Effectiveness of Golimumab as Second Anti-TNFα Drug in Patients with Rheumatoid Arthritis, Psoriatic Arthritis and Axial Spondyloarthritis in Italy: GO-BEYOND, a Prospective Real-World Observational Study

被引:6
|
作者
D'Angelo, Salvatore [1 ]
Tirri, Enrico [2 ]
Giardino, Angela Maria [3 ]
Mattucci-Cerinic, Marco [4 ,5 ]
Dagna, Lorenzo [5 ]
Santo, Leonardo [6 ]
Ciccia, Francesco [7 ]
Frediani, Bruno [8 ]
Govoni, Marcello [9 ]
Pallavicini, Francesca Bobbio [10 ]
Grembiale, Rosa Daniela [11 ]
Delle Sedie, Andrea [12 ]
Mule, Rita [13 ]
Cantatore, Francesco Paolo [14 ]
Foti, Rosario [15 ]
Gremese, Elisa [16 ]
Conigliaro, Paola [17 ]
Salaffi, Fausto [18 ]
Viapiana, Ombretta [19 ]
Cauli, Alberto [20 ]
Giacomelli, Roberto [21 ]
Arcarese, Luisa [21 ]
Guggino, Giuliana [22 ]
Russo, Romualdo [23 ]
Puenpatom, Amy [24 ]
Capocotta, Domenico [2 ]
Nacci, Francesca [25 ]
Anelli, Maria Grazia [26 ]
Picerno, Valentina [1 ]
Binetti, Corrado [3 ]
Iannone, Florenzo [26 ]
机构
[1] AOR San Carlo Potenza, Dipartimento Reg Reumatol, Ist Reumatol Lucano IReL, I-85100 Potenza, Italy
[2] Osped San Giovanni Bosco, UOSD Reumatol, I-80144 Naples, Italy
[3] Med Affairs MSD Italia Srl, I-00189 Rome, Italy
[4] AO Careggi Univ, I-50134 Florence, Italy
[5] Univ Vita Salute San Raffaele, IRCCS San Raffaele Sci Inst, Unit Immunol Rheumatol Allergy & Rare Dis UnIRAR, I-20132 Milan, Italy
[6] UOS Reumatol ASL BT DSS 4, I-76121 Barletta, Italy
[7] AOU Univ Campania Luigi Vanvitelli, I-80138 Naples, Italy
[8] Azienda Osped Univ Senese, UOC Reumatol, I-53100 Siena, Italy
[9] Univ Ferrara, Dipartimento Sci Med, UOC Reumatol, AOU S Anna Ferrara, I-44121 Ferrara, Italy
[10] Fdn IRCCS Policlin San Matteo SC Reumatol, I-27100 Pavia, Italy
[11] Univ Magna Graecia di Catanzaro, Dipartimento Sci Salute, Rheumatol Res Unit, I-88100 Catanzaro, Italy
[12] UO Reumatol Azienda Osped Univ Pisana, I-56126 Pisa, Italy
[13] IRCCS Azienda Osped Univ Bologna, Policlin St Orsola, UO Reumatol, I-40138 Bologna, Italy
[14] Osped Riuniti Foggia, UOC Reumatol Univ, I-71122 Foggia, Italy
[15] AOU Policlin G Rodolico S Marco, UO Reumatol, I-95123 Catania, Italy
[16] Univ Cattolica Sacro Cuore, Fdn Policlin Univ A Gemelli IRCCS, I-00168 Rome, Italy
[17] Univ Roma Tor Vergata, Dipartimento Med Sistemi, UOC Reumatol, I-00133 Rome, Italy
[18] Univ Politecn Marche, Osped C Urbani, Clin Reumatol, I-60035 Ancona, Italy
[19] Osped Borgo Roma Policlin GB Rossi, UOC Reumatol, I-37126 Verona, Italy
[20] Univ Policlin Monserrato, Azienda Osped, I-09124 Cagliari, Italy
[21] Univ CampusBio Med Roma, UOC ImmunoReumatol, I-00128 Rome, Italy
[22] Univ Palermo, PROMISE Dept, I-90133 Palermo, Italy
[23] AORN, A Cardarelli UOS Reumatol, I-80131 Naples, Italy
[24] Merck & Co Inc, Ctr Observat & Real World Evidence, Kenilworth, NJ 07033 USA
[25] Univ Florence, Div Rheumatol AOUC, Dept Expt & Clin Med, I-50134 Florence, Italy
[26] Univ Bari, Rheumatol Unit, DETO, I-70124 Bari, Italy
关键词
golimumab; anti-TNF inhibitor; biologic; rheumatoid arthritis; psoriatic arthritis; axial spondyloarthritis; DISEASE-ACTIVITY SCORE; QUALITY-OF-LIFE; ANKYLOSING-SPONDYLITIS; CLASSIFICATION CRITERIA; EULAR RECOMMENDATIONS; DOUBLE-BLIND; THERAPY; MANAGEMENT; EFFICACY; SAFETY;
D O I
10.3390/jcm11144178
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
In this prospective observational study, data were collected from 34 rheumatology clinics in Italy in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) who started golimumab (GLM) as a second anti-TNF alpha drug. The primary objective was to evaluate the effectiveness of GLM after 6 months. Changes in quality of life using the EQ-5D-5L were also assessed. A total of 194 patients aged 53.2 +/- 12 years started GLM as a second anti-TNF drug: 39 (20.1%) with RA, 91 (46.9%) with PsA and 64 (32.9%) with axSpA. After 6 months of GLM treatment, 68% of RA patients achieved low disease activity (LDA; DAS28-CRP <= 3.2), 31.9% of PsA patients achieved minimal disease activity and 32.5% of axSpA patients achieved LDA (ASDAS-CRP < 2.1). Good/moderate EULAR response was achieved in 61.9% and 73.8% of patients with RA and PsA, respectively, and 16% of axSpA patients achieved a 50% improvement in BASDAI. Across all indications, improvements in disease activity measures and EQ-5D-5L domains were observed over 6 months. The main reasons for GLM interruption were lack/loss of efficacy (7.2%) or adverse events (2%). This study confirms the effectiveness of GLM as a second-line anti-TNF for the treatment of RA, PsA and axSpA in a real-world setting in Italy.
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页数:16
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