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RESEARCH PRODUCT

AB0467 EFFECTIVENESS OF GOLIMUMAB AFTER TNF-INHIBITOR FAILURE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, OR AXIAL SPONDYLOARTHRITIS: RESULTS AT 3 MONTHS FROM THE GO-BEYOND ITALY STUDY

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Background:Golimumab showed trial efficacy in subjects with active rheumatoid arthritis (RA) previously treated with TNF-inhibitors (TNFi); no trial data are available for psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).Objectives:To assess the effectiveness of golimumab after TNFi failure in patients with RA, PsA, or axSpA in a real-world setting.Methods:GO-BEYOND-Italy is an ongoing, multicenter, prospective, observational study of RA, PsA, or axSpA patients starting golimumab after TNFi failure. Patients were enrolled between July 2017 and December 2019, and followed for 1 year, with evaluations at 3, 6, and 12 months. This interim analysis estimates the effectiveness after 3 months of golimumab therapy. Differences from baseline were tested by paired t-tests.Results:193 patients were enrolled: 38 (19.7%) with RA (median age 54 years; median disease duration 9.5 years), 91 (47.2%) with PsA (median age 53 years; median disease duration 9.0 years) and 64 (33.2%) with axSpA (median age 54 years; median disease duration 7.2 years). Majority of the RA (73.7%), PsA (51.6%) and axSpA (53.1%) were females. Previous TNFi treatment included etanercept (44.6% of patients), adalimumab (42.0%), infliximab (8.8%) and certolizumab (4.7%). The main reason for switching to golimumab was loss of efficacy of TNFi (78.9% in RA, 83.5% in PsA, 75% in axSpA). Comorbidities were highly prevalent (RA 65.8%, PsA 65.9%, axSpA 75%); hypertension (31.1%), dyslipidaemia (13.5%), fibromyalgia (10.4%) were the most common ones. DAS28-CRP significantly reduced in RA and PsA (p<0.01) after 3 months of treatment. In RA, rates of DAS28-CRP remission and low disease activity (LDA) were 29.6% and 22.2%, respectively, and 65.2% of patients achieved good/moderate EULAR response. As for PsA, good/moderate EULAR response was observed in 78.8% of patients and 28% of patients achieved minimal disease activity. In axSpA, ASDAS-CRP (p<0.01), BASDAI (p<0.01) and ASAS-HI (p=0.032) significantly reduced; rates of ASDAS-CRP inactive disease and LDA were 15.2% and 26.1%, respectively; 14% of patients had a ≥50% improvement in baseline BASDAI. After 3 months of golimumab treatment, there was a decrease in the prevalence of enthesitis (32.9% to 16.5%), nail (17.6% to 12.9%) and skin psoriasis (42.4% to 34.1%) in PsA patients; the frequency of extra articular manifestations tended to decrease also in axSpA patients.Conclusion:Preliminary results of the GO-BEYOND-Italy study showed a good short-term effectiveness of golimumab in RA, PsA and axSpA after TNFi failure.Table 1.Effectiveness of golimumab at 3 months in the GO-BEYOND-Italy studyRheumatoid arthritis (n=38)Psoriatic arthritis (n=91)Axial spondyloarthritis (n=64)DAS28-CRP, mean (SD)n=27DAS28-CRP, mean (SD)n=47ASDAS-CRP, mean (SD)n=44V0 / V14.05 (0.8) / 3.10* (1.0)V0 / V13.66 (1.0) / 2.79* (1.2)V0 / V12.86 (1.0) / 2.33* (1.0)V1: DAS28-CRP disease activity, n (%)n=27V1: EULAR response, n (%)n=33V1: ASDAS-CRP disease activity, n (%)n=46Remission8 (29.6)Good16 (48.5)Inactive disease7 (15.2)Low disease activity6 (22.2)Moderate10 (30.3)Low disease activity12 (26.1)Moderate disease activity13 (48.1)No response7 (21.2)High disease activity22 (47.8)Very high disease activity5 (10.9)V1: EULAR response, n (%)n=23V1: MDA, n (%)n=75Good7 (30.4)Yes21 (28.0)BASDAI, mean (SD)n=50Moderate8 (34.8)V0 / V15.99 (2.1) / 4.92 (2.3)*No response8 (34.8)V1: BASDAI50, n (%)7 (14.0)ASAS-HI, mean (SD)n=48V0 / V110.67 (3.8) / 9.68 (4.6)^*p value for the difference from V0 <0.01. ^ p for the difference from V0=0.032Abbreviations: ASDAS: Ankylosing Spondylitis Disease Activity Score; ASAS-HI: Assessment of SpondyloArthritis international society Health Index; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; CRP: C-reactive protein; DAS: disease activity score; EULAR: European League Against Rheumatism; MDA: Minimal Disease Activity; SD: standard deviation; V0: baseline; V1: 3 months evaluation.Disclosure of Interests:Salvatore D’Angelo Speakers bureau: AbbVie, BMS, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB, Consultant of: AbbVie, BMS, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB, Enrico Tirri Speakers bureau: AbbVie, Eli Lilly, Novartis, Pfizer, Angela Maria Giardino Employee of: MSD Italia, Marco Matucci-Cerinic Speakers bureau: BMS, Pfizer, Actelion, Consultant of: Eli-Lilly, Celgene, Chemomab, CSL Behring, Grant/research support from: BMS, Pfizer, Celgene, CSL Behring, Lorenzo Dagna Consultant of: Abbvie, Amgen, Biogen, Bristol-Myers Squibb, Celltrion, Novartis, Pfizer, Roche, Sanofi-Genzyme, and SOBI, Leonardo Santo: None declared., francesco ciccia: None declared., Bruno Frediani: None declared., Marcello Govoni: None declared., Francesca Bobbio Pallavicini: None declared., Rosa Daniela Grembiale: None declared., Andrea Delle Sedie: None declared., Stefania Cercone Employee of: MSD Italia, RITA MULE’: None declared., Francesco Paolo Cantatore Speakers bureau: Pfizer, Sanofi Genzyme and Roche, Consultant of: Pfizer, Sanofi Genzyme and Roche outside this work., Rosario Foti: None declared., Elisa Gremese: None declared., Roberto Perricone: None declared., Fausto Salaffi: None declared., Ombretta Viapiana Speakers bureau: Novartis, UCB, Abbvie, MSD, Fresenius kabi, Gilead, Biogen, Consultant of: Novartis, Abbvie, Fresenius kabi, Gilead, Biogen, Alberto Cauli Speakers bureau: Abbvie, Alfa-Sigma, BMS, Celgene, Galapagos, Glaxo, MSD, Novartis, Janssen, Pfizer, Sanofi, UCB, Consultant of: Abbvie, Alfa-Sigma, BMS, Celgene, Galapagos, Glaxo, MSD, Novartis, Janssen, Pfizer, Sanofi, UCB, Rorberto Giacomelli: None declared., Luisa Arcarese: None declared., Giuliana Guggino Speakers bureau: Novartis, Celgene, Abbvie, Sandoz, Eli Lilly, Pfizer, Jansen, ROMUALDO RUSSO: None declared., Domenico Capocotta: None declared., Francesca Nacci: None declared., Maria Grazia Anelli: None declared., valentina picerno: None declared., Florenzo Iannone Speakers bureau: Pfizer, AbbVie, Janssen, Celgene, Novartis, MSD, BMS, UCB, Roche, Consultant of: Pfizer, AbbVie, Janssen, Celgene, Novartis, MSD, BMS, UCB, Roche outside this work.