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

Torrente-Segarra, Vicenç; Arana, A.; Fernández, Amalia Sanchez-Andrade; Beltrán, J.V. Tovar; Jiménez, A. Muñoz; Martínez-Cristόbal, A; Ferrández, José Antonio González; Prada, Manuel Fernández; Fuentes, Noelia Vázquez; Corominas, Hèctor; García-Díaz, Silvia; Pereira, Asunción Acosta; Martín, José M.; Riazuelo, José Ramón Lamua; Moliner, Rosa Expósito; Vilchez, Desireé Ruiz; Cabello, Raúl Veiga; Fernández, Jesús C; Pons, José Raúl Noguera; Puñal, Noemí Patricia Garrido; Celiméndiz, Pedro Giralt; Verdu, R; Díez, Angel Aragón; Roura, Carlos Tomás; Turudi, Concepción Moll; Torrent, Delia Taverner; Santirso, Felipe Joaquín Rivas; Garrido, Juan Jóse Lerma; Portales, Rosa García; Palau, Sergi Ordoñez; González-Albo, Silvia Paredes; Pérez, Antonio Gracia; Mateos, Arantxa Conesa; Alén, Jaime Calvo; Gil, Jenaro Graña; Alonso, María Pilar Navarro; Blasco, María Jesús Martínez; StudyGroup, RENACER

doi:10.3109/14397595.2015.1101200

Cited by 13 publications

(11 citation statements)

References 31 publications

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“…The same study also demonstrated that longer disease duration and prior use of biologic DMARDs (TNFi), but not csDMARDs, was associated with significantly reduced likelihood of achieving sustained remission 18. Association between higher number of prior DMARDs and reduced likelihood of achieving treatment response has been demonstrated in a few other RA studies,14 19 20 including two certolizumab pegol studies 13 21. In our study, a greater number of prior DMARDs and longer disease duration were associated with significantly decreased odds of achieving improvement as measured by ACR response.…”

Section: Discussionsupporting

confidence: 74%

Effect of disease duration and prior disease-modifying antirheumatic drug use on treatment outcomes in patients with rheumatoid arthritis

et al. 2019

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ObjectivesTo determine if disease duration and number of prior disease-modifying antirheumatic drugs (DMARDs) affect response to therapy in patients with established rheumatoid arthritis (RA).MethodsAssociations between disease duration or number of prior DMARDs and response to therapy were assessed using data from two randomised controlled trials in patients with established RA (mean duration, 11 years) receiving adalimumab+methotrexate. Response to therapy was assessed at week 24 using disease activity outcomes, including 28-joint Disease Activity Score based on C-reactive protein (DAS28(CRP)), Simplified Disease Activity Index (SDAI) and Health Assessment Questionnaire Disability Index (HAQ-DI), and proportions of patients with 20%/50%/70% improvement in American College of Rheumatology (ACR) responses.ResultsIn the larger study (N=207), a greater number of prior DMARDs (>2 vs 0–1) was associated with smaller improvements in DAS28(CRP) (–1.8 vs –2.2), SDAI (–22.1 vs –26.9) and HAQ-DI (–0.43 vs –0.64) from baseline to week 24. RA duration of >10 years versus <1 year was associated with higher HAQ-DI scores (1.1 vs 0.7) at week 24, but results on DAS28(CRP) and SDAI were mixed. A greater number of prior DMARDs and longer RA duration were associated with lower ACR response rates at week 24. Data from the second trial (N=67) generally confirmed these findings.ConclusionsNumber of prior DMARDs and disease duration affect responses to therapy in patients with established RA. Furthermore, number of prior DMARDs, regardless of disease duration, has a limiting effect on the potential response to adalimumab therapy.

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Section: Discussionsupporting

confidence: 74%

Effect of disease duration and prior disease-modifying antirheumatic drug use on treatment outcomes in patients with rheumatoid arthritis

et al. 2019

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“…Other real-world studies of certolizumab in RA patients have also found significant improvements. Two of them were registry-based studies in Sweden [ 26 ] and Italy [ 27 ] and the third was a Spanish observational multicenter study [ 28 ]. Study designs were different and EULAR response was evaluated at 6 months [ 26 , 27 ] and/or 1 year [ 27 , 28 ].…”

Section: Discussionmentioning

confidence: 99%

“…Two of them were registry-based studies in Sweden [ 26 ] and Italy [ 27 ] and the third was a Spanish observational multicenter study [ 28 ]. Study designs were different and EULAR response was evaluated at 6 months [ 26 , 27 ] and/or 1 year [ 27 , 28 ]. Although certolizumab was effective and safe in all these studies, percentages of good response were different: 38 [ 26 ] and 65% [ 27 ] of patients at 6 months and 66 [ 27 ] and 46.4% [ 28 ] of patients at 12 months.…”

Section: Discussionmentioning

confidence: 99%

Certolizumab Pegol in a Heterogeneous Population of Patients with Moderate-To-Severe Rheumatoid Arthritis

Soriano

Dellepiane

Salvatierra³

et al. 2018

Future Sci. OA

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Aim:To determine the efficacy and safety of certolizumab pegol for the treatment of rheumatoid arthritis in a real-world setting.Materials & methods:Patients with moderate-to-severe rheumatoid arthritis who initiated therapy with certolizumab were followed for 12 weeks. Response was assessed with Disease Activity Score of 28 joints, European Ligue Against Rheumatism criteria and Simplified Disease Activity Index. Predictors of response were analyzed with binary logistic regression models.Results:Statistically significant decreases in tender and swollen joint counts, laboratory parameters and use of corticosteroids and disease-modifying antirheumatic drugs were found. Disease activity also significantly diminished. Higher Disease Activity Score of 28 joints at baseline was the main predictor of response. No severe adverse events were reported.Conclusion:Certolizumab was effective and well tolerated, particularly in the subpopulation with higher inflammatory burden at baseline.

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“…Some ‘real world’ studies have reported better outcomes than these meta‐analyses, with remission rates or remission/low disease activity (as defined by DAS28 score) as high as 44–63% 18,19 . In the British Society for Rheumatology (BSR) Biologics Registry for Rheumatoid Arthritis, remission (DAS28 <2.6) was achieved in about 15% and low disease activity (DAS28 2.6 to 3.2) in about 26% of patients treated with anti‐TNF therapy between 2001 and 2013 20 .…”

Section: Range Of Biological Therapies For Rheumatoid Arthritismentioning

confidence: 97%

Biological disease‐modifying drugs for rheumatoid arthritis

Chaplin¹

2020

Prescriber

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

Cited by 13 publications

References 31 publications

Effect of disease duration and prior disease-modifying antirheumatic drug use on treatment outcomes in patients with rheumatoid arthritis

Effect of disease duration and prior disease-modifying antirheumatic drug use on treatment outcomes in patients with rheumatoid arthritis

Certolizumab Pegol in a Heterogeneous Population of Patients with Moderate-To-Severe Rheumatoid Arthritis

Biological disease‐modifying drugs for rheumatoid arthritis

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