Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose:
Previous reports of RAPID-axSpA have demonstrated the efficacy and safety of certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, in patients (pts) with axial spondyloarthritis (axSpA) including pts with ankylosing spondylitis (AS, meeting modified New York criteria) and pts with no sacroiliitis on X-ray (non-radiographic axSpA, nr-axSpA), to Week (Wk) 24.1 We report clinical efficacy and safety of CZP in axSpA pts to Wk48.
Methods:
The ongoing RAPID-axSpA trial (NCT01087762) is double-blind and placebo (PBO) controlled to Wk24 and dose-blind to Wk48.1 Pts fulfilled ASAS criteria2 and had active axSpA, including both AS pts and nr-axSpA pts. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued on their assigned dose in dose-blind phase; PBO pts entering dose-blind phase were re-randomized to CZP loading dose followed by CZP 200mg Q2W or CZP 400mg Q4W after Wk24 or, for non-responders Wk16. We present efficacy data for all pts originally randomized to CZP and imaging outcomes for all pts included in the imaging sub-study (MRI set). Endpoints included ASAS20 and ASAS40 responses, ASAS PR and ASDAS outcomes. Also included were BASDAI, BASFI, BASMI-linear, total spine pain, fatigue, ASQoL, SPARCC and ASspiMRI-a. Outcomes are presented at Wk24 and Wk48. NRI was used for categorical measures and LOCF for quantitative measures. Safety sets consists of all pts treated with CZP at any stage of the 48-wk trial.
Results:
325 pts were randomized, of which 218 received CZP from Wk0. Of pts randomized to CZP at baseline (BL), 93% completed Wk24 and 88% Wk48. ASAS20, ASAS40 and ASAS PR were maintained from Wk24 to 48 (Table) and improvements from BL in BASDAI, BASFI, BASMI-linear, ASDAS and ASDAS-ID were also maintained to Wk48 (Table). Reductions in pain, fatigue and ASQoL were also observed between Wk24 and Wk48 (Table). In the MRI sub-study (CZP N=104), reduction of inflammation, as measured by SPARCC and ASspiMRI-a, was maintained to Wk48. Similar improvements were seen with both dosing regimens and in both AS and nr-axSpA subpopulations (Table). In the safety set (N=315), adverse events (AEs) occurred in 248 pts (78.7%; event rate per 100 pt-yrs=419.5), serious AEs in 25 (7.9%). Serious infections occurred in 10 (3.2%) pts, including suspected tuberculosis in 3 (1.0%) of which 1 was confirmed (from Mexico). No deaths or malignancies were reported.
Conclusion:
In the RAPID-axSpA trial, improvements observed over 24 wks in clinical efficacy, patient-reported and MRI outcomes were sustained over 48 wks in both CZP dosing regimens. Similar sustained improvements in clinical, patient-reported and MRI outcomes were observed in both AS and nr-axSpA subpopulations. The safety profile was in line with that observed for CZP in RA.
References:
1. Landewe R. Arthritis Rheum 2012;64(10):336-337, 2. Rudwaleit M. Ann Rheum Dis 2009;68(6):770-776.
Disclosure:
R. B. M. Landewé,
Abbott, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Centocor, Glaxo-Smith-Kline, 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;
M. Rudwaleit,
Abbott, BMS, MSD, Pfizer, Roche, UCB Pharma,
5;
D. M. 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, Vertex ,
5,
Imaging Rheumatology bv,
9;
M. Dougados,
UCB Pharma,
2,
UCB Pharma,
5;
P. 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;
J. D. Reveille,
UCB Pharma and Abbott,
5;
J. Walsh,
Abbott, Celgene and UCB,
5;
A. J. Kivitz,
Abbott, Pfizer, Merck, Janssen, Novartis, Celgene, UCB,
2,
Abbott, Pfizer, Janssen, Celgene, UCB,
5;
W. P. Maksymowych,
Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc and UCB Pharma,
2,
Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc and UCB Pharma,
5,
Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc and UCB Pharma,
8;
J. Braun,
Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma,
2,
Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma,
5;
A. A. Deodhar,
UCB Pharma, Abbott, Amgen, Janssen, Novartis,
2,
UCB Pharma, Abbott, Amgen, Janssen, Novartis,
5,
Abbott, Pfizer, UCB Pharma,
9;
C. Stach,
UCB Pharma,
3;
B. Hoepken,
UCB Pharma,
3;
P. Singh,
UCB Pharma,
3;
J. Sieper,
Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen,
5,
Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen,
8.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/effect-of-certolizumab-pegol-over-48-weeks-in-patients-with-axial-spondyloarthritis-including-ankylosing-spondylitis-and-non-radiographic-axial-spondyloarthritis/