Patient and Physician Expectations of Add‐On Treatment With Golimumab for Rheumatoid Arthritis: Relationships Between Expectations and Clinical and Quality of Life Outcomes

Dasgupta, Bhaskar; Combe, Bernard; Louw, Ingrid; Wollenhaupt, J.; Zerbini, Cristiano A F; Beaulieu, André; Schulze‐Koops, Hendrik; Durez, Patrick; Wolff, Verónica; Yao, Ruji; Weng, Haoling H.; Govoni, M.; Vastesaeger, Nathan

doi:10.1002/acr.22371

Cited by 13 publications

(12 citation statements)

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“…However, other real-world studies have suggested that retention is at least as good, and possibly better, with golimumab than with some other TNFα inhibitors over 3 years [5,21]. Low immunogenicity, good tolerability with a very low percentage of injection-related side effects and ease of use (1-month dosing and easy-touse device) can account for better patient acceptance of the drug and, ultimately, high golimumab retention rates [22]. In the current study, regression analysis confirmed that the probability of continuing treatment with golimumab was higher when it was used as the first biological agent rather than as second-or third-line/later biological therapy.…”

Section: Discussionmentioning

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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Section: Discussionmentioning

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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“…For example, patients’ high expectations may be shaped by general optimism, attitudes, and advertisements or other media representations. Although HCPs may generally anticipate that a medication will be effective, their expectations may be refined by considering individual patient characteristics such as age and disease severity [ 15 ]. This discrepancy of efficacy expectations between consumers and HCPs may be an additional reason relatively more DI reports were submitted by consumers.…”

Section: Discussionmentioning

confidence: 99%

An Evaluation of “Drug Ineffective” Postmarketing Reports in Drug Safety Surveillance

Misu

Kortepeter

Muñoz

et al. 2018

Drugs - Real World Outcomes

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IntroductionThe most commonly reported adverse event, based on frequency of Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs), in the US FDA Adverse Event Reporting System (FAERS) database is “drug ineffective” (DI). This study aimed to describe the DI reports and provide data to support recommendations on how to best evaluate these reports.MethodsWe characterized all FAERS reports coded with the MedDRA PT “drug ineffective” received between 1 September 2012 and 31 August 2016 using all other FAERS reports as a comparator. Additionally, we conducted a manual evaluation to identify informative data elements in the report narratives.ResultsDuring the study period, 247,513 (6.4% of all FAERS reports) DI reports were entered in FAERS. Compared with non-DI reports, DI reports were more likely to be reported by consumers (69.8 vs. 48.1%) and less likely to report a serious outcome (26.2 vs. 56.3%). Most DI reports (88%) were from the USA. Manual evaluation of 552 sample US reports identified 43 reports (7.8%) deemed “useful”; a higher proportion of “useful” reports provided a batch or lot number (39.5 vs. 17.2%) and were coded with additional PTs beyond “drug ineffective” (83.7 vs. 59.2%), the most frequent of which were “product quality issue” (23.3%) and “product substitution issue” (18.6%).ConclusionsDI was the most frequently reported adverse event in the FAERS database; however, the yield from these reports in terms of usefulness from a pharmacovigilance perspective was low. Efficient strategies are needed to identify which DI reports are more likely to contain useful information.

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“…Although AUC in the ROC analysis of the prediction models was relatively high, not all factors that may affect response were included in the model. For example, patient expectations about effectiveness of treatment have been shown to be associated with remission [ 20 ]. The very large patient numbers are a clear strength of this analysis.…”

Section: Discussionmentioning

confidence: 99%

Prediction of remission and low disease activity in disease-modifying anti-rheumatic drug-refractory patients with rheumatoid arthritis treated with golimumab

et al. 2016

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Objective. To create a tool to predict probability of remission and low disease activity (LDA) in patients with RA being considered for anti-TNF treatment in clinical practice.Methods. We analysed data from GO-MORE, an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ⩾3.2) despite DMARD therapy. Patients received 50 mg s.c. golimumab (GLM) once monthly for 6 months. In secondary analyses, regression models were used to determine the best set of baseline factors to predict remission (DAS28-ESR <2.6) at month 6 and LDA (DAS28-ESR ⩽3.2) at month 1.Results. In 3280 efficacy-evaluable patients, of 12 factors included in initial regression models predicting remission or LDA, six were retained in final multivariable models. Greater likelihood of LDA and remission was associated with being male; younger age; lower HAQ, ESR (or CRP) and tender joint count (or swollen joint count) scores; and absence of comorbidities. In models predicting 1-, 3- and 6-month LDA or remission, area under the receiver operating curve was 0.648–0.809 (R2 = 0.0397–0.1078). The models also predicted 6-month HAQ and EuroQoL-5-dimension scores. A series of matrices were developed to easily show predicted rates of remission and LDA.Conclusion. A matrix tool was developed to show predicted GLM treatment outcomes in patients with RA, based on a combination of six baseline characteristics. The tool could help provide practical guidance in selection of candidates for anti-TNF therapy.

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Patient and Physician Expectations of Add‐On Treatment With Golimumab for Rheumatoid Arthritis: Relationships Between Expectations and Clinical and Quality of Life Outcomes

Cited by 13 publications

References 7 publications

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

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

An Evaluation of “Drug Ineffective” Postmarketing Reports in Drug Safety Surveillance

Prediction of remission and low disease activity in disease-modifying anti-rheumatic drug-refractory patients with rheumatoid arthritis treated with golimumab

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