Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose:
In the RAPID1 randomized controlled trial (RCT; NCT00152386),1 certolizumab pegol (CZP) every 2 weeks (Q2W) plus MTX over 52 weeks (wks) provided rapid improvements in signs and symptoms and inhibition of radiographic damage in patients (pts) with active rheumatoid arthritis (RA). In this publication we examine the safety and efficacy of CZP plus MTX over 5 yrs in RA.
Methods:
Eligible pts were treated in the open-label extension (OLE) to RAPID1 (NCT00175877) with CZP 400mg Q2W, reduced to 200mg Q2W after ≥6 months, plus MTX.2 Primary objective of the OLE was to monitor safety; secondary objective was to assess efficacy. Combined safety data from RCT and OLE are presented to Wk334 (6.4 yrs) for all pts receiving ≥1 dose of CZP in RCT or OLE (Safety population, N=958). ACR20/50/70, DAS28(ESR) and HAQ-DI are reported to Wk256 (4.9 yrs) for CZP pts who completed the 52-wk RCT (CZP Completers, N=508) and for all pts randomized to CZP 400mg or 200mg in RCT (ITT population, N=783). Change from baseline in modified Total Sharp Score (mTSS) and % of pts with radiographic non-progression (defined as a change in mTSS from RCT baseline of ≤0.5) are reported to Wk148 (2.8 yrs) for CZP Completers. Missing categorical data were imputed by modified non-responder imputation, continuous data by last observation carried forward, and radiographic data by linear extrapolation. Kaplan-Meier analysis was used to estimate pt retention.
Results:
Overall event rate per 100 pt-yrs (ER) of AEs was 290.4 and SAEs was 20.3 (serious infections=5.9; total exposure [including 84-day safety follow-up period]: 3,732 pt-yrs). The most common AEs (MedDRA preferred terms) were urinary tract infection (ER=7.9), nasopharyngitis (ER=7.3) and upper respiratory tract infection (ER=7.3). 177 pts (18.5%) experienced an AE leading to withdrawal (incidence rate per 100 pt-yrs [IR]=4.8). 21 (2.2%) experienced an AE leading to death (IR=0.6) (including 5 malignancies, 5 cardiac disorders, 3 infections). ACR20/50/70 response rates for CZP Completers and ITT population were maintained to Wk256 (74.4%/57.3%/39.6% and 59.0%/43.7%/28.8%, respectively), as were DAS28(ESR) remission rates (25.2% and 20.3%), improvements in DAS28(ESR) (mean values: 3.43 and 3.83; mean change from baseline: -3.49 and -3.08) and HAQ-DI (mean values: 0.90 and 1.00; mean change from baseline: -0.77 and -0.66). The rate of radiographic progression in CZP-treated pts was not observed to change over time (mean change in mTSS from RCT baseline to Wk52: 0.27, from RCT baseline to Wk148: 0.77; proportion of pts achieving radiographic non-progression at Wk52: 76.5%, Wk148: 68.9%).
Conclusion:
CZP plus MTX provided a favorable risk-benefit profile over 5 yrs of treatment in pts with active RA. No new safety signals were identified.
References:
1. Keystone E. Arthritis Rheum 2008;58(11):3319-3329; 2. Keystone E. Rheumatology 2012;51(9):1628-1638 
Disclosure:
E. Keystone,
Abbott, AstraZeneca, Biotest, BMS, F. Hoffmann-La Roche, Genentech, Janssen, Lilly, Merck, Nycomed, Pfizer, UCB Pharma ,
2,
Abbott, Amgen, AstraZeneca, BMS Canada, F. Hoffmann-La Roche, Janssen, Pfizer, UCB Pharma,
8;
R. Landewé,
Abbott, Ablynx, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Centocor, GlaxoSmithKline, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth,
5,
Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth ,
2,
Abbott, Amgen, Bristol-Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth,
8;
R. van Vollenhoven,
Abbvie, BMS, GSK, MSD, Pfizer, Roche, UCB Pharma,
2,
Abbott, BMS, GSK, Lilly, MSD, Pfizer, Roche, UCB Pharma,
5;
B. Combe,
Merck, Pfizer Inc, Roche-Chugai,
2,
Bristol-Myers Squibb, Celgene, Lilly, Merck Human Health, Novartis, Pfizer Inc, Roche-Chugai, UCB Pharma,
5,
Bristol-Myers Squibb, Celgene, Lilly, Merck, Novartis, Pfizer Inc, Roche-Chugai, UCB Pharma,
8;
V. Strand,
UCB Pharma,
5;
P. J. Mease,
AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, Vertex,
2,
AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, Vertex,
5,
AbbVie, Amgen, BiogenIdec, BMS, Crescendo, Genentech, Janssen, Lilly, Pfizer, UCB,
8;
L. Shaughnessy,
UCB Pharma,
3;
B. VanLunen,
UCB Pharma,
3;
D. van der Heijde,
AbbVie, Amgen, AstraZeneca, Augurex, BMS, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex,
5,
Director of Imaging Rheumatology BV,
4.
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