PO:07:099 | Survival on therapy of certolizumab pegol in rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis: 8-year data from an Italian multicenter register

Maria Manara¹, Gilberto Cincinelli^1|2, Marco Fornaro³, Simone Perniola⁴, Elisa Gremese⁵, Chiara Bazzani⁶, Serena Bugatti⁷, Francesca Romana Spinelli⁸, Rosario Foti⁹, Marco Sebastiani¹⁰, Alberto Cauli¹¹, Fabiola Atzeni¹², Giovanni Lapadula¹³, Gianfranco Ferraccioli¹⁴, Fabrizio Conti⁸, Florenzo Iannone³, Roberto Caporali^1|2 | ¹Department of Rheumatology and Medical Sciences, ASST G. Pini-CTO Milano; ²Department of Clinical Sciences and Community Health, University of Milan; ³Department of Precision and Regenerative Medicine and Ionian Area, University of Bari; ⁴Clinical Immunology Division, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma; ⁵Rheumatology and Clinical Immunology, IRCCS Humanitas Research Hospital, Rozzano (MI); ⁶Unit of Rheumatology and Clinical Immunology, ASST Spedali Civili Brescia; ⁷Department of Internal Medicine and Therapeutics, Università di Pavia; ⁸Rheumatology Unit, Dipartimento Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari, Sapienza University, Roma; ⁹Rheumatology Unit, San Marco Hospital, Policlinico University of Catania; ¹⁰Rheumatology Unit, AUSL Piacenza, University of Parma; ¹¹UOC di Reumatologia, Dipartimento di Scienze Mediche e Sanità Pubblica, Azienda Ospedaliero-Universitaria di Cagliari; ¹²Rheumatology Unit, Department of Experimental and Internal Medicine, University of Messina; ¹³Gruppo Italiano di Studio sulla Early Arthritis, GISEA, Bari; ¹⁴Department of Medicine, Università Cattolica del Sacro Cuore, Fondazione IRCCS Policlinico Gemelli, Roma, Italy

Background. To evaluate the persistence in therapy of certolizumab pegol in a multicenter Italian registry of patients affected by rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial and peripheral spondyloarthritis (SpA).

Materials and Methods. Data were collected prospectively from a multicenter Italian registry of patients with RA, PsA, and SpA treated with certolizumab pegol through March 2025. Persistence in therapy was calculated using the Kaplan-Meier method for the three diagnoses. Comparative subanalyses of retention rate were performed using Cox regression across the different populations, by treatment line, sex, concomitant csDMARD, and rheumatoid factor positivity.

Results. A total of 1167 patients were included in the analysis. Of these, 401 were affected by RA (87.8% female, mean age [± standard deviation (SD)] 50.5 [±14.6] years, mean disease duration 10.5 [±9.3] years, 50.4% in first-line biologic, 54.9% in combination with csDMARDs), 448 by PsA (73% female, mean age [±SD] 48.5 [±14] years, mean disease duration 7.6 [±6.7] years, 38.4% in first-line biologic, 65% in combination with csDMARDs) and 318 by SpA (76.4% female, mean age 47.7 [±13.7] years, mean disease duration 7 [±7.4] years, 44.3% in first-line biologic). The retention rate in the RA, PsA, and SpA groups was 78.2%, 74.2%, and 75.5% at 12 months, 63.3%, 56.6%, and 60.4% at 24 months, and 52.7%, 48.5%, and 53.5% at 36 months, respectively. At 8 years, the retention rate was 33.8%, 27.6%, and 35.6% in RA, PsA, and SpA, with no significant difference between the three diagnoses (Figure). Among patients who discontinued the drug in the RA, PsA, and SpA groups, 19.2%, 27%, and 20.1% discontinued due to inefficacy, and 3%, 6.7%, and 6.6% due to adverse events, respectively. In subanalyses stratified by treatment line, first-line survival in RA was not different from second-line survival, but significantly superior to subsequent lines; conversely, in PsA and SpA the retention rate in the first line was statistically higher than in the other treatment lines. In the three indications, survival on therapy was not significantly different between the two sexes. In subjects with RA, survival was longer with biological monotherapy compared to the combination with csDMARDs, while no significant difference was found in PsA and SpA. In RA, rheumatoid factor positivity or negativity was not associated with different retention rates.

Conclusions. In our registry data on certolizumab pegol, we observed a high treatment persistence at 3 years in all indications, and in approximately one third of patients at 8 years, supporting the real-life efficacy and safety of this treatment in RA, PsA and SpA.