Golimumab improves patient-reported outcomes in daily practice of inflammatory rheumatic diseases in Germany

Krueger, Klaus; Remstedt, Sven; Thiele, Astrid; Hohenberger, S

doi:10.2217/cer-2020-0092

Cited by 8 publications

(5 citation statements)

References 21 publications

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“…Compared with previous real-world evidence on golimumab from the non- interventional GO-ART study in Germany, the present study demonstrated more pronounced improvements in TWPI and activity impairment in RA, axSpA and PsA patients ( 19 ). Our study also demonstrated higher improvements in QoL at month 3 and 24 than the GO-ART study ( 19 ). These differences may be the result of a higher proportion of biologic naive patients in this study compared to the GO-ART study (77.3 vs. 67.5%).…”

Section: Discussioncontrasting

confidence: 87%

“…Although these data are in line with other reports indicating that 33.3 to 54.0% of RA patients in Germany are unemployed for any reason ( 18 , 19 ), such a high proportion of unemployed patients could limit the power to detect the impact of golimumab on absenteeism in our study.…”

Section: Discussionsupporting

confidence: 81%

“…The efficacy and safety of golimumab was demonstrated in several large scale randomized controlled clinical trials ( 13 – 15 ) and non-interventional studies ( 16 – 18 ). Furthermore, currently available real-world evidence showed that golimumab improves QoL and work productivity ( 17 , 19 ).…”

Section: Introductionmentioning

confidence: 99%

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A Prospective Study to Evaluate the Impact of Golimumab Therapy on Work Productivity and Activity, and Quality of Life in Patients With Rheumatoid Arthritis, Psoriasis Arthritis and Axial Spondyloarthritis in a Real Life Setting in AUSTRIA. The GO-ACTIVE Study

Dejaco

Mueller

Zamani³

et al. 2022

Front. Med.

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ObjectiveTo analyze real-world evidence on work productivity and daily activity impairment (WPAI) and health-related quality of life (HRQoL) in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) patients treated with golimumab in Austria.MethodsThis was a prospective, non-interventional, multi-center study conducted in RA, PsA and axSpA patients initiating golimumab between April 2016 and May 2020 in 40 centers in Austria. WPAI, HRQoL (RAQoL, ankylosing spondylitis (AS)QoL and PsAQoL) questionnaires and disease activity (Clinical Disease Activity Index, CDAI, in RA and PsA; Bath Ankylosing Spondylitis Disease Activity Index, BASDAI, in axSpA) were assessed at baseline and months 3, 6, 12, 18, and 24. Association between WPAI and disease activity was tested using linear regression.ResultsWe enrolled 233 patients (RA, n = 95; axSpA, n = 69; PsA, n = 69), 110 patients were followed up to month 24. Mean age was 50.2 ± 14.2 years; 64% were female. Disease activity decreased from baseline to month 24 (RA: CDAI −24.3 ± 13.5; axSpA: BASDAI −4.4 ± 2.1, and PsA: CDAI −21.7 ± 8.5, p < 0.0001, each). Total work productivity impairment (TWPI), activity impairment and presenteeism subscores continuously decreased throughout month 24 in all indications: RA (−58.3 ± 23%, −62.6 ± 23.8% and −61.7 ± 23.3%, respectively as compared to baseline; p < 0.0001, each), axSpA (−34.4 ± 38.3%, p = 0.0117; −60.9 ± 25.9%, and −43.8 ± 26.6%, respectively, p ≤ 0.0001 both) and PsA (−35.8 ± 43.7%, p = 0.0186; −52.3 ± 25.4%, p < 0.0001; and −43.3 ± 33.5%, p = 0.0007, respectively). Absenteeism scores decreased only in RA patients (−9.2 ± 24.9%, p = 0.0234). HRQoL improved between baseline and month 24 (RAQoL: −12.6 ± 7.5; ASQoL: −8.0 ± 4.3; PsAQoL; −8.3 ± 6.4, p < 0.0001, each). TWPI, presenteeism and activity impairment strongly associated with disease activity throughout the study.ConclusionsThis real-world study confirms the benefit of golimumab on work productivity/daily activity impairment in Austrian RA, PsA, and axSpA patients.

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Section: Discussioncontrasting

confidence: 87%

Section: Discussionsupporting

confidence: 81%

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A Prospective Study to Evaluate the Impact of Golimumab Therapy on Work Productivity and Activity, and Quality of Life in Patients With Rheumatoid Arthritis, Psoriasis Arthritis and Axial Spondyloarthritis in a Real Life Setting in AUSTRIA. The GO-ACTIVE Study

Dejaco

Mueller

Zamani³

et al. 2022

Front. Med.

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“…(35,36,30,41). Health-related QoL improvements were demonstrated in the RWE studies, GO-NICE and GO-ART, that were consistent with EQ-5D-3L data in the GO-BEYOND pooled analysis (42,43). These studies represent a large body of evidence that support the findings in the GO-BEYOND pooled analysis, which showed large proportions of patients achieving meaningful improvements in disease activity in populations of RA, PsA and axSpA patients who have experienced difficulties and setbacks with previous TNFαi treatments.…”

Section: Discussionsupporting

confidence: 79%

Real-world effectiveness of golimumab in the treatment of patients with active rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who failed initial TNF-α inhibitor therapy: a pooled analysis of European prospective observational studie

Govoni,

Batalov,

Boumpas

et al. 2023

Clinical and Experimental Rheumatology

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ObjectiveRheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) patients often experience secondary non-response to a first-line tumour necrosis factor alpha inhibitor (TNFαi). This pooled analysis of six observational studies in Europe (GO-BEYOND program) provides an estimate of second-line golimumab (GLM) effectiveness for these rheumatic diseases. MethodsThe GO-BEYOND studies included common disease-specific endpoints allowing for a pooled analysis. Patients had discontinued one prior TNFαi (due to loss of efficacy, tolerability, or inconvenience) and were followed for 12 months after GLM initiation. Primary endpoints included the proportion of patients achieving low disease activity (LDA, DAS28-CRP<3.2) in RA, minimal disease activity (MDA, fulfilment of 5 of 7 outcome measures) in PsA, or low disease activity (ASDAS<2.1) in axSpA at 6 months. Disease activity at 3 and 12 months and quality of life (QoL; EQ-5D-3L) were also assessed. Adverse events were monitored. Protocol-specified analyses were based on observed data. 712 patients, (n=325, RA; 186, PsA; 201, axSpA), mean age was 54 years, 64% were female, and median disease duration was 5 years. Primary endpoints were achieved in 58.3% (RA), 45.5% (PsA), and 45.4% (axSpA) of patients; disease activity improvements were observed at 3 and 12 months and EQ-5D-3L results showed improved QoL over time. The treatment persistence rate at 12 months was 67.8% of patients. No new safety signals were observed. Results In ConclusionThis pooled analysis of the GO-BEYOND studies showed that treatment with GLM was effective and represented a valid second-line option for RA, PsA, and axSpA patients.

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“…Current evidence also supports prescribing bDMARDs or tsDMARDs as first‐line agents in treatment‐naive patients due to similar or greater treatment efficacy as well as cost savings (37–40). Additionally, bDMARDs and tsDMARDs have been reported to help patients regain normal physical function and improve work productivity (41–45), which could generate additional active and productive hours, resulting in a positive impact on the German economy, as shown by Himmler et al (46). However, as existing health care systems do not provide adequate cover for advanced medications in every instance, rheumatologists may not yet prefer them as first‐line therapy.…”

Section: Discussionmentioning

confidence: 99%

Health Resource Utilization and Associated Health Care Costs of Biologic Disease‐Modifying Antirheumatic Drugs in German Patients With Psoriatic Arthritis

Sewerin

Borchert²,

Meise³

et al. 2022

Arthritis Care & Research

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Objective To investigate health care costs associated with biologic disease‐modifying antirheumatic drugs (bDMARDs) in a German real‐world cohort of adult biologics‐naive patients with psoriatic arthritis (PsA). Methods Claims data from the Institute for Applied Health Research Berlin (InGef) research database for patients with a PsA diagnosis and bDMARD claims record (index date) between January 1, 2014, and December 31, 2017, and no bDMARD prescriptions for 365 days before the index date were retrospectively analyzed. Primary outcomes were determination of health care resource utilization and associated annual health care costs for overall and individual bDMARDs in the 12‐month pre‐index and post‐index periods. These outcomes were compared between persistent and nonpersistent groups. Nonpersistence was defined as treatment gap or switch to a bDMARD other than the index therapy. Results Among 10,954 patients with a PsA diagnosis, 348 were eligible. Although mean ± SD post‐index costs were significantly higher in the persistent group than the nonpersistent group (€27,869 ± 8,001 versus €21,897 ± 10,600, P < 0 .001) due to higher bDMARD acquisition costs (€23,996 ± 4,818 versus €16,427 ± 9,033, P < 0.001), persistence reduced inpatient treatment costs (–€760), outpatient treatment costs (–€192), other drug costs (–€724), and sick leave costs (–€601). Conclusion Although initiation of bDMARDs increased the total health care costs irrespective of persistence status, partial cost offsets were observed in the persistent patient population.

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Golimumab improves patient-reported outcomes in daily practice of inflammatory rheumatic diseases in Germany

Cited by 8 publications

References 21 publications

A Prospective Study to Evaluate the Impact of Golimumab Therapy on Work Productivity and Activity, and Quality of Life in Patients With Rheumatoid Arthritis, Psoriasis Arthritis and Axial Spondyloarthritis in a Real Life Setting in AUSTRIA. The GO-ACTIVE Study

A Prospective Study to Evaluate the Impact of Golimumab Therapy on Work Productivity and Activity, and Quality of Life in Patients With Rheumatoid Arthritis, Psoriasis Arthritis and Axial Spondyloarthritis in a Real Life Setting in AUSTRIA. The GO-ACTIVE Study

Real-world effectiveness of golimumab in the treatment of patients with active rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who failed initial TNF-α inhibitor therapy: a pooled analysis of European prospective observational studie

Health Resource Utilization and Associated Health Care Costs of Biologic Disease‐Modifying Antirheumatic Drugs in German Patients With Psoriatic Arthritis

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