Predicting the treatment response of certolizumab for individual adult patients with rheumatoid arthritis: protocol for an individual participant data meta-analysis

Luo, Yan; Chalkou, Konstantina; Yamada, Ryo; Funada, Satoshi; Salanti, Georgia; Furukawa, Toshi A

doi:10.1186/s13643-020-01401-x

Cited by 6 publications

(6 citation statements)

References 44 publications

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“…However, examples of pooling and analysis of full RCT data sets are beginning to appear. [6][7][8] In these examples, individual patient data are shared and meta-analytic methods used to evaluate patient characteristics that may modify treatment effects. Because such models could involve complex interactions, machine-learning approaches may offer particular advantages.…”

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confidence: 99%

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Building Predictive Models for Clinical Care—Where to Build and What to Predict?

Selby

Fireman

2021

JAMA Netw Open

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Coquet et al 1 evaluate the performance of a survival prediction model for patients with metastatic castration-resistant prostate cancer (CRPC). The model was developed using machine learning in data pooled from the control groups of 4 randomized clinical trials (RCTs). The model's parameters were then applied to a population of 513 patients with metastatic CRPC identified from the electronic health records (EHRs) of a cancer center over a 12-year period. After linkage with data from state and local cancer registries and the Social Security Death Index, the authors examined the model's performance in EHR data on these real-world patients. 1

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confidence: 99%

“…However, examples of pooling and analysis of full RCT data sets are beginning to appear . In these examples, individual patient data are shared and meta-analytic methods used to evaluate patient characteristics that may modify treatment effects.…”

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confidence: 99%

Building Predictive Models for Clinical Care—Where to Build and What to Predict?

Selby

Fireman

2021

JAMA Netw Open

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“…Internal validation is a commonly used method for evaluating models free of experimental and environmental conditions’ limitations ( Luo et al, 2020 ; Vasconcelos et al, 2023 ). In this study, we used 10-fold cross validation to conduct internal validation.…”

Section: Resultsmentioning

confidence: 99%

Simultaneous effect of different chromatographic conditions on the chromatographic retention of pentapeptide derivatives (HGRFG and NPNPT)

et al. 2023

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Introduction: Oligopeptides exhibit great prospects for clinical application and its separation is of great importance in new drug development.Methods: To accurately predict the retention of pentapeptides with analogous structures in chromatography, the retention times of 57 pentapeptide derivatives in seven buffers at three temperatures and four mobile phase compositions were measured via reversed-phase high-performance liquid chromatography. The parameters (kHA, kA, and pKa) of the acid–base equilibrium were obtained by fitting the data corresponding to a sigmoidal function. We then studied the dependence of these parameters on the temperature (T), organic modifier composition (φ, methanol volume fraction), and polarity (PmN parameter). Finally, we proposed two six-parameter models with (1) pH and T and (2) pH and φ or PmN as the independent variables. These models were validated for their prediction capacities by linearly fitting the predicted retention factor k-value and the experimental k-value.Results: The results showed that logkHA and logkA exhibited linear relationships with 1/T, φ or PmN for all pentapeptides, especially for the acid pentapeptides. In the model of pH and T, the correlation coefficient (R2) of the acid pentapeptides was 0.8603, suggesting a certain prediction capability of chromatographic retention. Moreover, in the model of pH and φ or PmN, the R2 values of the acid and neutral pentapeptides were greater than 0.93, and the average root mean squared error was approximately 0.3, indicating that the k-values could be effectively predicted.Discussion: In summary, the two six-parameter models were appropriate to characterize the chromatographic retention of amphoteric compounds, especially the acid or neutral pentapeptides, and could predict the chromatographic retention of pentapeptide compounds.

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“…The study protocol for this meta-analysis has been registered in PROSPERO (CRD42020157595) and published . The reporting adheres to the Preferred Reporting Items for Systematic Reviews and Meta-analyses of Individual Participant Data (PRISMA-IPD) statement .…”

Section: Methodsmentioning

confidence: 99%

“…The study protocol for this meta-analysis has been registered in PROSPERO ( CRD42020157595 ) and published. 14 The reporting adheres to the Preferred Reporting Items for Systematic Reviews and Meta-analyses of Individual Participant Data ( PRISMA-IPD ) statement. 15 As per the Ethical Guidelines for Medical and Health Research Involving Human Subjects in Japan, institutional review board approval and participant consent are not required for this study.…”

Section: Methodsmentioning

confidence: 99%

Estimating Patient-Specific Relative Benefit of Adding Biologics to Conventional Rheumatoid Arthritis Treatment

et al. 2023

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ImportanceCurrent evidence remains ambiguous regarding whether biologics should be added to conventional treatment of rheumatoid arthritis for specific patients, which may cause potential overuse or treatment delay.ObjectivesTo estimate the benefit of adding biologics to conventional antirheumatic drugs for the treatment of rheumatoid arthritis given baseline characteristics.Data SourcesCochrane CENTRAL, Scopus, MEDLINE, and the World Health Organization International Clinical Trials Registry Platform were searched for articles published from database inception to March 2, 2022.Study SelectionRandomized clinical trials comparing certolizumab plus conventional antirheumatic drugs with placebo plus conventional drugs were selected.Data Extraction and SynthesisIndividual participant data of the prespecified outcomes and covariates were acquired from the Vivli database. A 2-stage model was fitted to estimate patient-specific relative outcomes of adding certolizumab vs conventional drugs only. Stage 1 was a penalized logistic regression model to estimate the baseline expected probability of the outcome regardless of treatment using baseline characteristics. Stage 2 was a bayesian individual participant data meta-regression model to estimate the relative outcomes for a particular baseline expected probability. Patient-specific results were displayed interactively on an application based on a 2-stage model.Main Outcomes and MeasuresThe primary outcome was low disease activity or remission at 3 months, defined by 3 disease activity indexes (ie, Disease Activity Score based on the evaluation of 28 joints, Clinical Disease Activity Index, or Simplified Disease Activity Index).ResultsIndividual participant data were obtained from 3790 patients (2996 female [79.1%] and 794 male [20.9%]; mean [SD] age, 52.7 [12.3] years) from 5 large randomized clinical trials for moderate to high activity rheumatoid arthritis with usable data for 22 prespecified baseline covariates. Overall, adding certolizumab was associated with a higher probability of reaching low disease activity. The odds ratio for patients with an average baseline expected probability of the outcome was 6.31 (95% credible interval, 2.22-15.25). However, the benefits differed in patients with different baseline characteristics. For example, the estimated risk difference was smaller than 10% for patients with either low or high baseline expected probability.Conclusions and RelevanceIn this individual participant data meta-analysis, adding certolizumab was associated with more effectiveness for rheumatoid arthritis in general. However, the benefit was uncertain for patients with low or high baseline expected probability, for whom other evaluations were necessary. The interactive application displaying individual estimates may help with treatment selection.

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Predicting the treatment response of certolizumab for individual adult patients with rheumatoid arthritis: protocol for an individual participant data meta-analysis

Cited by 6 publications

References 44 publications

Building Predictive Models for Clinical Care—Where to Build and What to Predict?

Building Predictive Models for Clinical Care—Where to Build and What to Predict?

Simultaneous effect of different chromatographic conditions on the chromatographic retention of pentapeptide derivatives (HGRFG and NPNPT)

Estimating Patient-Specific Relative Benefit of Adding Biologics to Conventional Rheumatoid Arthritis Treatment

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