Persistence with golimumab in immune-mediated rheumatic diseases: a systematic review of real-world evidence in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis

Svedbom, Axel; Storck, Chiara; Kachroo, Sumesh; Govoni, M.; Khalifa, Ayman M.

doi:10.2147/ppa.s128665

Cited by 26 publications

(33 citation statements)

References 42 publications

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“…Factors for which no significant differences were found included smoking status and disease duration. The TNFi‐IR finding is consistent with previous studies in which increased drug survival with golimumab for TNFi‐naïve patients has been observed and seems to be generalizable to many bDMARDs in RA. Similar to the results for tofacitinib, high BMI has previously been reported as a predictor for discontinuation of etanercept treatment in RA .…”

Section: Discussionsupporting

confidence: 91%

“…In a retrospective study, persistence of RA therapy (2‐year drug survival) was higher for tumor necrosis factor inhibitors (TNFis) than conventional synthetic DMARDs (csDMARDs; 38.7% and 29.5%, respectively) . A systematic review of studies from clinical practice indicated that the persistence of golimumab therapy (2‐year drug survival rates ranging from 40% to 77%) may be higher than for other TNFis . In a longitudinal observational study of patients with RA receiving bDMARDs between 1999 and 2013, discontinuations were mainly due to AEs (45.8%) and lack of efficacy (40.8%) .…”

Section: Introductionmentioning

confidence: 99%

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Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open‐Label, Long‐Term Extension Studies up to 9.5 Years

Pope

Keystone

Jamal

et al. 2019

ACR Open Rheumatology

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ObjectiveTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This post hoc analysis evaluated tofacitinib persistence in patients with RA in long‐term extension (LTE) studies up to 9.5 years.MethodsData were pooled from two LTE studies: ORAL Sequel (NCT00413699) and Study A3921041 (NCT00661661). Patients received tofacitinib 5 or 10 mg twice daily (BID), as monotherapy or with background conventional synthetic disease‐modifying antirheumatic drugs. Kaplan‐Meier estimates for tofacitinib drug survival and reasons for discontinuation were evaluated. Baseline factors were analyzed as predictors of persistence.ResultsIn 4967 tofacitinib‐treated patients entering LTE studies, mean (maximum) treatment duration was 3.5 (9.4) years. Median drug survival (95% confidence interval) was 4.9 (4.7, 5.1) years. Estimated 2‐ and 5‐year drug survival rates were 75.5% and 49.4%, respectively. Median drug survival was similar between the tofacitinib 5 and 10 mg BID groups, and slightly higher for patients receiving tofacitinib monotherapy versus combination therapy. Overall, 50.7% of patients discontinued tofacitinib; of these, 47.2% were due to adverse events and 7.1% for lack/loss of efficacy. An increased risk of discontinuation was associated with baseline diabetes, hypertension, negative anticyclic citrullinated peptide (anti‐CCP), negative rheumatoid factor (RF), and inadequate response to tumor necrosis factor inhibitors (TNFi‐IR).ConclusionMedian drug survival of tofacitinib‐treated patients participating in LTE studies was approximately 5 years and was similar for tofacitinib dosed at 5 and 10 mg BID. Reduced drug survival was associated with negative anti‐CCP/RF status, TNFi‐IR, and certain comorbidities. These data support tofacitinib use for long‐term management of RA.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open‐Label, Long‐Term Extension Studies up to 9.5 Years

Pope

Keystone

Jamal

et al. 2019

ACR Open Rheumatology

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“…GOL served as the anchor point in this analysis because a recent review concluded that GOL might be associated with higher persistence rates in a real-world setting [25]. …”

Section: Methodsmentioning

confidence: 99%

Persistence with Biological Disease-modifying Antirheumatic Drugs and Its Associated Resource Utilization and Costs

Sruamsiri

Kameda

Mahlich

2018

Drugs - Real World Outcomes

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ObjectiveThe study assessed persistence rates of biological disease-modifying antirheumatic drugs (bDMARDs) for the treatment of rheumatoid arthritis in Japan and compared resource utilization and treatment costs between persistence and non-persistence groups.MethodsData were extracted from a Japanese claims database between 2009 and 2015. bDMARD-naïve patients were identified and included in the final analysis. Survival analysis was used to estimate 1-year persistence rates for current bDMARDs. Propensity score matching was applied to control for potential treatment selection bias. Resource utilization and healthcare costs were calculated 1 year before and after initiation of bDMARDs and compared between persistence and non-persistence groups.ResultsA total of 6153 bDMARD-naïve patients were identified and the overall 1-year persistence rate was 85% (95% CI 84–86). Overall, 1-year outpatient visits increased from 10 at baseline to 16 after bDMARD treatment, while the number of hospital admissions declined from 3.3 to 1.6. The non-persistence group had a larger increase in outpatient visits after bDMARD initiation compared with the persistence group (8–16 vs. 10–16, respectively) and a smaller decrease in hospital admissions (3.1–1.9 vs. 3.5–1.4, respectively). Persistence was associated with a reduction in total healthcare costs of US$760.ConclusionsJapanese bDMARD-naïve patients with RA have a high persistence rate with those treatments. The reduction in medication costs in non-persistent patients is offset by higher hospitalization costs, making non-persistence more expensive.Electronic supplementary materialThe online version of this article (10.1007/s40801-018-0139-8) contains supplementary material, which is available to authorized users.

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“…In patients with RA who had experienced failure on other anti-TNFα agents, the 5-year retention rate for golimumab was approximately 40% [11]. Studies in a real-world setting have also indicated a high probability of persistence with golimumab treatment in patients with RA, axial SpA or PsA, with 3-year retention rates generally around 60% when it was used as the first biological drug and 50-60% when it was given as second-line biological treatment [12,13].…”

Section: Introductionmentioning

confidence: 99%

Factors associated with long-term retention of treatment with golimumab in a real-world setting: an analysis of the Spanish BIOBADASER registry

et al. 2018

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The retention rate of a biological drug (percentage of patients remaining on treatment over time) provides an index of a drug's overall effectiveness. The golimumab retention rate as first-line biological therapy was high in clinical trial extensions lasting 5 years. Real-world studies also indicate good retention rates but have been of shorter duration. The probability of retention with golimumab treatment was assessed, as any line of anti-tumor necrosis factor-alpha therapy, for up to 5 years in patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) or psoriatic arthritis (PsA), associated factors were analyzed. A retrospective database analysis of the Spanish registry of patients with rheumatic disorders receiving biological drugs (BIOBADASER) was performed. Among 353 patients, 29.8% had RA, 41.6% SpA and 28.6% PsA. Golimumab was the first biological drug in 40.1% of patients, second in 30.1% and third/later in 29.8%. The overall probability of retention of golimumab at years 1, 2, 3, 4 and 5 was 85.9% (95% confidence interval 81.4-89.5%), 73.7% (67.1-79.1%), 68.5% (60.5-75.1%), 60.6% (50.2-69.5%) and 57.1% (44.9-67.5%), respectively. Retention was similar across indications (p = 0.070) but was greater when golimumab was used as the first biological agent compared with later therapy lines (p < 0.001). Factors associated with higher retention of golimumab treatment (Cox regression) were use as a first-line biological and concomitant methotrexate treatment; corticosteroid need was associated with lower retention. The long-term probability of golimumab retention was high in this real-world study of patients with rheumatic diseases, especially when used as the first biological drug.

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Persistence with golimumab in immune-mediated rheumatic diseases: a systematic review of real-world evidence in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis

Cited by 26 publications

References 42 publications

Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open‐Label, Long‐Term Extension Studies up to 9.5 Years

Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open‐Label, Long‐Term Extension Studies up to 9.5 Years

Persistence with Biological Disease-modifying Antirheumatic Drugs and Its Associated Resource Utilization and Costs

Factors associated with long-term retention of treatment with golimumab in a real-world setting: an analysis of the Spanish BIOBADASER registry

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