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

Abstract

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-TNFα 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.

Real‐world effectiveness and persistence of golimumab as second‐line anti‐TNFα drug in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis patients in Italy: GO‐BEYOND, a 12‐month prospective observational study

“…Results from the present study confirm findings of earlier studies on the effectiveness and persistence of GLM given as second-line anti-TNF in patients with RA, PsA, and axSpA and extend our previous 6-month results 15…”

“…Results from this 1-year GO-BEYOND study confirm and extend our previous 6-month results. 15 GLM as second-line anti-TNFα for RA, PsA, and axSpA displayed a favorable benefit: risk profile, with approximately 80% of patients maintaining treatment up to 12 months.…”

“…Visits were performed at baseline, 3, 6, and 12 months. The characteristics of patients as well as inclusion and exclusion criteria have been described in detail elsewhere 15 . In this study, the effectiveness and persistence of GLM, in addition to QoL, was evaluated up to 12 months.…”

“…Baseline clinical characteristics have been previously reported 15 and are briefly summarized in Table S1.…”

“…9-14 Previously, we evaluated the effectiveness of GLM as a second anti-TNF drug in patients with RA, axSpA, or PsA up to 6 months. 15 This analysis of the GO-BEYOND study evaluated the effectiveness and retention rate up to 12 months.…”