Golimumab as the First-, Second-, or at Least Third-Line Biologic Agent in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis: Post Hoc Analysis of a Noninterventional Study in Germany

Abstract

Introduction: While golimumab (GLM) has demonstrated efficacy in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in several randomized clinical trials with biologic-naïve patients, observational data from biologic-experienced patients are sparse. We aimed to assess the effectiveness of GLM used as the first-, second-, or at least third-line biologic agent in RA, PsA, and AS patients in a real-world setting. Methods: Post hoc analysis of the noninterventional, prospective, 24-month GO-NICE study of RA, PsA, and AS patients who initiated GLM 50 mg subcutaneously once monthly in a real-world setting in Germany. Results: In 1454 patients with RA, PsA, or AS, GLM was administered as the first-line (n = 305, 286, 292, respectively), second-line (n = 104, 136, 130, respectively), or at least third-line (n = 64, 79, 58, respectively) biologic agent. In RA patients (n = 473), the time since first diagnosis was 9.7, 10.1, and 14.3 years, respectively. The DAS28 score at BL was 5.0, 4.9, and 5.1 in patients using GLM as a first-, second-, and third-line biologic agent, respectively, and dropped significantly in all groups. After 3 months of treatment, 27.5%, 19.5%, and 14.5% of patients were in remission; the corresponding values after 24 months were 45.3%, 50.0%, and 33.3%, respectively. In PsA patients (n = 501), time since fist diagnosis was 12.4, 13.7, and 13.8 years, respectively. Based on PsARC, a response was achieved at 24 months in the first-, second-, and third-line use of GLM in 76.4%, 51.0%, and 50.0% of the patients. In AS patients (n = 480), the time since first diagnosis was 9.4, 9.8, and 12.4 years in patients using GLM as the first-, second-, and at least third-line biologic agent, respectively. After 24 months of treatment, the mean BASDAI scores decreased significantly (p \ 0.001 vs. BL) to 2.1, 2.9, and 2.9 in the patients using GLM as the first-, second-, and at least third-line treatment, respectively. Conclusions: Golimumab is an effective treatment in patients with RA, PsA, and AS,

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

“…This real-life prospective study specifically focused on the effectiveness of GLM in a subgroup of patients who are not normally included in clinical trials, and our findings reveal that in patients with spondyloarthropathies (axSpA and PsA) as well as RA, who need to discontinue their first anti-TNF drug, the decision to switch to GLM can be considered a suitable therapeutic choice. These findings are in agreement with results reported in other recent real-life studies [ 21 , 22 , 23 , 24 , 25 , 26 ].…”

“…The post hoc analysis of the prospective GO-NICE study undertaken in Germany also evaluated the effectiveness of GLM by line of treatment in patients with RA, PsA and AS [ 25 ]. In patients with RA (N = 104) given GLM as a second-line biologic, DAS-28 decreased from 4.9 ± 1.3 to 3.4 ± 1.5 and 19.5% were in remission at 6 months.…”

“…However, in patients with PsA or axSpA, data on the effectiveness of GLM following the first-line anti-TNF failure are scarce [ 19 , 20 ]. To address this gap, recent real-life retrospective studies performed in Spain [ 21 ], Turkey [ 22 ], France [ 23 , 24 ], Germany [ 25 ] and Italy [ 26 ] have examined the long-term effectiveness and retention rate of GLM. The present prospective study, GO-BEYOND, was designed to evaluate the effectiveness of GLM as a second anti-TNF drug in patients with RA, axSpA or PsA who discontinued a first anti-TNF drug.…”

Long-term effectiveness and safety of infliximab and golimumab in ankylosing spondylitis patients from a Canadian prospective observational registry

“…Although there are a substantial number of prospective registries evaluating the effect of anti-TNFs therapy in inflammatory arthritis, the majority of them follow only rheumatoid arthritis patients and collect predominantly safety and/or drug retention data [32]. Indeed, only a few multi-centre registries collect real-world prospective data on anti-TNF agents in AS patients and these include a number of national rheumatology registries from Scandinavian countries [33], GO-NICE from Germany [34,35], ATTRA from the Czech Republic [36], the LORHEN registry in Northern Italy [37], the Korean registry OSKAR [38], the US-based CORRONA registry [39], BIOBADABRASIL [40] and, finally, the DEvenir des Spondylarthropathies Indifférenciées Récentes (DESI R) cohort in France [41]. Among them, BioTRAC is one of the oldest and longest-running AS drug registries.…”

Long-Term Effectiveness and Safety of Infliximab and Golimumab in Ankylosing Spondylitis Patients from a Canadian Prospective Observational Registry

“…Although there are a substantial number of prospective registries evaluating the effect of anti-TNFs therapy in in ammatory arthritis, the majority of them follow only rheumatoid arthritis patients and collect predominantly safety and/or drug retention data (32). Indeed, only a few multi-centre registries collect real-world prospective data on anti-TNF agents in AS patients and these include a number of national rheumatology registries from Scandinavian countries (33), GO-NICE from Germany (34,35), ATTRA from the Czech Republic (36), the LORHEN registry in Northern Italy (37), the Korean registry OSKAR (38), the US-based CORRONA registry (39), BIOBADABRASIL (40) and, nally, the DEvenir des Spondylarthropathies Indifférenciées Récentes (DESIR) cohort in France (41). Among them, BioTRAC is one of the oldest and longest-running AS drug registries.…”