Day Four Poster Session Roundup: Part 2

Dozens of posters were presented under the RA umbrella during the morning of day 4 at the American College of Rheumatology/Association of Rheumatology Health Professionals 2009 Annual Scientific Sessions. Among the highlights were the following:

Certolizumab Pegol (CZP) Added to Methotrexate (MTX) Provides Lasting Improvements in Patient-Reported Outcomes (PROs) Over 2 Years

Authors: Strand B, Fleischmann R, Kvien TK, et al.

Purpose: "CZP 200 or 400 mg Q2W+MTX provided rapid, sustained, and clinically meaningful improvements in physical function and HRQoL, as well as reductions in arthritis pain and fatigue over 1 year (RAPID 1 trial). Here we present the impact of CZP+MTX on these PROs over 2 years."

Results: Researchers reported that "clinically-meaningful improvements in physical function and reductions in pain and fatigue were reported at Wk 1 with CZP; HRQoL improvements were reported at Wk 12 (first post-BL assessment). Improvements in all PROs were sustained through at least Wk 100 (Table). At Wk 100, physical function (HAQ-DI) was improved on average by 0.79 points for completers originally treated with CZP 200 mg+MTX; pain relief averaged 39.5 points, and fatigue relief averaged 3.2 points. Patients originally receiving CZP 200 mg+MTX had mean improvements of 10.1 and 7.7 points for the PCS and MCS, respectively (Wk 100). HRQoL levels approached US population norms in the Vitality and Mental Health domains. Comparable benefits were observed in completers who received CZP 400 mg+MTX in RAPID 1."

Open-Label Certolizumab Pegol Is Effective in Patients Who Withdrew From Double-Blind Treatment Due to Non-Response

Authors: Keystone EC, van der Heijde D, Smolen JS, et al.

Purpose: To present "the efficacy of open-label (OL) CZP + MTX in patients who withdrew from double-blind treatment with either CZP or PBO."

Results: This study found that "a subset of patients with ongoing active disease that failed to respond to CZP or PBO in the double-blind phase rapidly responded to CZP upon receiving OL therapy." These data suggest that "response to CZP + MTX, and perhaps other study drugs, may be underestimated in a double-blind trial, and supports the use of an early escape to OL treatment in clinical trials," and researchers noted that these results "may also contribute to the understanding as to how both patient and physician perceptions are influenced by the possibility of receiving placebo versus active treatment."

Safety Update On Certolizumab Pegol (CZP) in Patients with Active Rheumatoid Arthritis (RA)

Authors: van Vollenhoven RF, Smolen JS, Schiff M, et al.

Purpose: To "update the safety profile of CZP in RA clinical trials and open-label extensions (OLEs)."

Results: Results of this study indicated that "the incidence rate of AEs and SAEs and the overall safety profile of CZP remained similar to previous reports with the addition of 850 pt-yrs of CZP exposure." Researchers also noted that "these data support the favorable benefit/risk balance for CZP in RA."

The Efficacy of Certolizumab Pegol Added to Methotrexate Is Sustained Over 2 Years in the Treatment of Rheumatoid Arthritis

Authors: Keystone EC, Smolen JS, Landewé R, et al.

Purpose: To present "the efficacy of CZP + MTX over 2 years."

Results: Researchers found that "CZP + MTX provided sustained, long-term inhibition of the progression of radiographic joint damage and improvements in RA signs and symptoms, with no new safety signals, over 2 years."

Incremental Benefit of Open-Label Certolizumab Pegol + MTX in Rheumatoid Arthritis (RA) Patients Following Double-Blind Placebo + MTX Treatment out to 2 Years

Authors: Combe B, Schwartzman S, Massarotti B, et al.

Purpose: The purpose of this presentation was to present "on efficacy outcomes in subjects who completed 1 year of PBO + MTX followed by 1 year of OL CZP + MTX for a total of 2 years' treatment."

Results: According to the authors, "radiographic disease progression slowed upon initiation of OL CZP + MTX in subjects who completed 52 wks of double-blind treatment with PBO + MTX," and "these subjects also experienced sustained improvements in the signs and symptoms of RA throughout 2 years, including marked improvements in DAS28 and HAQ-DI scores upon switching to OL CZP treatment."

Rapid Prediction of Low Disease Activity at 1 Year Among RA Patients Treated with Certolizumab Pegol

Authors: Curtis JR, Luijtens B

Purpose: The objective of this analysis was to "determine the prognostic significance of data collected early after starting certolizumab pegol (CZP) to predict low disease activity (LDA) at 1 year."

Results: Using CART, researchers "accurately classified ~75% of RA pts as early responders/non-responders within 12 wks of initiating CZP," and "Wk 28 data improved predictability by an additional 10%." The study authors noted that "classification trees may be useful to prospectively guide the management of individual RA pts treated with CZP and perhaps other biologic therapies."