Cargando…

A Meta-Analysis Evaluating the Effectiveness and Safety of Upadacitinib in Treating Rheumatoid Arthritis in Patients With Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs

Upadacitinib, an oral Janus kinase (JAK) inhibitor, is used to manage rheumatoid arthritis. The objective was to generate statistical evidence from the existing data for upadacitinib efficacy and safety in various treatment regimens with different dosages in active rheumatoid arthritis patients. We...

Descripción completa

Detalles Bibliográficos
Autores principales: Panchal, Viraj, Vyas, Bhavya H, Sivasubramanian, Barath Prashanth, Panchal, Kanan, Patel, Harshank
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cureus 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9976645/
https://www.ncbi.nlm.nih.gov/pubmed/36874682
http://dx.doi.org/10.7759/cureus.34384
_version_ 1784899127891460096
author Panchal, Viraj
Vyas, Bhavya H
Sivasubramanian, Barath Prashanth
Panchal, Kanan
Patel, Harshank
author_facet Panchal, Viraj
Vyas, Bhavya H
Sivasubramanian, Barath Prashanth
Panchal, Kanan
Patel, Harshank
author_sort Panchal, Viraj
collection PubMed
description Upadacitinib, an oral Janus kinase (JAK) inhibitor, is used to manage rheumatoid arthritis. The objective was to generate statistical evidence from the existing data for upadacitinib efficacy and safety in various treatment regimens with different dosages in active rheumatoid arthritis patients. We searched PubMed, Cochrane, and ClinicalTrials.gov using PRISMA guidelines, providing data on the efficacy and safety of upadacitinib versus placebo in rheumatoid arthritis. 20% improvement in the American College of Rheumatology (ACR20) score response at 12 weeks was the primary outcome measure. Safety in adverse events, infections, or hepatic dysfunction was considered. The Mantel-Haenszel formula with random effect was used for the pooled odds ratio (OR) at a 95% confidence interval (CI) for dichotomous data. Meta-analysis was performed using RevMan version 5.4. Statistical heterogeneity was reported using I2 statistics; I2 > 75% was considered significant heterogeneity. A P value of less than 0.05 was considered significant. Data from 3233 patients were included in the analysis. The use of upadacitinib was associated with increased rates of achieving an ACR20 response compared with placebo (pooled OR 3.71; 95% CI 3.26-4.23; p-value <0.00001). Compared to a placebo, a 12 mg twice daily dose had the greatest effect, followed by a 15 mg once daily dose. Compared to the placebo, the incidence of any adverse event (pooled OR 1.66; 95% CI 1.36-2.02; p-value 0.0001) and infection (pooled OR 1.46; 95% CI 1.23-1.74; p-value 0.001) was found to be significantly higher in upadacitinib. Other adverse events, such as hepatic disorders and herpes zoster infections, were not statistically significant (p-value> 0.05). Maximum adverse events were seen at 12 mg twice daily. Upadacitinib, 15 mg once daily in combination with Methotrexate, was the most efficacious treatment regimen and was not associated with a significant risk for treatment-related adverse events in rheumatoid arthritis patients.
format Online
Article
Text
id pubmed-9976645
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Cureus
record_format MEDLINE/PubMed
spelling pubmed-99766452023-03-02 A Meta-Analysis Evaluating the Effectiveness and Safety of Upadacitinib in Treating Rheumatoid Arthritis in Patients With Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs Panchal, Viraj Vyas, Bhavya H Sivasubramanian, Barath Prashanth Panchal, Kanan Patel, Harshank Cureus Internal Medicine Upadacitinib, an oral Janus kinase (JAK) inhibitor, is used to manage rheumatoid arthritis. The objective was to generate statistical evidence from the existing data for upadacitinib efficacy and safety in various treatment regimens with different dosages in active rheumatoid arthritis patients. We searched PubMed, Cochrane, and ClinicalTrials.gov using PRISMA guidelines, providing data on the efficacy and safety of upadacitinib versus placebo in rheumatoid arthritis. 20% improvement in the American College of Rheumatology (ACR20) score response at 12 weeks was the primary outcome measure. Safety in adverse events, infections, or hepatic dysfunction was considered. The Mantel-Haenszel formula with random effect was used for the pooled odds ratio (OR) at a 95% confidence interval (CI) for dichotomous data. Meta-analysis was performed using RevMan version 5.4. Statistical heterogeneity was reported using I2 statistics; I2 > 75% was considered significant heterogeneity. A P value of less than 0.05 was considered significant. Data from 3233 patients were included in the analysis. The use of upadacitinib was associated with increased rates of achieving an ACR20 response compared with placebo (pooled OR 3.71; 95% CI 3.26-4.23; p-value <0.00001). Compared to a placebo, a 12 mg twice daily dose had the greatest effect, followed by a 15 mg once daily dose. Compared to the placebo, the incidence of any adverse event (pooled OR 1.66; 95% CI 1.36-2.02; p-value 0.0001) and infection (pooled OR 1.46; 95% CI 1.23-1.74; p-value 0.001) was found to be significantly higher in upadacitinib. Other adverse events, such as hepatic disorders and herpes zoster infections, were not statistically significant (p-value> 0.05). Maximum adverse events were seen at 12 mg twice daily. Upadacitinib, 15 mg once daily in combination with Methotrexate, was the most efficacious treatment regimen and was not associated with a significant risk for treatment-related adverse events in rheumatoid arthritis patients. Cureus 2023-01-30 /pmc/articles/PMC9976645/ /pubmed/36874682 http://dx.doi.org/10.7759/cureus.34384 Text en Copyright © 2023, Panchal et al. https://creativecommons.org/licenses/by/3.0/This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Internal Medicine
Panchal, Viraj
Vyas, Bhavya H
Sivasubramanian, Barath Prashanth
Panchal, Kanan
Patel, Harshank
A Meta-Analysis Evaluating the Effectiveness and Safety of Upadacitinib in Treating Rheumatoid Arthritis in Patients With Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs
title A Meta-Analysis Evaluating the Effectiveness and Safety of Upadacitinib in Treating Rheumatoid Arthritis in Patients With Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs
title_full A Meta-Analysis Evaluating the Effectiveness and Safety of Upadacitinib in Treating Rheumatoid Arthritis in Patients With Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs
title_fullStr A Meta-Analysis Evaluating the Effectiveness and Safety of Upadacitinib in Treating Rheumatoid Arthritis in Patients With Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs
title_full_unstemmed A Meta-Analysis Evaluating the Effectiveness and Safety of Upadacitinib in Treating Rheumatoid Arthritis in Patients With Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs
title_short A Meta-Analysis Evaluating the Effectiveness and Safety of Upadacitinib in Treating Rheumatoid Arthritis in Patients With Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs
title_sort meta-analysis evaluating the effectiveness and safety of upadacitinib in treating rheumatoid arthritis in patients with inadequate response to disease-modifying anti-rheumatic drugs
topic Internal Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9976645/
https://www.ncbi.nlm.nih.gov/pubmed/36874682
http://dx.doi.org/10.7759/cureus.34384
work_keys_str_mv AT panchalviraj ametaanalysisevaluatingtheeffectivenessandsafetyofupadacitinibintreatingrheumatoidarthritisinpatientswithinadequateresponsetodiseasemodifyingantirheumaticdrugs
AT vyasbhavyah ametaanalysisevaluatingtheeffectivenessandsafetyofupadacitinibintreatingrheumatoidarthritisinpatientswithinadequateresponsetodiseasemodifyingantirheumaticdrugs
AT sivasubramanianbarathprashanth ametaanalysisevaluatingtheeffectivenessandsafetyofupadacitinibintreatingrheumatoidarthritisinpatientswithinadequateresponsetodiseasemodifyingantirheumaticdrugs
AT panchalkanan ametaanalysisevaluatingtheeffectivenessandsafetyofupadacitinibintreatingrheumatoidarthritisinpatientswithinadequateresponsetodiseasemodifyingantirheumaticdrugs
AT patelharshank ametaanalysisevaluatingtheeffectivenessandsafetyofupadacitinibintreatingrheumatoidarthritisinpatientswithinadequateresponsetodiseasemodifyingantirheumaticdrugs
AT panchalviraj metaanalysisevaluatingtheeffectivenessandsafetyofupadacitinibintreatingrheumatoidarthritisinpatientswithinadequateresponsetodiseasemodifyingantirheumaticdrugs
AT vyasbhavyah metaanalysisevaluatingtheeffectivenessandsafetyofupadacitinibintreatingrheumatoidarthritisinpatientswithinadequateresponsetodiseasemodifyingantirheumaticdrugs
AT sivasubramanianbarathprashanth metaanalysisevaluatingtheeffectivenessandsafetyofupadacitinibintreatingrheumatoidarthritisinpatientswithinadequateresponsetodiseasemodifyingantirheumaticdrugs
AT panchalkanan metaanalysisevaluatingtheeffectivenessandsafetyofupadacitinibintreatingrheumatoidarthritisinpatientswithinadequateresponsetodiseasemodifyingantirheumaticdrugs
AT patelharshank metaanalysisevaluatingtheeffectivenessandsafetyofupadacitinibintreatingrheumatoidarthritisinpatientswithinadequateresponsetodiseasemodifyingantirheumaticdrugs