Certolizumab Pegol Plasma Concentrations and Endoscopic and Clinical Outcomes in Crohnʼs Disease: A Post Hoc Analysis of the MUSIC Trial: Presidential Poster

2012 ◽  
Vol 107 ◽  
pp. S674-S675 ◽  
Author(s):  
William Sandborn ◽  
Jean-Frederic Colombel ◽  
Matthieu Allez ◽  
Jean-Louis Dupas ◽  
Olivier Dewit ◽  
...  
2020 ◽  
Vol 16 (10) ◽  
pp. 833-841
Author(s):  
Nicolas M. Van Mieghem ◽  
Michael J. Reardon ◽  
Steven J. Yakubov ◽  
John Heiser ◽  
William Merhi ◽  
...  

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16529-e16529
Author(s):  
Dominic Pilon ◽  
Ajay S. Behl ◽  
Rhiannon Kamstra, ◽  
Yongling Xiao ◽  
Marie-Helene Lafeuille ◽  
...  

e16529 Background: A post-hoc analysis of COU-AA-302 trial data showed that brief pain inventory (BPI), lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and bone metastases were predictors for overall survival in men with mCRPC treated with AA+P. This study aimed to identify baseline predictors of other clinical outcomes. Methods: COU-AA-302 trial data were used to develop predictive models for prostate-specific antigen (PSA) progression, Eastern Cooperative Oncology Group performance status (ECOG PS) deterioration, and opiate use. Associations between baseline factors and outcomes were first assessed using multivariable Cox models among AA+P patients (Step 1). In Step 2, interaction testing was conducted between treatment (AA+P vs. placebo) and each potential predictor (P < 0.2) identified in Step 1. Final Cox models included predictors and any significant interactions (p < 0.05). Results: A total of 1,034 men (525 AA+P; 509 placebo) were included in the analysis. Baseline BPI, PSA, LDH, and ALP were predictors of PSA progression and opiate use regardless of AA+P or placebo with higher values indicating higher risks (all P < 0.05). Younger age, shorter time from luteinizing hormone-releasing hormone to randomization, higher Gleason score, and lower PSA at diagnosis were also associated with higher risks of opiate use: (all P < 0.05). For ECOG PS deterioration, higher baseline BPI, PSA, LDH, and Gleason score, older age, and lower baseline ECOG were associated with higher risks regardless of AA+P or placebo (all P < 0.05). Baseline ALP and site of metastasis also predicted ECOG PS deterioration but the effect varied by treatment (lower risk in AA+P versus placebo; both interactions’ P < 0.05). Conclusions: Predictors of PSA progression, ECOG PS deterioration, and opiate use were identified in AA+P and placebo-treated men with mCRPC. No predictors were associated with worse outcomes for AA+P versus placebo, while the negative impact of certain predictors on ECOG PS was favorably modified by AA+P. Further study is needed on the relationship between AA+P and prognostic factors.


2019 ◽  
Vol 126 (2) ◽  
pp. S141
Author(s):  
Gere Sunder-Plassmann ◽  
Ana Jovanovic ◽  
Ulla Feldt-Rasmussen ◽  
Vipul Jain ◽  
Markus Peceny ◽  
...  

2012 ◽  
Vol 39 (7) ◽  
pp. 1326-1333 ◽  
Author(s):  
DÉSIRÉE VAN DER HEIJDE ◽  
EDWARD C. KEYSTONE ◽  
JEFFREY R. CURTIS ◽  
ROBERT B. LANDEWÉ ◽  
MICHAEL H. SCHIFF ◽  
...  

Objective.To determine the relationship between timing and magnitude of Disease Activity Score [DAS28(ESR)] nonresponse (DAS28 improvement thresholds not reached) during the first 12 weeks of treatment with certolizumab pegol (CZP) plus methotrexate, and the likelihood of achieving low disease activity (LDA) at 1 year in patients with rheumatoid arthritis.Methods.In a post-hoc analysis of the RAPID 1 study, patients achieving LDA [DAS28(ESR) ≤ 3.2] at Year 1 were assessed according to DAS28 nonresponse at various timepoints within the first 12 weeks.Results.Seven-hundred eighty-three patients were included (CZP 200 mg, n = 393; CZP 400 mg, n = 390). A total of 86.9% of patients in the CZP 200 mg group had a DAS28 improvement of ≥ 1.2 by Week 12. Of the 13.1% of patients with DAS28 improvement < 1.2 by Week 12, only 2.0% had LDA at Year 1. Failure to achieve LDA at Year 1 depended on timing of nonresponse — 22.3%, 8.4%, and 2.0% of patients with DAS28 improvement < 1.2 by Weeks 1, 6, and 12, respectively, had LDA at Year 1 — and magnitude of initial lack of DAS28 improvement; for example, compared with the patients with DAS28 < 1.2 improvement, fewer patients with DAS28 < 0.6 had LDA at Year 1 (17.4%, 2.4%, and 0.0% at Weeks 1, 6, and 12, respectively).Conclusion.Failure to achieve improvement in DAS28 within the first 12 weeks of therapy was predictive of a low probability of achieving LDA at Year 1. Moreover, the accuracy of the prediction was found to be strongly dependent on the magnitude and timing of the lack of the response. (Clinical Trial Registration Nos. NCT00152386 and NCT00175877).


2011 ◽  
Vol 38 (6) ◽  
pp. 990-996 ◽  
Author(s):  
EDWARD C. KEYSTONE ◽  
JEFFREY R. CURTIS ◽  
ROY M. FLEISCHMANN ◽  
DANIEL E. FURST ◽  
DINESH KHANNA ◽  
...  

Objective.To assess the kinetics of response to certolizumab pegol (CZP), and association between rapid response and longterm outcomes, in patients with active rheumatoid arthritis (RA).Methods.This was a post-hoc analysis of the randomized, double-blind RAPID 1 study in patients who received methotrexate (MTX) and either CZP 200 mg subcutaneously or placebo every 2 weeks for 52 weeks. Clinical and radiographic outcomes at Week 52 were evaluated based on the Disease Activity Score 28 (DAS28) ≥ 1.2 and American College of Rheumatology 20% (ACR20) responses at Week 6 and Week 12.Results.Clinical responses [European League Against Rheumatism (EULAR), DAS28 ≥ 1.2, and ACR20 responses] were rapid in CZP-treated patients. Week 12 DAS28 ≥ 1.2 responders had better clinical and radiographic outcomes at Week 52 compared with nonresponders. Among Week 12 responders, incremental benefit of earlier response was observed: Week 6 DAS28 ≥ 1.2 responders and ACR20 responders had significantly higher ACR response rates and were more likely to achieve remission at Week 52 than Week 12 responders. Patients with a clinical response at Week 6 had faster, more meaningful sustained improvements in patient-derived outcomes than those responding by Week 12 only.Conclusion.Rapid attainment of clinical response in patients with RA is associated with improved longterm outcomes. Analysis of the kinetics of response to CZP during the first 12 weeks of therapy potentially permits informed prediction of clinical success or need to alter treatment. In patients not achieving a clinical response at Week 12 treatment adjustment should be considered. Trial registration NCT00152386.


2018 ◽  
Vol 54 (3) ◽  
pp. 140-148 ◽  
Author(s):  
Antonio Anzueto ◽  
Peter M.A. Calverley ◽  
Achim Mueller ◽  
Norbert Metzdorf ◽  
Michaela Haensel ◽  
...  

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