Constarium
← Search

Data · collection · 2015

RENACER study: Assessment of 12-month efficacy and safety of 168 certolizumab PEGol rheumatoid arthritis-treated patients from a Spanish multicenter national database

Listed in DataCite

Objective : To assess effectiveness and safety of certolizumab PEGol (CZP) in rheumatoid arthritis (RA) patients after 12 months of treatment and to detect predictors of response.

Description

Methods

Observational longitudinal prospective study of RA patients from 35 sites in Spain. Variables (baseline, 3- and 12-month assessment): sociodemographics, previous Disease Modifying Anti-Rheumatic Drug (DMARD) and previous Biological Therapies (BT) use; TJC, SJC, ESR, CRP, DAS28, SDAI. Response variables: TJC, SJC, CRP, ESR, and steroids dose reductions, EULAR Moderate/Good Response, SDAI response and remission, DAS28 remission.

Read the rest (3 more)

Safety variables: discontinuation due to side-effects. Descriptive, comparative and Logistic regression analyses were performed. Results : We included 168 patients: 79.2% women, mean age 54.5 years (±13.2 SD), mean disease duration 7.5 years (±7.3 SD).

Mean number of prior DMARD: 1.4 (±1.2 SD), mean number of prior BT was 0.8 (±1.1). Mean time on CZP was 9.8 months (±3.4 SD). A total of 71.4% were receiving CZP at 12-month assessment.

Baseline predictors of response: lower prior number DMARD; low number prior BT; higher CRP, ESR, TJC, SJC, DAS28 and SDAI ( p Conclusions : CZP showed benefit in severe RA patients, with significant reduction of all effectiveness parameters, despite the high prevalence of previous BT exposure in our series. We found CRP, ESR, prior DMARD/BT number, TJC, SJC, DAS28, and SDAI as baseline predictors of response. CZP was mostly well tolerated.

Links

Topics

From keywords
Medicine & Health
Inferred from text
Disease 75% · Longitudinal study 65%

Related

Provenance · 1 source records, 12 field assertions
SourceKeyLast seenRaw
DataCite10.6084/m9.figshare.c.211114413 d agoJSON v1
FieldAssertionExtractorEvidence
access_levelsource · DataCiteconnector:datacite@1.0.0/data/attributes/rightsList
concepts[disease].local:disease:diseaseenrichment · DataCitekeyword-concept-rules@1.0.0title+description (75%)
concepts[field].fos:biological-sciencessource · DataCiteconnector:datacite@1.0.0
concepts[field].fos:clinical-medicinesource · DataCiteconnector:datacite@1.0.0
concepts[field].local:field:medicine-healthmapping · DataCitevocabulary-mapper@1.0.0keywords['Medicine']
concepts[method].local:method:longitudinal-studyenrichment · DataCitekeyword-concept-rules@1.0.0title+description (65%)
created_datesource · DataCiteconnector:datacite@1.0.0
descriptionsource · DataCiteconnector:datacite@1.0.0/data/attributes/descriptions
licensesource · DataCiteconnector:datacite@1.0.0/data/attributes/rightsList
publication_datesource · DataCiteconnector:datacite@1.0.0/data/attributes/dates
titlesource · DataCiteconnector:datacite@1.0.0/data/attributes/titles/0/title
updated_datesource · DataCiteconnector:datacite@1.0.0