Florenzo Iannone1, Ennio G Favalli2, Roberto Caporali3, Salvatore D'Angelo4, Francesco Paolo Cantatore5, Piercarlo Sarzi-Puttini6, Rosario Foti7, Fabrizio Conti8, Antonio Carletto9, Elisa Gremese10, Alberto Cauli11, Roberta Ramonda12, Adalgisa Palermo13, Oscar Epis14, Marta Priora15, Francesca Bergossi16, Bruno Frediani17, Fausto Salaffi18, Giuseppe Lopalco19, Fabio Cacciapaglia19, Antonio Marchesoni2, Martina Biggioggiero2, Serena Bugatti3, Silvia Balduzzi3, Antonio Carriero4, Addolorata Corrado5, Sara Bongiovanni6, Alessia Benenati7, Francesca Miranda8, Elena Fracassi20, Daniela Perra11, Gianfranco Ferraccioli10, Giovanni Lapadula19. 1. DETO, Rheumatology Unit, University of Bari, Policlinico, Piazza G. Cesare 11, 70124 Bari, Italy. Electronic address: florenzo.iannone@uniba.it. 2. Dpt of Rheumatology, G Pini Institute, Milan, Italy. 3. Division of Rheumatology, IRCCS Policlinico S. Matteo Foundation, Pavia Dpt of Clincal sciences and Community Health, University of Milan, Milan, Italy. 4. Rheumatology Department of Lucania - AOR San Carlo Hospital of Potenza, Potenza, Italy. 5. Rheumatology UOC Reumatologia, University of Foggia, Foggia, Italy. 6. Rheumatology Unit, ASST Fatebenefratelli-Sacco, Milan, Italy. 7. U.O. Reumatologia A.O.U. Policlinico V.E. Catania, Catania, Italy. 8. Dpt. Scienze Cliniche, Internistiche, Anestesiologiche e Cardiovascolari, Sapienza Università di Roma, Rome, Italy. 9. Rheumatology, UOC Reumatologia, AOUI Verona, Verona, Italy. Electronic address: antonio.carletto@aovr.veneto.it. 10. Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy. 11. Rheumatology Unit, AOU and University of Cagliari, 09042 Monserrato, Cagliari, Italy. 12. Rheumatology Unit, Department of Medicine-DIMED, University Hospital of Padova, Padova, Italy. 13. CHIMOMO, Università di Modena e Reggio Emilia, Modena, Italy. 14. ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy. 15. Rheumatology Unit, AOU Città della Salute e della Scienza, Turin, Italy. 16. UOC Reumatologia - AOU S. Anna Ferrara e Università di Ferrara, Ferrara, Italy. 17. Department of Medical Sciences, Surgery e Neurosciencies, University of Siena, Siena, Italy. 18. Rheumatology Unit, Marche Polytechnic University, Jesi, Italy. 19. DETO, Rheumatology Unit, University of Bari, Policlinico, Piazza G. Cesare 11, 70124 Bari, Italy. 20. Rheumatology, UOC Reumatologia, AOUI Verona, Verona, Italy.
Abstract
OBJECTIVE: To evaluate the clinical effectiveness of golimumab in biologic inadequate responder (IR) patients with Rheumatoid arthritis (RA), Spondyloarthritis (SpA), and Psoriatic arthritis (PsA). METHODS: We analyzed 1424 patients on golimumab from the GISEA registry. Drug survival was estimated by Kaplan-Meier analysis in biologic-naïve, 1-biologic IR, ≥2-biologics IR patients. Hazard ratios (HRs) of discontinuing golimumab at 2 years were assessed by multivariate Cox regression. Patients achieving CDAI based low disease activity (LDA) or BASDAI<4 were calculated at 6 and 12 months. RESULTS: In RA (n.370), the 2-years survival on golimumab was 61.4% in 1-biologic IR, 51.9% in≥2-biologics IR, and 73.1% in biologic-naive patients (P=0.002 vs≥2-biologics IR). In SpA (n.502), the survival was similar among 1-biologic IR (80%), ≥2-biologics IR (76.5%), and biologic-naive (74.6%) patients (P>0.05). In PsA (n.552) the survival was 72% in 1-biologic IR, 72.5% in≥2-biologics IR, and 71.8% in naïve-biologic (P>0.05). Predictors of golimumab discontinuation were monotherapy (HR 1.65) for RA, female gender for SpA (HR 2.48) and PsA (HR 1.57). In RA, patients on CDAI-LDA were lower in 1-biologic IR (40%) or≥2 biologics IR (40%) than in biologic-naïve (60%) group at 6 months (P=0.02), but no difference was observed at 12 months. In PsA and SpA, the percentage of patients on CDAI-LDA or BASDAI<4 at 6 months was almost identical across the subgroups. CONCLUSIONS: Golimumab had similar effectiveness in biologic-failure and biologic-naïve SpA and PsA, but seems to be less effective in multi-failure RA patients, especially as monotherapy. The best outcomes were seen in male patients.
OBJECTIVE: To evaluate the clinical effectiveness of golimumab in biologic inadequate responder (IR) patients with Rheumatoid arthritis (RA), Spondyloarthritis (SpA), and Psoriatic arthritis (PsA). METHODS: We analyzed 1424 patients on golimumab from the GISEA registry. Drug survival was estimated by Kaplan-Meier analysis in biologic-naïve, 1-biologic IR, ≥2-biologics IR patients. Hazard ratios (HRs) of discontinuing golimumab at 2 years were assessed by multivariate Cox regression. Patients achieving CDAI based low disease activity (LDA) or BASDAI<4 were calculated at 6 and 12 months. RESULTS: In RA (n.370), the 2-years survival on golimumab was 61.4% in 1-biologic IR, 51.9% in≥2-biologics IR, and 73.1% in biologic-naive patients (P=0.002 vs≥2-biologics IR). In SpA (n.502), the survival was similar among 1-biologic IR (80%), ≥2-biologics IR (76.5%), and biologic-naive (74.6%) patients (P>0.05). In PsA (n.552) the survival was 72% in 1-biologic IR, 72.5% in≥2-biologics IR, and 71.8% in naïve-biologic (P>0.05). Predictors of golimumab discontinuation were monotherapy (HR 1.65) for RA, female gender for SpA (HR 2.48) and PsA (HR 1.57). In RA, patients on CDAI-LDA were lower in 1-biologic IR (40%) or≥2 biologics IR (40%) than in biologic-naïve (60%) group at 6 months (P=0.02), but no difference was observed at 12 months. In PsA and SpA, the percentage of patients on CDAI-LDA or BASDAI<4 at 6 months was almost identical across the subgroups. CONCLUSIONS:Golimumab had similar effectiveness in biologic-failure and biologic-naïve SpA and PsA, but seems to be less effective in multi-failure RApatients, especially as monotherapy. The best outcomes were seen in male patients.
Authors: Maria Sole Chimenti; Paola Conigliaro; Francesco Caso; Luisa Costa; Augusta Ortolan; Paola Triggianese; Marco Tasso; Giulia Lavinia Fonti; Maria Grazia Lorenzin; Roberto Perricone; Roberta Ramonda Journal: Clin Rheumatol Date: 2021-08-19 Impact factor: 3.650