ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2321

Long-Term Safety and Efficacy Of Certolizumab Pegol In Combination With Methotrexate In The Treatment Of Rheumatoid Arthritis: 5-Year Results From a 24-Week Randomized Controlled Trial and Open-Label Extension Study

Josef S. Smolen1, Ronald van Vollenhoven2, Arthur Kavanaugh3, Vibeke Strand4, Jiri Vencovsky5, Michael H. Schiff6, Robert Landewé7, Boulos Haraoui8, Susan Walker9 and Désirée van der Heijde10, 1Medical University of Vienna and Hietzing Hospital, Vienna, Austria, 2Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska Institute, Stockholm, Sweden, 3Division of Rheumatology Allergy and Immunology, University of California San Diego, San Diego, CA, 4Adjunct, Division of Immunology / Rheumatology, Stanford University, Palo Alto, CA, 5Institute of Rheumatology, Department of Clinical and Experimental Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, 6Rheumatology Division, University of Colorado, Denver, CO, 7Academic Medical Center Amsterdam & Atrium Medical Center, Heerlen, Netherlands, 8Centre Hospitalier de l’Université de Montréal, Montreal, QC, Canada, 9UCB Pharma, Raleigh, NC, 10Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: , , , ,

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy III

Session Type: Abstract Submissions (ACR)

Background/Purpose:

In the RAPID2 randomized controlled trial (RCT; NCT00160602), certolizumab pegol (CZP) +MTX every 2 weeks (Q2W) improved signs and symptoms of rheumatoid arthritis (RA) over 24 weeks (wks).1 Previous results demonstrated long-term safety and efficacy of CZP+MTX over 3 yrs in RAPID2 open-label extension (OLE).2 We present the final report on long-term safety and efficacy of CZP+MTX over 5 yrs.

Methods:

Eligible patients (pts) from RAPID2 RCT were treated in OLE (NCT00160641) with CZP 400mg Q2W, reduced to 200mg Q2W after ≥6 months, +MTX. Combined safety data from RCT and OLE are reported for all pts treated with ≥1 dose of CZP (N=612). AEs and SAEs were assessed at each visit following first dose of CZP. DAS28(ESR), HAQ-DI and ACR20/50/70 are presented to Wk232 for CZP Completers (pts who completed RCT and enrolled onto OLE [N=342]) and CZP ITT population (all pts randomized to CZP in RCT [N=492]). Change from baseline in modified Total Sharp Score (mTSS) and % of pts with radiographic non-progression (mTSS change from RCT baseline ≤0.5) are reported to Wk128 for CZP Completers. Dose reduction efficacy data is presented for all Wk24 CZP Completers who received CZP 400mg Q2W +MTX for ≥6 months in OLE, following which the CZP dose was reduced to 200mg Q2W over 132 wks of CZP exposure. Modified non-responder imputation (mNRI) was used for ACR responses; LOCF for continuous efficacy measures; mTSS data imputed by linear extrapolation.

Results:

Of 492 pts treated with CZP+MTX, 355 (72%) completed the RCT and 342 entered OLE, of which 215 remained after 232 wks from RCT baseline. Safety profile was consistent with previous reports. Most frequent AEs (preferred terms) are reported (Table). 19 pts (3.1%) died (IR=0.82) (including 5 malignancies, 4 cardiac disorders, 4 nervous system disorders, 4 injuries). No new safety signals were identified. Clinical improvements from RCT were maintained to Wk232 in CZP Completers and ITT Population, respectively: mean DAS28(ESR), 3.7 and 3.9; mean HAQ-DI, 0.96 and 1.06; ACR20/50/70, 68.4%/47.1%/25.1% and 65.9%/45.4%/24.2%. Radiographic progression in CZP-treated pts was minimal (mean mTSS change from RCT baseline to Wk24: 0.62, from RCT baseline to Wk128: 0.79; % of pts with radiographic non-progression at Wk24: 84.6%, Wk128: 73.2%). Clinical improvements were maintained in the dose reduction population (400mg to 200mg Q2W +MTX; N=288) from the first CZP 200mg treatment (DAS28[ESR]=3.5) through 132 wks of CZP 200mg Q2W (DAS28[ESR]=3.6).

Conclusion:

In pts with active RA despite MTX, CZP+MTX maintained reduction in signs and symptoms of RA with a favorable long-term risk-benefit ratio.

References:

1.     Smolen J.S. Ann Rheum Dis 2009;68:797-804; 2. Smolen J.S. Arthritis Rheum 2010;62(Suppl10):1806.

Disclosure:

J. S. Smolen,

UCB Pharma,

2,

UCB Pharma,

5;

R. van Vollenhoven,

Abbvie, BMS, GSK, MSD, Pfizer, Roche, UCB Pharma,

2,

Abbott, BMS, GSK, Lilly, MSD, Pfizer, Roche, UCB Pharma,

5;

A. Kavanaugh,

Abbott, Amgen, BMS, Janssen, Pfizer, Roche, UCB Pharma,

2;

V. Strand,

UCB Pharma,

5;

J. Vencovsky,

Abbott, MSD, Pfizer, Roche, UCB Pharma,

5,

MSD, Pfizer, Roche, UCB Pharma,

8;

M. H. Schiff,

UCB Pharma,

5,

UCB Pharma,

2;

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;

B. Haraoui,

Abbott, Amgen, BMS, Janssen, Pfizer, Roche and UCB Pharma,

2,

Abbott, Amgen, BMS, Janssen, Pfizer, Roche and UCB Pharma,

8,

Abbott, Amgen, BMS, Janssen, Pfizer, Roche and UCB Pharma,

5;

S. Walker,

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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