Quantitative Evaluations of Time‐Course and Treatment Effects of Systemic Agents for Psoriasis: A Model‐Based Meta‐Analysis

Checchio, Tina; Ahadieh, Sima; Gupta, Pankaj; Mandema, Jaap W.; Puig, Luís; Wołk, Robert; Valdez, Hernán; Tan, Huaming; Krishnaswami, Sriram; Tallman, Anna M.; Kaur, Mandeep; Ito, Kei

doi:10.1002/cpt.732

Cited by 21 publications

(23 citation statements)

References 12 publications

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“…A joint model of the mean change in the IRLS score from baseline or the CGI-I response rate was established to describe the dose-effect and time-effect relationships for the RLS drugs. This structure model was also referred to in studies by Checchio et al 15 and Mandema et al 16 E kijm = f drug, kijm + f placebo, im…”

Section: Structure Modelmentioning

confidence: 87%

“…A joint model of the mean change in the IRLS score from baseline or the CGI‐I response rate was established to describe the dose‐effect and time‐effect relationships for the RLS drugs. This structure model was also referred to in studies by Checchio et al and Mandema et al

{normalE}_{kijm} = {normalf}_{drug, kijm} + {normalf}_{placebo, im}

\begin{matrix} true \\ right {normalf}_{drug, kijm} & = & left \frac{{normalE}_{\max, drug, ki} \times Dos {normale}_{kij}}{E {normalD}_{50, ki} + Dos {normale}_{kij}} \\ left \times true(1 - {normale}^{- {normalk}_{drug, ki} \times tim {normale}_{kijm}} true) \end{matrix}

{normalf}_{placebo, im} = {normalE}_{\max, placebo, i} \times (1 - e^{- k_{placebo, normali} \times tim e_{im}})

…”

Section: Model Establishmentmentioning

confidence: 89%

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Quantitative Comparison of the Efficacies of 5 First‐Line Drugs for Primary Restless Leg Syndrome

Zhang

et al. 2019

The Journal of Clinical Pharma

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Comparative analyses of the efficacies of dopaminergic agonists (pramipexole, ropinirole, and rotigotine patch) and α‐2‐δ ligands (gabapentin enacarbil and pregabalin) for treatment of primary restless leg syndrome (RLS) are lacking because of the few head‐to‐head clinical trials. A model‐based meta‐analysis approach was employed to quantitatively compare the efficacies of these 5 first‐line RLS drugs. Longitudinal efficacy data of RLS drugs were collected from published eligible literature. Mean changes in both the International Restless Leg Syndrome Study Group (IRLS) rating scale and Clinical Global Impression Improvement (CGI‐I) scale response rate were analyzed. A study‐level population pharmacodynamic model was used to fit the dose‐effect relationship and to describe the therapeutic effect over time for RLS drugs and placebo, and the typical efficacies of these drugs were compared. The onset of action was rapid for RLS drugs. In the placebo group, typical maximum IRLS reduction (Emax,IRLS) and CGI‐I response rate (Emax,CGI‐I) were –9.34 points and 48.2%, respectively. After deducting placebo effects, we found that the baseline IRLS score was significantly correlated with the Emax,IRLS of dopaminergic agonists. Typical Emax,IRLS of dopaminergic agonists was expressed as −7.7−0.682×( baseline IRLS score −24) points. Typical Emax,IRLS values of pregabalin and gabapentin enacarbil were –5.95 points and –4.00 points, respectively. The therapeutic effect of dopaminergic agonists was found to be associated with baseline symptom severity. In RLS patients with more severe symptoms, the therapeutic effect of dopaminergic agonists tended to be better than that of α‐2‐δ ligands.

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Section: Structure Modelmentioning

confidence: 87%

{normalE}_{kijm} = {normalf}_{drug, kijm} + {normalf}_{placebo, im}

\begin{matrix} true \\ right {normalf}_{drug, kijm} & = & left \frac{{normalE}_{\max, drug, ki} \times Dos {normale}_{kij}}{E {normalD}_{50, ki} + Dos {normale}_{kij}} \\ left \times true(1 - {normale}^{- {normalk}_{drug, ki} \times tim {normale}_{kijm}} true) \end{matrix}

{normalf}_{placebo, im} = {normalE}_{\max, placebo, i} \times (1 - e^{- k_{placebo, normali} \times tim e_{im}})

…”

Section: Model Establishmentmentioning

confidence: 89%

Quantitative Comparison of the Efficacies of 5 First‐Line Drugs for Primary Restless Leg Syndrome

Zhang

et al. 2019

The Journal of Clinical Pharma

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“…Based on the results of OPT Compare (NCT01241591), tofacitinib 10 mg BID had similar efficacy to etanercept 50 mg twice weekly (PASI 75: 63·6% and 58·5%, respectively; PGA response: 68·2% and 66·3%, respectively), whereas 5 mg BID did not meet the noninferiority criteria (PASI 75: 39·5%; PGA response: 47·1%) . A meta‐analysis conducted by Pfizer has shown the efficacy of tofacitinib 5 mg BID to be similar to those of oral methotrexate and etanercept 25 mg twice weekly, and numerically higher than with the oral psoriasis therapies acitretin and apremilast . The meta‐analysis also showed the efficacy of tofacitinib 10 mg BID to be in the range of those of injectable tumour necrosis factor antagonists (currently the most widely prescribed biological drugs for psoriasis), similar to that of ciclosporin, and greater than those of other oral treatments (apremilast, acitretin, oral methotrexate and fumarates) …”

Section: Discussionmentioning

confidence: 99%

Benefit–risk profile of tofacitinib in patients with moderate‐to‐severe chronic plaque psoriasis: pooled analysis across six clinical trials

et al. 2018

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“…Weight was introduced according to the standard error of fitted values . The sample size ( N ij ) in each arm of each trial ensured that more influence was imposed by the larger studies as shown in the following equation:

Weight = \sqrt{\frac{P false(1 - P false)}{N}}

…”

Section: Methodsmentioning

confidence: 99%

Model‐Based Meta‐Analysis in Ankylosing Spondylitis: A Quantitative Comparison of Biologics and Small Targeted Molecules

Feng

et al. 2019

Clin Pharma and Therapeutics

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Information on the comparative efficacy is important for drug development as well as drug therapy. Up to now, the relative efficacy of approved biologics and many agents under investigation in ankylosing spondylitis (AS) are still unclear. The objective of this study was to quantify the relative efficacy and time course of various treatments measured by the Ankylosing Spondylitis Assessment Study group response criteria 20 scores (ASAS20), change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Functional Index (BASFI). There were 34 double‐blinded trials of 10 biologics and small molecules encompassing 5,339 patients with AS were included in this analysis. Three mathematical models with nonparametric placebo estimations were used to describe the longitudinal profile for the above three efficacy measures. The results detected significant differences among included treatments, and infliximab and golimumab were found to have the highest efficacy in given dosage regimens across all measures.

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Quantitative Evaluations of Time‐Course and Treatment Effects of Systemic Agents for Psoriasis: A Model‐Based Meta‐Analysis

Cited by 21 publications

References 12 publications

Quantitative Comparison of the Efficacies of 5 First‐Line Drugs for Primary Restless Leg Syndrome

Quantitative Comparison of the Efficacies of 5 First‐Line Drugs for Primary Restless Leg Syndrome

Benefit–risk profile of tofacitinib in patients with moderate‐to‐severe chronic plaque psoriasis: pooled analysis across six clinical trials

Model‐Based Meta‐Analysis in Ankylosing Spondylitis: A Quantitative Comparison of Biologics and Small Targeted Molecules

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