CO:02:2 | Effectiveness of tumor necrosis factor inhibitors in rheumatoid arthritis: real world data from an Italian National Registry

Valerio Fiorilli¹, Francesca Romana Spinelli¹, Florenzo Iannone², Chiara Bazzani³, Alberto Cauli⁴, Rosario Foti⁵, Marcello Govoni⁶, Francesco Paolo Cantatore⁷, Fabiola Atzeni⁸, Roberto Caporali⁹, Marco Sebastiani¹⁰, Roberta Ramonda¹¹, Serena Bugatti¹², Elisa Gremese¹³, Maria Sole Chimenti¹⁴, Bruno Frediani¹⁵, Maurizio Rossini¹⁶, Angelo Semeraro¹⁷, Leonardo Santo¹⁸, Gianfranco Ferraccioli¹⁹, Giovanni Lapadula²⁰, Fabrizio Conti¹. | ¹Dipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari, Sapienza Università di Roma; ²Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica, Università degli Studi Aldo Moro, Bari; ³ASST Spedali Civili di Brescia, Unità di Reumatologia ed Immunologia Clinica, Brescia; ⁴Dipartimento di Scienze Mediche e Sanità Pubblica, Università degli Studi di Cagliari; ⁵A.O.U. Policlinico S. Marco, UOS Reumatologia, Catania; ⁶Dipartimento di Scienze Mediche, Università di Ferrara; ⁷Unità di Reumatologia,  Dipartimento di Medicina Specialistica, Università di Foggia; ⁸Dipartimento di Medicina Interna e Terapia Medica, UOC di Reumatologia, Università di Messina; ⁹Dipartimento di Scienze Cliniche e di Comunità, Università di Milano; ¹⁰Dipartimento di Medicina e Chirurgia, Università di Parma; ¹¹Unità di Reumatologia, Dipartimento di Medicina, Università di Padova; ¹²Dipartimento di Medicina Interna e Terapia Medica, Università di Pavia, ; ¹³IRCCS Istituto Clinico Humanitas, Dipartimento di Scienze Biomediche, Milano; ¹⁴Dipartimento di Medicina dei Sistemi, Università degli Studi di Roma-Tor Vergata, ; ¹⁵Dipartimento di Medicina Clinica e Scienze Immunologiche, Università di Siena; ¹⁶Dipartimento di Medicina, Università di Verona; ¹⁷Presidio Ospedaliero Valle d'Itria, Unità Operativa di Reumatologia, Martina Franca; ¹⁸Presidio Ospedaliero "Mons. Dimiccoli", Unità Operativa Semplice di Reumatologia, Barletta; ¹⁹Gruppo Italiano di Studio sulla Early Arthritis, GISEA, Roma; ²⁰Gruppo Italiano di Studio sulla early Arthritis, GISEA, Bari, Italy.

Tumor necrosis factor inhibitors (TNFi) remain a cornerstone in the management of rheumatoid arthritis (RA), representing the first-line biologic therapy for most patients. This study aimed to assess the real-world effectiveness of TNFi in RA patients. To this purpose, we retrospectively analysed data from RA patients treated with TNFi and enrolled in an Italian national registry. Baseline demographic and clinical characteristics included age, sex, body mass index (BMI), tobacco use, comorbidities, rheumatoid factor and ACPA positivity, line of biologic therapy, VAS pain, patient and physician global assessment, DAS28, CDAI, SDAI, HAQ-DI, use of concomitant glucocorticoids (including dose), and csDMARD co-therapy. Changes in disease activity, quality of life, and steroid use were assessed at 12 months. Remission rates were evaluated at 3, 6, 12, 24, and 60 months. Drug survival was analyzed at 6, 12, 24, and 60 months. Discontinuations and reasons for treatment withdrawal were also recorded. Baseline demographic and clinical characteristics are summarized in Table 1. A significant reduction in disease activity (measured as DAS28, CDAI and SDAI), quality of life and proportion of patients in steroid therapy was observed at 12 months, with DAS28 remission rates of 36% at 3 months, 45%% at 6 months, 44%% at 12 months, 59% at 24 months, and 50% at 60 months. TNFi survival rates were 87.5% at 6 months, 76.8% at 12 months, 63.8% at 24 months, and 44.3% at 60 months. The overall drug survival is depicted in Figure 1A. A significant reduction in treatment survival was observed when TNFi were prescribed at third or further therapeutic line (Figure 1B), while co-therapy with csDMARDs had no influence on survival on treatment (Figure 1C). A total of 942 treatment discontinuations were recorded during follow-up. The main reason for treatment discontinuation was represented by loss of efficacy (30.5% of patients), while adverse events led to suspension in 11.6% of cases. In summary, in this real-world Italian cohort, TNFi therapy was associated with a sustained reduction in disease activity, increasing remission rates over time, and good long-term treatment persistence up to 5 years.