Long‐term retention of golimumab treatment in clinical practice in a large cohort of patients with rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis
Manuel Pombo‐SuárezDaniel Seoane‐MatoFederico Dı́az-GonzálezLuis Cea‐CalvoFernando Sánchez‐AlonsoMarta Sánchez‐JareñoVega JovaníB. García-MagallónOlga Martínez GonzálezCristina Campos‐FernándezJavier ManeroCèsar Díaz‐TornéC. Bohórquez HerasInmaculada Ros‐VilamajóY. Perez-VeraIsabel Castrejón
6
Citation
36
Reference
10
Related Paper
Citation Trend
Abstract:
Abstract Aim To assess the golimumab retention rate during up to 8 years of follow up, and any associated factors. Methods Retrospective analysis of the BIOBADASER (Spanish registry of biological drugs) database, assessing all adults who had ever started golimumab >6 months before the analysis for an approved indication (rheumatoid arthritis [RA], axial spondyloarthritis [SpA] or psoriatic arthritis [PsA]). Results Among 885 patients (RA 267, axial SpA 370, PsA 248) receiving 944 cycles of golimumab, the retention rate of golimumab was 71.1% (95% confidence interval: 68.0–73.9) at year 1% and 37.7% (95% CI: 33.3–42.1) at year 7 and at year 8. Retention was higher when golimumab was used as the first biological drug (81.7% at year 1, 49.9% at year 7, p < 0.001). In Cox regression analysis, factors associated with golimumab retention included use as first‐line therapy (hazard ratio [HR] for discontinuation 1.52 for second‐ and 1.79 for third/later‐line vs. first‐line), use in axial SpA or PsA rather than RA (HR for axial SpA vs. RA 0.59, for PsA vs. Rheumatoid arthritis 0.67), and treatment with concomitant methotrexate (HR 0.67). Factors associated with golimumab discontinuation were corticosteroid use (HR 1.46) and disease activity above median (HR 1.29) at golimumab initiation. Conclusion Based on this retrospective analysis of the BIOBADASER registry, nearly two‐fifths (37.7%) of adult rheumatology patients initiating golimumab will remain on treatment for 8 years, with a higher probability of retention in axial SpA or PsA indications and when golimumab is used as first biologic.Keywords:
Golimumab
Discontinuation
Retention rate
Discontinuation
Biological drugs
Spondylitis
Cite
Citations (0)
Abstract Objectives To investigate 6‐year drug survival (median: 48.5 months) of golimumab and predictors for lack of efficacy leading to golimumab discontinuation in Japanese patients with rheumatoid arthritis (RA) in routine practice. Methods This retrospective single‐center study included 60 patients with RA treated with golimumab from November 2011 to August 2020. Patients were divided into 2 groups (retention, n = 28; withdrawal due to lack of efficacy, n = 24). The retention rate was assessed using the Kaplan‐Meier method, and variables associated with golimumab discontinuation were identified using the Cox proportional hazard model. Results The prevalence of concomitant methotrexate and no biologics use was significantly higher in the retention than in the withdrawal group. Overall drug survival of golimumab was 66.3%, 48.3%, and 24.5% at 12, 36, and 72 months, respectively. There were statistical differences in retention rates among groups stratified by initiation dose, methotrexate, and biologics use. Multivariate analysis revealed the factor associated with golimumab discontinuation as history of 1 (hazards ratio: 4.42, 95% CI: 1.35‐19.93, P = .012) and ≥2 biologics use (7.49, 1.97‐36.27, P = .003). Conclusions Prior exposure of increasing number of biologics was identified as the most important factor negatively affecting long‐term golimumab retention in Japanese patients with RA.
Golimumab
Discontinuation
Retention rate
Cite
Citations (5)
We conducted a single-center, medical records review study of all patients with RA, PsA, and SpA on GLM treatment attending a large rheumatology department from 2010 to 2017. Times from start to end of GLM treatment were collected, as well as sociodemographic, clinical, and safety variables. Golimumab retention rate was estimated by the Kaplan-Meier method, and comparison across diseases was analyzed with the Mantel-Haenszel statistic (log-rank test). Cox proportional hazards regression models were used to identify factors associated with GLM discontinuation.In the study period, a total of 212 patients (61 RA, 48 PsA, 103 SpA) were prescribed GLM. Retention rates were 72% in the first year, 61% in the second, 56% in the third, and 38% at 5 years. Differences were statistically significant across diseases (median times to GLM discontinuation were 50.2, 46.0, and 38.7 months for RA, SpA, and PsA, respectively) and according to the number of previous biologic therapies (55.2 months in biologic-naive patients vs 14.0 months in patients with ≥2 previous biologics; p < 0.001). The use of concomitant conventional synthetic disease-modifying antirheumatic drugs was associated with a lower probability of discontinuation (hazards ratio [HR], 0.57; 95% confidence interval [CI], 0.33-0.97). Female sex (HR, 1.84; 95% CI, 1.07-3.17) and having used 2 biologics before GLM (HR, 2.99; 95% CI, 1.76-5.06) were associated with increased discontinuation rates. Twenty-three patients (10.9%) had at least 1 serious adverse event.In a real-life setting, GLM shows appropriate long-term safety-effectiveness ratio.
Golimumab
Discontinuation
Retention rate
Cite
Citations (6)
While current use of menopausal hormone therapy (MHT) reduces the risk of osteoporotic fractures, epidemiologic studies suggest that protection wears off rapidly after discontinuation of treatment. The authors identified 5,589 first osteoporotic fractures (2,235 major osteoporotic fractures) among 70,182 postmenopausal women from the French E3N cohort (1992–2008) and used Cox multivariate proportional hazards regression models to estimate hazard ratios. Persistence of protection against major osteoporotic fractures after MHT discontinuation was only observed when MHT had been used for at least 5 years, with a slightly more important decrease within the 5 years after discontinuation (compared with never use of MHT, hazard ratio = 0.68, 95% confidence interval: 0.50, 0.92) than beyond 5 years (hazard ratio = 0.83, 95% confidence interval: 0.69, 0.99); the P value for homogeneity between the 2 estimates was not significant. Oral estrogen use and transdermal estrogen use conveyed similar estimates in past users. Among current users, the authors confirmed a protective effect of MHT against risk of osteoporotic fractures. These findings, which relied on a number of MHT combinations, suggested that such therapies should be used for 5 years or more for reducing risk of fracture after treatment discontinuation.
Discontinuation
Hormone Therapy
Cite
Citations (19)
The tumor necrosis factor- α (TNF- α ) golimumab (GLM), that is a fully human monoclonal anti-body, was registered in Russia in 2012 to treat rheumatic diseases, such as rheumatoid arthritis (RA), ankylosing spondylitis, and psoriatic arthritis. Its distinguishing characteristics are a high affinity for TNF- α and easiness-to-use: the drug as a 0.5-ml solution is injected subcutaneously once monthly. The registration of the medication was followed by the implementation of a massive program of clinical trials. The randomized placebo-controlled GO-FORWARD, GO-BEFORE, and GO-AFTER studies have indicated that GLM is effective in patients with RA from different subgroups and has a favorable safety profile as compared to that of the entire class of biological agents. According to the data of these studies, GLM had a positive effect on the functional status and quality of life in patients with RA: there was a significantly greater decrease in HAQ scores in both the early and long open treatment phases (to 5 years) and in fatigability than in the control group (p=0.032), physical and mental health improvements, as shown by the SF-36 questionnaire, and a significant reduction in disability.
Golimumab
Cite
Citations (3)
Abstract Background In patients with rheumatic diseases, the use of biological (b) or targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) after discontinuation of tumor necrosis factor inhibitors (TNFi) is known to be effective. However, data on the use of TNFi after discontinuation of non-TNFi bDMARDs or tsDMARDs (non-TNFi) are scarce. This study assessed the 4-years golimumab retention in patients with rheumatic diseases when used after discontinuation of non-TNFi. Methods Adults with rheumatoid arthritis (RA; n = 72), psoriatic arthritis (PsA; n = 30) or axial spondyloarthritis (axSpA; n = 23) who initiated golimumab after discontinuation of non-TNFi from the Spanish registry of biological drugs (BIOBADASER) were analyzed retrospectively. The retention rate (drug survival or persistence) of golimumab up to 4 years was evaluated. Results The golimumab retention rate was 60.7% (51.4–68.8) at year 1, 45.9% (36.0–55.2) at year 2, 39.9% (29.8–49.7) at year 3 and 33.4% (23.0–44.2) at year 4. Retention rates did not differ significantly whether golimumab was used as second, third, or fourth/subsequent line of therapy ( p log-rank = 0.462). Golimumab retention rates were higher in axSpA or PsA patients than in RA patients ( p log-rank = 0.002). When golimumab was administered as third or fourth/subsequent line, the 4-years retention rate after discontinuation of non-TNFi was similar to that after discontinuation of TNFi. Conclusion In patients who discontinued non-TNFi, most of whom received golimumab as third/subsequent line of therapy, one-third of patients remained on golimumab at year 4. Retention rates were higher in patients with axSpA and PsA than in those with RA.
Golimumab
Discontinuation
Retention rate
Cite
Citations (0)
Background
Anti-TNF therapy has been a great advance in the treatment of rheumatic diseases. However, these drugs have a high cost and potentially severe adverse effects, therefore it would be useful to analyze their use at lower doses with a longer dosing interval.Objectives
The aim of this study is to analyze whether lengthening the recommended dosing interval with anti-TNF therapies in rheumatoid arthritis and psoriatic peripheral arthritis in remission provides good control of the disease.Methods
We collected the clinical data of patients diagnosed with rheumatoid arthritis (RA) and peripheral psoriatic arthritis (PSA) in subcutaneous anti-TNF therapy (adalimumab, etanercept and golimumab), which were in remission/low activity at two successive consultations and in which the anti-TNF dosing interval has been lengthened according to the following pattern: etanercept 50 mg/15 days, adalimumab 40 mg/21 days, and golimumab 50mg/5 weeks. In order to evaluate disease activity, we used the DAS28, serum C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) before changing the dosing interval at 6, 12, 18, 24 and 30 months of follow-up. Biostatistical analysis was performed using linear regression models.Results
We included a total of 67 patients from February 2011 (42 AR and 25 PSA) who were treated with anti-TNF therapy (39 with adalimumab, 23 with etanercept and 5 with golimumab). The mean DAS28 score at different intervals is shown in the table below. During follow-up, there were 9 interruptions in lengthening (4 RA and 5 PSA), 5 exacerbations and 3 transfers to another hospital. According to the data obtained, DAS28 in RA cases slightly increased with lengthening of the dosing interval but does not reach values exceeding low disease activity. Linear regression revealed a tendency that the adalimumab and biological therapy combined with methotrexate maintained low disease activity more efficiently.Conclusions
Although no statistically significant results were obtained due to the small number of patients, in all cases the disease control was achieved. Furthermore, better control was achieved with the combined use of biological therapy and methotrexate, as well as with adalimumab. However, a larger number of cases and longer follow-up period is needed in order to confirm that prolonging the anti-TNF dosing interval is useful for disease control.Disclosure of Interest
None declaredDOI
10.1136/annrheumdis-2014-eular.4944Golimumab
Erythrocyte sedimentation rate
Cite
Citations (0)
Although Ethiopia has implemented the Option B+ program over the past 7 years, loss to follow-up among HIV-positive women remains a major problem for antiretroviral therapy (ART) treatment. This study was conducted to investigate the number of women who dropped out of follow-up after the Option B+ program.A retrospective follow-up study was conducted among 403 pregnant and lactating women between June 2013 and December 2019 at health facilities in Northwest Ethiopia. The Cox proportional hazards regression model was used to identify predictors of loss to follow-up. The results were reported as hazard ratios with 95% confidence intervals (CIs) at a significance level of p = 0.05.The overall incidence rate of loss to follow-up was 9.4 per 1,000 person-months of observation (95% CI: 7.40-11.90). According to the multivariable Cox regression, rural residency [adjusted hazard ratio (AHR): 2.30; 95% CI: 1.08-4.88], being a Muslim religion follower (AHR: 2.44; 95% CI: 1.23-4.81), having no baseline viral load measurement (AHR: 4.21; 95% CI: 2.23-7.96), being on ART before enrolment (AHR: 0.30; 95% CI: 0.15-0.62), having drug side effects (AHR:1.82; 95% CI: 1.01-3.33), same-day ART initiation (AHR: 3.23; 95% CI: 1.53-6.84), and having suboptimal adherence level (AHR: 3.96; 95% CI: 2.18-7.19) were significant predictors of loss to follow-up.The incidence of loss to follow-up is lower as compared to evidence from most African countries but slightly higher than the WHO target. It is better to strengthen and expand viral load measurements for all women and to pay attention to women residing in rural areas with fair or poor adherence levels.
Cite
Citations (2)
Golimumab
Discontinuation
Cite
Citations (41)
Background: The impact of local recurrence and surgical resection margin status on survival in extremity soft-tissue sarcomas remains to be clearly defined. Our aim was to conduct a retrospective analysis of prospectively collected data to determine the prognostic relavance of positive resection margins and local recurrence for extremity soft-tissue sarcomas for survival. Methods: Three hundred and sixty-three patients who underwent resection of localized primary extremity soft-tissue sarcomas with curative intent were selected from the United States Department of Defense Automated Central Tumor Registry. Outcomes for local recurrence, distant recurrence, disease-specific survival, and overall survival were analyzed according to clinical, pathological, and treatment variables with use of the Kaplan-Meier method (log-rank test) and the multivariate Cox regression model. Results: Positive margins (hazard ratio, 1.99 [95% confidence interval, 1.15 to 3.45]), local recurrence (hazard ratio, 2.93 [95% confidence interval, 1.38 to 6.23]), and distant recurrence (hazard ratio, 12.13 [95% confidence interval, 5.97 to 24.65]) were significantly associated with overall survival on multivariate Cox regression analysis. However, for disease-specific survival, local recurrence was not significant and tumor size of >10 cm (hazard ratio, 2.83 [95% confidence interval, 1.15 to 6.95]), positive margins (hazard ratio, 1.95 [95% confidence interval, 1.05 to 3.63]), and distant recurrence (hazard ratio, 9.46 [95% confidence interval, 4.37 to 20.47]) were independent adverse prognostic factors. The disease-specific survival rate for patients with localized soft-tissue sarcomas was 89% (95% confidence interval, 85% to 92%) for five years and 75% (95% confidence interval, 70% to 81%) for ten years. Conclusions: Positive surgical margins are consistently associated with adverse survival-related outcomes in localized soft-tissue sarcomas of the extremity. Local recurrence had a significant impact on overall survival, but not on disease-specific survival. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Surgical margin
Log-rank test
Cite
Citations (64)