Favalli, Ennio G. https://orcid.org/0000-0003-1471-6467
Luchetti Gentiloni, Michele M.
Selmi, Carlo
Ramonda, Roberta
Grembiale, Rosa D.
Dagna, Lorenzo
D’Angelo, Salvatore
Gerli, Roberto
Foti, Rosario
Ciccia, Francesco
Guggino, Giuliana
Franceschini, Franco
Chimenti, Maria S.
Rossini, Maurizio
Lubrano, Ennio
Frediani, Bruno
Marelli, Silvia
Zabotti, Alen
Funding for this research was provided by:
Janssen Cilag SpA, a Johnson and Johnson company
Article History
Received: 28 May 2025
Accepted: 9 July 2025
First Online: 25 July 2025
Declarations
:
: Ennio G. Favalli has received consulting fees and/or speaking engagements from AbbVie, Alfa-Sigma, Eli-Lilly, Pfizer, Galapagos, Janssen, Novartis and UCB. Michele M. Luchetti Gentiloni has received research support from AbbVie; consulting fees from AbbVie, Alpha-Wasserman, Johnson and Johnson, Novartis, Pfizer; speaker fees from Alpha-Wasserman, Amgen, Eli-Lilly, Johnson & Johnson, Novartis, Pfizer, UCB. Carlo Selmi has received consulting/speakers fee/research support from AbbVie, Amgen, Alfa-Sigma, Biogen, Eli-Lilly, Johnson and Johnson, Novartis, Octapharma, Pfizer, Recordati Rare Disease, SOBI and UCB. Roberta Ramonda has received consulting fees and/or speaking engagements from AbbVie, Novartis, Eli-Lilly, Johnson and Johnson, UCB and Pfizer. Lorenzo Dagna has received consultation honoraria from Abbvie, Alfa-Sigma, Amgen, AstraZeneca, Biogen, Bristol Myers Squibbs, Eli-Lilly, Galapagos, GSK, Johnson and Johnson, Kiniksa Pharmaceuticals, Novartis, Pfizer, Sanofi-Genzyme, SOBI, UCB and Vifor. Salvatore D’Angelo has received consulting and speaking fees from AbbVie, Amgen, Janssen, Eli-Lilly, MSD Italy, Novartis, Pfizer and UCB. Rosario Foti has received consulting fees and/or speaking engagements from AbbVie, Alfa-Sigma, Eli-Lilly, Pfizer, Galapagos, Janssen, Novartis and UCB. Francesco Ciccia has received consulting fees and/or speaking engagements from AbbVie, Alfa-Sigma, Eli-Lilly, Pfizer, Galapagos, Janssen, Novartis, UCB, AstraZeneca and GSK. Giuliana Guggino has received consulting fees and/or speaking engagements from Abbvie, Johnson and Johnson, Eli-Lilly, Alfa-Sigma, UCB, Novartis, Vifor and GSK. Franco Franceschini has received consulting fees and/or speaking engagements from AbbVie, Janssen, Novartis, GSK, AstraZeneca and UCB. Maria S. Chimenti has received consulting fees and/or speaking engagements from AbbVie, Novartis, Eli-Lilly, Johnson&Johnson, UCB and Pfizer. Maurizio Rossini has received consulting fees and/or speaking engagements from AbbVie, Eli-Lilly, Janssen, Italfarmaco, Neopharmed-Gentili, Theramex and UCB. Ennio Lubrano has received honoraria fees from Abbvie, Eli-Lilly, Janssen and UCB. Silvia Marelli is an employee of Janssen-Cilag SpA—Italy, a Johnson & Johnson company. Alen Zabotti has received consulting fees and/or speaking engagements from AbbVie, Eli-Lilly, Johnson and Johnson, Novartis, UCB and Amgen. Alen Zabotti and Ennio Lubrano are Editorial Board members of Rheumatology and Therapy. Alen Zabotti and Ennio Lubrano were not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. The remaining authors (Rosa D. Grembiale, Roberto Gerli, Bruno Frediani) declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
: The study was approved by the Ethics Committee of all the sites involved in the research: Ethics Committee of ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, Milano (“master” Ethics Committee of the coordinating center); Ethics Committee of Ospedali Riuniti, Ancona; Ethics Committee of Ospedale La Colletta ASL 3 Genovese, Arenzano; Ethics Committee of ASST Spedali Civili, Brescia; Ethics Committee of Ospedale “Antonio Cardarelli”, Campobasso; Ethics Committee of Policlinico San Marco, Catania; Ethics Committee of Policlinico Vittorio Emanuele, Catania; Ethics Committee of A.O.U. Mater Domini Campus Universitario “Salvatore Venuta”, Catanzaro; Ethics Committee of A.O. “Pugliese Ciaccio”, Catanzaro; Ethics Committee of Humanitas Research Hospital, Milano; Ethics Committee of IRCCS Ospedale San Raffaele, Milano; Ethics Committee of Azienda Ospedaliera Universitaria “Federico II”, Napoli; Ethics Committee of AOU Università degli Studi della Campania “Luigi Vanvitelli”, Napoli; Ethics Committee of Azienda ULSS 6 EUGANEA Distretto n. 1 Bacchiglione Poliambulatorio, Padova; Ethics Committee of Azienda Ospedaliera Università di Padova, Padova; Ethics Committee of A.O.U. Policlinico ‘Paolo Giaccone’, Palermo; Ethics Committee of AO Santa Maria della Misericordia, Perugia; Ethics Committee of P.O. Azienda Ospedaliera Regionale San Carlo, Potenza; Ethics Committee of Ospedale Busacca ASP, Ragusa; Ethics Committee of Fondazione PTV Policlinico Tor Vergata, Roma; Ethics Committee of Azienda Ospedaliera Universitaria Senese, Siena; Ethics Committee of Azienda Sanitaria Universitaria Friuli Centrale, Udine; Ethics Committee of Ospedale Policlinico “G.B. Rossi” Borgo Roma, Verona. The study was conducted according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. All patients provided written informed consent to participate in the study. Reporting was conducted following the Sex and Gender Equity in Research (SAGER) guidelines [].