ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018 ACR/ARHP Annual Meeting
    • 2017-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • Meeting Resource Center

Abstract Number: 1638

Early Response As a Predictor of Long-Term Remission in DMARD-Naïve Patients with Severe, Active and Progressive Rheumatoid Arthritis Treated with Certolizumab Pegol in Combination with Methotrexate

Michael Weinblatt1, Clifton Bingham2, Gerd Burmester3, VP Bykerk4, Daniel E. Furst5, Xavier Mariette6, Désirée van der Heijde7, Daljit Tatla8, Catherine Arendt9, Irina Mountian10, Brenda VanLunen11 and Paul Emery12, 1Rheumatology Immunology & Allergy, Brigham and Women's Hospital, Boston, MA, 2Johns Hopkins University, Baltimore, MD, 3Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany, 4Hospital for Special Surgery, New York, NY, 5Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, 6Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, Paris, France, 7University Hospital, Maastricht, Netherlands, 88010 Arco Corporate Dr, UCB Pharma, Raleigh, NC, 9Global Medical Affairs, UCB Pharma, Brussels, Belgium, 10UCB Pharma, Brussels, Belgium, 11UCB Pharma, Raleigh, NC, 12Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: anti-TNF therapy, certolizumab pegol and rheumatoid arthritis (RA), Early Rheumatoid Arthritis

  • Tweet
  • Email
  • Print
Session Information

Date: Monday, November 9, 2015

Session Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:

In established rheumatoid arthritis (RA), a lack of response to
treatment with certolizumab pegol
(CZP) at early timepoints is associated with a low probability
of achieving future target responses.1 The phase 3 C-EARLY study
(NCT01519791) assessed efficacy and safety of CZP in inducing and maintaining a
sustained clinical response and inhibiting radiographic damage in DMARD-naïve
patients (pts) with active, severe, progressive RA with poor prognostic factors
in comparison to MTX alone. Here, we examine the association between response
to CZP+MTX in this pt population at an early visit
(improvement/lack of improvement from baseline [BL] in DAS28[ESR]
at Week [Wk] 12) and remission at Wk52.

Methods:

This
multicenter, double-blind, randomized study enrolled
pts who were DMARD-naïve with active, severe, progressive RA (<1 year since
diagnosis at BL, fulfilling 2010 ACR/EULAR criteria: ≥4 swollen and ≥4
tender joints; DAS28[ESR]≥3.2; CRP≥10 mg/L
and/or ESR≥ 28 mm/hr, rheumatoid factor/ACPA positive). 879 pts were
randomized 3:1 to CZP (400 mg at Wks 0, 2 and 4, then
200 mg every 2 wks to Wk52+MTX; n=660) or PBO+MTX Q2W
(n=219). MTX was initiated at 10 mg/wk and increased
to 25 mg/wk by Wk8, maximum tolerated dose per
patient (optimized dose) was maintained to Wk52. Predictability analyses
consisted of positive predictive value (PPV; probability of achieving Wk52
remission after achieving a Wk12 response) and negative predictive value (NPV;
probability of failing to achieve Wk52 remission after failing to achieve a
Wk12 response). Remission was defined as DAS28(ESR)<2.6;
Wk12 responses analyzed were change from BL in
DAS28(ESR) ≥0.6 and ≥1.2. Observed data were utilized for Wk12
responses; missing Wk52 values were imputed using non-responder imputation.

Results:

At
Wk52, 42.6% CZP+MTX pts vs 26.8% PBO+MTX pts achieved remission (DAS28[ESR]
<2.6) (Table A). NPV of early responses was high (Table B): CZP+MTX-treated
pts who did not achieve DAS28(ESR) improvements from BL ≥0.6 or ≥1.2
points at Wk12 had a high probability of not being in remission at Wk52; 92%
and 93% respectively. Pts who did achieve an improvement from BL in DAS28(ESR) of ≥0.6 and ≥1.2 at Wk12 had 45% and
49% chance of Wk52 remission (Table B), respectively.

Conclusion:

DMARD-naïve
pts with active, severe and progressive RA who failed to achieve DAS28(ESR) improvements at Wk12 after treatment with CZP+MTX
were unlikely to be in remission at Wk52. These findings in DMARD-naïve pts are
consistent with earlier reports in pts with established disease.

References:

1.    
van der Heijde D. J Rheumatol
2012; 39:1326-33


Disclosure: M. Weinblatt, Bristol-Myers Squibb, Genentech, Biogen IDEC Inc, GlaxoSmithKline, Human Genome Sciences Inc, MedImmune, Novo Nordisk, UCB Pharma, 2; C. Bingham, UCB Pharma, 5; G. Burmester, Abbvie, MSD, Pfizer, Roche, UCB Pharma, 5; V. Bykerk, None; D. E. Furst, Gilead, 2,GlaxoSmithKline, 2,NIH, 2,Novartis Pharmaceutical Corporation, 2,Pfizer Inc, 2,Roche Pharmaceuticals, 2,Genentech and Biogen IDEC Inc., 2,UCB, 2,Abbvie, 5,Actelion Pharmaceuticals US, 5,Amgen, 5,Bristol-Myers Squibb, 5,Cytori, 5,Janssen Pharmaceutica Product, L.P., 5,Gilead, 5,GlaxoSmithKline, 5,NIH, 5,Novartis Pharmaceutical Corporation, 5,Pfizer Inc, 5,Roche Pharmaceuticals, 5,Genentech and Biogen IDEC Inc., 5,UCB, 5,Abbvie, 8,Actelion Pharmaceuticals US, 8,Bristol-Myers Squibb, 2,Amgen, 2,Actelion Pharmaceuticals US, 2,Abbvie, 2,UCB, 8; X. Mariette, Pfizer, Roche, 2,Bristol-Myers Squibb, GlaxoSmithKline, Pfizer, Roche, UCB Pharma, 5; D. van der Heijde, Abbvie, Amgen, AstraZeneca, Augurex, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GlaxoSmithKline, Janssen, Merck, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB Pharma, Vertex, 5,Abbvie, Amgen, AstraZeneca, Augurex, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GlaxoSmithKline, Janssen, Merck, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB Pharma, Vertex, 2; D. Tatla, UCB Pharma, 3; C. Arendt, UCB Pharma, 3; I. Mountian, UCB Pharma, 3; B. VanLunen, UCB Pharma, 3; P. Emery, Pfizer, MSD, AbbVie, UCB Pharma, Roche, Bristol-Myers Squibb, 5.

To cite this abstract in AMA style:

Weinblatt M, Bingham C, Burmester G, Bykerk V, Furst DE, Mariette X, van der Heijde D, Tatla D, Arendt C, Mountian I, VanLunen B, Emery P. Early Response As a Predictor of Long-Term Remission in DMARD-Naïve Patients with Severe, Active and Progressive Rheumatoid Arthritis Treated with Certolizumab Pegol in Combination with Methotrexate [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/early-response-as-a-predictor-of-long-term-remission-in-dmard-naive-patients-with-severe-active-and-progressive-rheumatoid-arthritis-treated-with-certolizumab-pegol-in-combination-with-methotrexate/. Accessed May 27, 2023.
  • Tweet
  • Email
  • Print

« Back to 2015 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/early-response-as-a-predictor-of-long-term-remission-in-dmard-naive-patients-with-severe-active-and-progressive-rheumatoid-arthritis-treated-with-certolizumab-pegol-in-combination-with-methotrexate/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

© COPYRIGHT 2023 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

  • Home
  • Meetings Archive
  • Advanced Search
  • Meeting Resource Center
  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences