Study Metrics
Total Sample
1231
Treatment Group
314
Control Group
917
Covariates
18
PICO Comparisons
1
Quality Indicators
Transparency
High
DAG Usage
No
QBA Performed
No
Study Information
| First Author: | Yiu |
| Publication Year: | 2021 |
| DOI: | https://doi.org/10.1001/jamadermatol.2020.4202 |
| Preprint: | No preprint |
Institution & Funding
| Institution Type: | Academic |
| Institutions: | University of Manchester, Newcastle University Medical School, Newcastle Hospitals NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, Salford Royal NHS Foundation Trust |
| Funding: | Declared: Public, professional society, private |
| Funding Institutions: | This research was supported in part by the NIHR Manchester Biomedical Research Centre and the NIHR Newcastle Biomedical Research Centre. Dr Yiu was funded by an NIHR Academic Clinical Lectureship through The University of Manchester. Drs Griffiths and Warren were funded in part by grant MR/L011808/1 from the Medical Research Council. The study group British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) is coordinated by The University of Manchester and funded by the British Association of Dermatologists (BAD). The BAD receives income from AbbVie, Almirall, Amgen, Celgene, Janssen, LEO Pharma, Lilly, Novartis, Samsung Bioepis, Sandoz Hexal AG, and UCB Pharma Ltd for providing pharmacovigilance services. This income finances a separate contract between the BAD and The University of Manchester that coordinate BADBIR. BADBIR acknowledges the support of the NIHR through the clinical research networks and the contribution made by clinical research associates who continue to facilitate recruitment into the registry. |
Study Context
| Disease: | Psoriasis |
| Disease Category: | Immunology |
| Data Type: | Registry |
| Number of Data Sources: | 1 |
| Geography: | UK and Ireland |
| Eligible Sample: | 1231.0 |
| Number of Treatments: | 2 |
Analytical Methods
| Missing Data Method: | Complete case |
| Matching Method: | PS weighted |
| Analysis Method: | Generalized linear models with a log link |
Quality Methods
Directed Acyclic Graph (DAG)
Not Used
Quantitative Bias Analysis (QBA)
Not Performed
Target Trial Information
| Target Trial Name: | CLEAR |
| Registration Number: | NCT02074982 |
| Target Trial DOI: | https://doi.org/10.1016/j.jaad.2015.05.013, https://doi.org/10.1016/j.jaad.2016.08.008 |
TTE vs RCT Comparisons
Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.
PASI<=2 after 12 months
CLEAR
RR
Efficacy
Population
patients with chronic plaque psoriasis aged > 18 years with PASI ≥ 12
Intervention
secukinumab
Comparison
ustekinumab
Outcome
PASI<=2 after 12 months
RCT Result
1.24
95% CI: [1.11, 1.37]
vs
TTE Result
1.28
95% CI: [1.06, 1.55]
Concordance Assessment
Confidence Interval Overlap:
Yes
CIs overlap, suggesting concordance
CIs overlap, suggesting concordance
Direction Agreement:
Same Direction
Both point to similar conclusion
Both point to similar conclusion
Transparency Indicators
Protocol Registration
Available
Data Sharing
Not Available
Code Sharing
Not Available
Overall Transparency Score:
High Transparency - This study meets good transparency standards.
Conflicts & Funding
| Conflicts of Interest: | Declared: Financial |
| COI Institutions: | AbbVie, Almirall, Amgen, Arena, Avillion, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi, Samsung Bioepis, Sandoz Hexal AG, UCB Pharma Ltd |
| Funding Source: | Declared: Public, professional society, private |
| Funding Institutions: | This research was supported in part by the NIHR Manchester Biomedical Research Centre and the NIHR Newcastle Biomedical Research Centre. Dr Yiu was funded by an NIHR Academic Clinical Lectureship through The University of Manchester. Drs Griffiths and Warren were funded in part by grant MR/L011808/1 from the Medical Research Council. The study group British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) is coordinated by The University of Manchester and funded by the British Association of Dermatologists (BAD). The BAD receives income from AbbVie, Almirall, Amgen, Celgene, Janssen, LEO Pharma, Lilly, Novartis, Samsung Bioepis, Sandoz Hexal AG, and UCB Pharma Ltd for providing pharmacovigilance services. This income finances a separate contract between the BAD and The University of Manchester that coordinate BADBIR. BADBIR acknowledges the support of the NIHR through the clinical research networks and the contribution made by clinical research associates who continue to facilitate recruitment into the registry. |