Microsoft powerpoint - crx-139 acr 2007 poster_final km1 [read-only]

A Clinical Study of Very Low Dose Prednisolone and Paroxetine for Active Rheumatoid Arthritis
Edward Keystone1, Jude Rodrigues2, Jiri Vencovsky3, Carter Thorne4, Marco Matucci-Cernic5, Johannes Bijlsma6, Melissa Nichols7, Theresa Podrebarac7, Josef S. Smolen81University of Toronto, Canada; 2Clinical Research and Arthritis Center, Windsor, Canada; 3Institute of Rheumatology, Prague, Czech Republic; 4Arthritis Program Research Group, Newmarket, Canada; 5 University of Florence, Italy; 6University Medical Center Utrecht, The Netherlands; 7Combinatorx, Cambridge, MA; 8University of Vienna, Austria ACR Responses over time
Rheumatoid arthritis (RA) is the most common adult inflammatory EULAR Good Response and Remission
arthritis affecting approximately 1% of the worldwide population. Oralglucocorticoids are effective for the control of RA disease activity and Prednisolone
are disease-modifying. However, the use of chronic glucocorticoids is EULAR Good
limited by dose-dependent toxicities. CRx-139 is a novel combination Response
agent containing a very low dose of prednisolone and paroxetine.
Paroxetine, a selective serotonin reuptake inhibitor (SSRI), is thought to p=0.0314
selectively amplify the immunologic and anti-inflammatory benefits of glucocorticoids without potentiating their side effects. Previously, CRx-139 has been shown to reduce TNFα, IL-6 and C-reactive protein p=0.2529
To evaluate the activity of CRx-139 in reducing RA disease activity in
comparison to very low dose prednisolone in patients on DMARD Days 42 and 70
CRx-139-treated patients achieved ACR20 responses superior to prednisolone given alone. At Day 42, 55% of CRx-139High-treated versus 36% of prednisolone-treated METHODS
EULAR good response and remission in the CRx-139High group suggested a dose patients achieved an ACR20 response (p=0.026). 32% of CRx-139high-treated patients A 14-week, randomized, multi-center study was conducted in RA response. 19% of subjects in the CRx-139High group achieved remission at Day 42 achieved ACR50 response compared to 13% of the prednisolone-treated (p=0.008). patients (n= 209). Patients with at least 6 tender and 4 swollen joints and maintained that level of response to Day 70. CRx-139 activity could not be However, the effect was not maintained to Day 70 which was the primary endpoint.
remained on stable doses of DMARDs and NSAIDs. Oral glucocorticoids were discontinued at least 1 month prior. All patientsreceived 3 mg prednisolone as a split dose for 2 weeks. Patients were Median ACR Core Assessments
Adverse Events
n=140 (%)
CRx-139Low: prednisolone 3 mg plus paroxetine 10 mg (n=71) Baseline D42 D70 Baseline D42 D70
Baseline D42 D70
CRx-139High: prednisolone 3 mg plus paroxetine 20 mg (n=69) Infections
The primary efficacy endpoint in this study was to evaluate the Dizziness
proportion of ACR 20 responders from Baseline to the end of the CRx-139 was generally well tolerated. An equal number of serious adverse events treatment period (Day 70), after 56 days of combination treatment and occurred with prednisolone alone and CRx-139-treated patients.
14 days of prednisolone treatment using the intent to treat (ITT) Physician
population with a non-responder imputation (NRI) for missing values.
Secondary efficacy endpoints were to evaluate the difference in DAS28 response, CRP levels, and inflammatory cytokine levels between RA subjects treated with each of two doses of CRx-139 plus DMARD therapy and subjects treated with steroid plus DMARD therapy after 10 CRx-139High-treatment produced a clinically meaningful decrease in disease activity as demonstrated by the proportion of patients achieving ACR50, EULAR weeks of treatment in the ITT population with last observation carried good response and remission at Day 42. The patients who achieved remission forward (LOCF) for missing values unless otherwise noted.
CRx-139High-treated patients had an improvement in the median percent reduction had durability of the response to Day 70. Pain was sensitive to change with CRx- of pain (-49.38% vs.-23.44%; *p=0.0027) at Day 42 compared to prednisolone.
139 treatment. The activity of low dose glucocorticoid (3 mg/day) may be higher This effect was not durable to Day 70.
in this study given the split-dosing regimen and lack of a placebo group.
ACR 2007, Boston



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