAS, HAQ, PGA patients, and PGA physicians were reduced with a statistically significant difference comparing these values with the baseline values. The difference in age did not impact the effectiveness of the drug. The lipid profile data also did not demonstrate significant differences between the two age groups; however, the comparison between younger vs. older patients' populations regarding the total cholesterol/HDL ratio and LDL/HDL ratio shows a statistically significant difference: total cholesterol/HDL 3.4 (2.12–3.66) vs. 3.64 (3.36–4.13) p = 0.0004, LDL/HDL 1.9 (0.98–2.25) vs. 2.41 (2.04–2.73) p = 0.0002. There are no differences regarding the atherogenic index (LDL-C/HDL-C) and coronary risk index (TC/HDL-C) compared to baseline. Conclusions: After six months of treatment with FIL, the older population group showed a higher level of LDL and a lower level of HDL compared to younger patients. The atherogenic index and coronary risk index are higher in patients aged ≥ 65 years, but interestingly, there were no differences when comparing the 6-month data to baseline values. This condition highlights the impact of typical risk factors that act independently of treatment with Filgotinib. [ABSTRACT FROM AUTHOR]

Published
2024
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5. ReLiFiRa (Real Life Filgotinib in Rheumatoid Arthritis): Retrospective Study of Efficacy and Safety in Common Clinical Practice

Author

Benucci, Maurizio, primary, Bardelli, Marco, additional, Cazzato, Massimiliano, additional, Laurino, Elenia, additional, Bartoli, Francesca, additional, Damiani, Arianna, additional, Li Gobbi, Francesca, additional, Panaccione, Anna, additional, Di Cato, Luca, additional, Niccoli, Laura, additional, Frediani, Bruno, additional, Mosca, Marta, additional, Guiducci, Serena, additional, and Cantini, Fabrizio, additional

Published
2023
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7. Therapeutic Potential of Ixekizumab in the Treatment of Ankylosing Spondylitis: A Review on the Emerging Clinical Data

Author

Benucci, Maurizio, Damiani, Arianna, Li Gobbi, Francesca, Grossi, Valentina, Infantino, Maria, Manfredi, Mariangela, Niccoli, Laura, and Cantini, Fabrizio

Subjects
ixekizumab, ankylosing spondylitis, randomized control trials, Review
Abstract

Over the last 20 years, the greatly improved knowledges of underlying pathogenic mechanisms of AS, including the role of tumor necrosis factor (TNF), the interleukin 23/Th17 axis, and interleukin-17 (Il-17), constituted the rationale to develop biologics selectively inhibiting these pathways. For more than 10 years, anti-TNF biologics were successfully employed to treat AS, with marked improvement of signs and symptoms in around 60% of the patients. Recent knowledge of the pathophysiology of spondyloarthritis has highlighted the emerging role of the IL-17/IL-23 axis. New therapies with selective biological drugs have emerged in the treatment of this pathology. In this review, we evaluated the effects of ixekizumab, a new anti–IL-17A, that was licensed both by EMA and FDA in August 2019 for the treatment of ankylosing spondylitis. The review highlights the efficacy and safety data of the 3 randomized controlled trials (COAST V-COAST W-COAST X) and those of the extension to 52 weeks of COAST V and COAST W.

Published
2020

12. Therapeutic Potential of Ixekizumab in the Treatment of Ankylosing Spondylitis: A Review on the Emerging Clinical Data

Author

Benucci,Maurizio, Damiani,Arianna, Li Gobbi,Francesca, Grossi,Valentina, Infantino,Maria, Manfredi,Mariangela, Niccoli,Laura, Cantini,Fabrizio, Benucci,Maurizio, Damiani,Arianna, Li Gobbi,Francesca, Grossi,Valentina, Infantino,Maria, Manfredi,Mariangela, Niccoli,Laura, and Cantini,Fabrizio

Abstract

Maurizio Benucci,1 Arianna Damiani,2 Francesca Li Gobbi,1 Valentina Grossi,3 Maria Infantino,3 Mariangela Manfredi,3 Laura Niccoli,4 Fabrizio Cantini4 1Rheumatology Unit, Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, Florence, Italy; 2Rheumatology Unit, University of Florence, Florence, Italy; 3Immunology and Allergology Laboratory Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, Florence, Italy; 4Rheumatology Unit, S. Stefano Hospital, Azienda USL-Toscana Centro, Prato, ItalyCorrespondence: Maurizio BenucciRheumatology Unit, Azienda Sanitaria USL-Toscana Centro, Hospital S. Giovanni di Dio, Via Torregalli 3, Florence 50143, ItalyTel +39-055-6932636Fax +39-055-6932099Email maurizio.benucci@uslcentro.toscana.itAbstract: Over the last 20 years, the greatly improved knowledges of underlying pathogenic mechanisms of AS, including the role of tumor necrosis factor (TNF), the interleukin 23/Th17 axis, and interleukin-17 (Il-17), constituted the rationale to develop biologics selectively inhibiting these pathways. For more than 10 years, anti-TNF biologics were successfully employed to treat AS, with marked improvement of signs and symptoms in around 60% of the patients. Recent knowledge of the pathophysiology of spondyloarthritis has highlighted the emerging role of the IL-17/IL-23 axis. New therapies with selective biological drugs have emerged in the treatment of this pathology. In this review, we evaluated the effects of ixekizumab, a new anti–IL-17A, that was licensed both by EMA and FDA in August 2019 for the treatment of ankylosing spondylitis. The review highlights the efficacy and safety data of the 3 randomized controlled trials (COAST V-COAST W-COAST X) and those of the extension to 52 weeks of COAST V and COAST W.Keywords: ixekizumab, ankylosing spondylitis, randomized control trials

Published
2020

13. JAK inhibition reduces SARS-CoV-2 liver infectivity and modulates inflammatory responses to reduce morbidity and mortality

Author

Stebbing, Justin, primary, Sánchez Nievas, Ginés, additional, Falcone, Marco, additional, Youhanna, Sonia, additional, Richardson, Peter, additional, Ottaviani, Silvia, additional, Shen, Joanne X., additional, Sommerauer, Christian, additional, Tiseo, Giusy, additional, Ghiadoni, Lorenzo, additional, Virdis, Agostino, additional, Monzani, Fabio, additional, Rizos, Luis Romero, additional, Forfori, Francesco, additional, Avendaño Céspedes, Almudena, additional, De Marco, Salvatore, additional, Carrozzi, Laura, additional, Lena, Fabio, additional, Sánchez-Jurado, Pedro Manuel, additional, Lacerenza, Leonardo Gianluca, additional, Cesira, Nencioni, additional, Caldevilla Bernardo, David, additional, Perrella, Antonio, additional, Niccoli, Laura, additional, Méndez, Lourdes Sáez, additional, Matarrese, Daniela, additional, Goletti, Delia, additional, Tan, Yee-Joo, additional, Monteil, Vanessa, additional, Dranitsaris, George, additional, Cantini, Fabrizio, additional, Farcomeni, Alessio, additional, Dutta, Shuchismita, additional, Burley, Stephen K., additional, Zhang, Haibo, additional, Pistello, Mauro, additional, Li, William, additional, Romero, Marta Mas, additional, Andrés Pretel, Fernando, additional, Simón-Talero, Rafaela Sánchez, additional, García-Molina, Rafael, additional, Kutter, Claudia, additional, Felce, James H., additional, Nizami, Zehra F., additional, Miklosi, Andras G., additional, Penninger, Josef M., additional, Menichetti, Francesco, additional, Mirazimi, Ali, additional, Abizanda, Pedro, additional, and Lauschke, Volker M., additional

Published
2021
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16. Beneficial impact of Baricitinib in COVID-19 moderate pneumonia; multicentre study

Author

Cantini, Fabrizio, primary, Niccoli, Laura, additional, Nannini, Carlotta, additional, Matarrese, Daniela, additional, Natale, Massimo Edoardo Di, additional, Lotti, Pamela, additional, Aquilini, Donatella, additional, Landini, Giancarlo, additional, Cimolato, Barbara, additional, Pietro, Massimo Antonio Di, additional, Trezzi, Michele, additional, Stobbione, Paolo, additional, Frausini, Gabriele, additional, Navarra, Assunta, additional, Nicastri, Emanuele, additional, Sotgiu, Giovanni, additional, and Goletti, Delia, additional

Published
2020
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20. Effectiveness of Adalimumab for the Treatment of Psoriatic Arthritis: An Italian Real-Life Retrospective Study

Author

D'Angelo, Salvatore, primary, Cantini, Fabrizio, additional, Ramonda, Roberta, additional, Cantarini, Luca, additional, Carletto, Antonio, additional, Chimenti, Maria Sole, additional, Delle Sedie, Andrea, additional, Foti, Rosario, additional, Gerli, Roberto, additional, Lomater, Claudia, additional, Lubrano, Ennio, additional, Marchesoni, Antonio, additional, Zabotti, Alen, additional, Salvarani, Carlo, additional, Scrivo, Rossana, additional, Scarpa, Raffaele, additional, Tramontano, Giuseppina, additional, Nannini, Carlotta, additional, Lorenzin, Mariagrazia, additional, Fabbroni, Marta, additional, Martinis, Federica, additional, Perricone, Roberto, additional, Carli, Linda, additional, Visalli, Elisa, additional, Rovera, Guido, additional, Perrotta, Fabio Massimo, additional, Quartuccio, Luca, additional, Altobelli, Alessio, additional, Costa, Luisa, additional, Niccoli, Laura, additional, Ortolan, Augusta, additional, and Caso, Francesco, additional

Published
2019
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30. Tailored first-line biologic and targeted synthetic disease modifying anti-rheumatic drugs therapy in patients with rheumatoid arthritis: 2021 updated ITABIO statements

Author

Cantini, Fabrizio, Goletti, Delia, Benucci, Maurizio, Foti, Rosario, Damiani, Arianna, and Niccoli, Laura

Abstract

ABSTRACTIntroductionIn 2015, the Italian board for the TAilored BIOlogic therapy (ITABIO) proposed evidence-based decisional statements for first-line tailored biologic therapy in patients with rheumatoid arthritis (RA). Taking into account the new licensed drugs, the aim of the present review was to update the previous statements.Areas coveredA narrative review of the most recent evidence on the efficacy and safety of old and newly licensed drugs for the treatment of articular and extra-articular RA was performed. In addition, host-related variables potentially driving the therapy choice, such as the infection risk, the cardiovascular risk, the risk of deep vein thrombosis, thromboembolism, pregnancy, and obesity were analyzed. Consequently, several statements for personalized therapy were formulated, thus providing a decisional algorithm useful for proper personalized therapy of RA patients in clinical practice.Expert opinionSeveral clinical variables related to specific drug and host characteristics may drive the choice toward anti-TNF and non-anti-TNF biologics, or anti-JAKs, thus allowing to personalize the therapy. Consequently, the right therapy for the right patient would ensure a successful therapeutic intervention.

Published
2022
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34. Personalization of biologic therapy in patients with rheumatoid arthritis: less frequently accounted choice-driving variables

Author

Niccoli,Laura, Nannini,Carlotta, Blandizzi,Corrado, Mantarro,Stefania, Mosca,Marta, Di Munno,Ombretta, Goletti,Delia, Benucci,Maurizio, Li Gobbi,Francesca, Cassarà ,Emanuele, Kaloudi,Olga, and Cantini,Fabrizio

Subjects
Therapeutics and Clinical Risk Management
Abstract

Laura Niccoli,1 Carlotta Nannini,1 Corrado Blandizzi,2 Stefania Mantarro,2 Marta Mosca,3 OmbrettaDi Munno,3 Delia Goletti,4 Maurizio Benucci,5 FrancescaLi Gobbi,5 Emanuele Cassarà,1 Olga Kaloudi,1 Fabrizio Cantini1 1Department of Rheumatology, Hospital of Prato, Prato, Italy; 2Section of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy; 3Division of Rheumatology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy; 4Translational Research Unit, Department of Epidemiology and Preclinical Research, National Institute for Infectious Diseases, Rome, Italy; 5Rheumatology Unit, Hospital S. Giovanni di Dio, Florence, Italy Objective: To propose appropriate statements that drive the choice of biologic therapies in patients with rheumatoid arthritis (RA), factoring in their impact on the following issues: anti-drug antibody (ADAb) formation, suspicion and management of infections, lupus-like syndrome (LLS), effects on bone mass and sexual sphere, and relationship between RA and periodontal disease (PD). Methods: An overview of existing evidence was undertaken by an expert panel on behalf of the Italian board for the TAilored BIOlogic therapy (ITABIO). Data were extracted from controlled trials, national registries, national health care databases, post-marketing surveys, and, when required by the paucity of controlled studies, from open-label clinical series. Anti-tumor necrosis factor (anti-TNF) and non-anti-TNF-targeted biologics approved for RA were investigated. Results: ADAb formation is chiefly associated with anti-TNFs, and it is reduced by combination therapy with methotrexate. To date, ADAb titration is not advisable for clinical practice, and, in case of anti-TNF secondary failure, a non-anti-TNF biologic is indicated. LLS is observed in anti-TNF receivers and, in most cases, resolves without anti-TNF withdrawal. A non-anti-TNF biologic is advisable in patients experiencing LLS. Non-anti-TNFs demonstrated a low or absent infection risk and are preferable in patients with comorbidities. Due to their positive effects on bone mass, anti-TNFs are indicated in women at osteoporosis risk, whereas non-anti-TNF have been poorly investigated. The emerging evidence of the relationship between RA and PD and the effects on anti-TNF efficacy should lead clinicians to consider the periodontal status in RA patients. Anti-TNFs may exert a positive effect on fertility and sexuality, and clinicians should explore these aspects in RA patients. Conclusion: The optimization of biologic therapies by taking into proper account the above issues would improve patient outcomes. Keywords: biologics, immunogenicity, infections, lupus-like syndrome, osteoporosis, periodontal disease, sexuality

Published
2018

42. Risk of Tuberculosis Reactivation in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Receiving Non-Anti-TNF-Targeted Biologics

Author

Cantini, Fabrizio, Nannini, Carlotta, Niccoli, Laura, Petrone, Linda, Ippolito, Giuseppe, and Goletti, Delia

Subjects
Article Subject
Abstract

Tuberculosis (TB) still represents an important issue for public health in underdeveloped countries, but the use of antitumor necrosis factor agents (anti-TNF) for the treatment of inflammatory rheumatic disorders has reopened the problem also in countries with low TB incidence, due to the increased risk of TB reactivation in subjects with latent tuberculosis infection (LTBI). Over the last 5 years, several non-anti-TNF-targeted biologics have been licensed for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. We reviewed the epidemiology of TB, the role of different cytokines and of the immune system cells involved in the immune response against TB infection, the methods to detect LTBI, and the risk of TB reactivation in patients exposed to non-anti-TNF-targeted biologics. Given the limited role exerted by the cytokines different from TNF, as expected, data from controlled trials, national registries of biologics, and postmarketing surveillance show that the risk of TB reactivation in patients receiving non-anti-TNF-targeted biologics is negligible, hence raising the question whether the screening procedures for LTBI would be necessary.

Published
2017
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46. Second-line biologic therapy optimization in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

Author

Cantini, Fabrizio, primary, Niccoli, Laura, additional, Nannini, Carlotta, additional, Cassarà, Emanuele, additional, Kaloudi, Olga, additional, Giulio Favalli, Ennio, additional, Becciolini, Andrea, additional, Benucci, Maurizio, additional, Gobbi, Francesca Li, additional, Guiducci, Serena, additional, Foti, Rosario, additional, Mosca, Marta, additional, and Goletti, Delia, additional

Published
2017
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49. Tailored first-line biologic therapy in patients with rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis

Author

Cantini, Fabrizio, primary, Niccoli, Laura, additional, Nannini, Carlotta, additional, Cassarà, Emanuele, additional, Kaloudi, Olga, additional, Giulio Favalli, Ennio, additional, Becciolini, Andrea, additional, Biggioggero, Martina, additional, Benucci, Maurizio, additional, Li Gobbi, Francesca, additional, Grossi, Valentina, additional, Infantino, Maria, additional, Meacci, Francesca, additional, Manfredi, Mariangela, additional, Guiducci, Serena, additional, Bellando-Randone, Silvia, additional, Matucci-Cerinic, Marco, additional, Foti, Rosario, additional, Di Gangi, Marcella, additional, Mosca, Marta, additional, Tani, Chiara, additional, Palmieri, Fabrizio, additional, and Goletti, Delia, additional

Published
2016
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