ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 1647

A Randomized, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of Etoricoxib in Patients with Rheumatoid Arthritis

Kara Bickham1, Désirée van der Heijde2, Narinder Rawal3, Joachim Sieper4, Boyd Scott5, Nancy Frontera1, Sandhya Shah1, Paul Stryszak1, Dimitris Papanicolaou1, Zoran Popmihajlov1 and Paul Peloso1, 1Merck & Co., Inc., Kenilworth, NJ, 2University Hospital, Maastricht, Netherlands, 3Orebro University Hospital, Orebro, Sweden, 4Rheumatology, Charite - Campus Benjamin Franklin, Berlin, Germany, 5Merck Sharp & Dohme Corp., Whitehouse Station, NJ

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: clinical trials, COX inhibitors, rheumatoid arthritis (RA) and rheumatoid arthritis, treatment

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Date: Monday, November 9, 2015

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:

Etoricoxib, a selective
cyclooxygenase-2 (COX-2) inhibitor, provides symptom modification in RA
patients. Previous dose-ranging studies in RA demonstrated the clinical
efficacy of etoricoxib 90 mg vs placebo (PBO). In these studies, etoricoxib 60
mg demonstrated some clinically meaningful treatment effects, therefore the current
study further evaluated the efficacy of etoricoxib 60 mg and 90 mg in RA.

Methods:

This was a 2-part,
double-blind, PBO controlled study in RA. Part I (6 weeks) assessed the
efficacy of etoricoxib 60 mg and 90 mg vs PBO. Part II (6 weeks) evaluated
whether subjects with inadequate pain relief on etoricoxib 60 mg in Part I
benefitted from increasing to etoricoxib 90 mg in Part II.  Patients were ≥18
years of age, with a diagnosis of RA ≥6 months prior to screening and
prior clinical response to NSAIDs. Patients were required to have a disease
flare after NSAID washout prior to randomization. Eligible patients were
randomized to one of four treatment groups: PBO in Part I; etoricoxib 60 mg in
Part I & II; etoricoxib 60 mg in Part I followed by 90 mg in Part II; or etoricoxib
90 mg in Part I in a 2:7:7:8 ratio, respectively. Primary endpoints were
Disease Activity Score evaluating 28 joints and C reactive protein level
(DAS28-CRP) index and Patient Global Assessment of Pain (PGAP) score (0-100 mm
VAS) after 6 weeks of treatment in Part I. Safety
and tolerability measures included independent adjudication of all thrombotic
cardiovascular and serious upper GI AEs.

Results:

In total,
1404 patients were randomized; 83.5% were female; the mean age was 53.8 years,
75.4% were Caucasian, 1228 patients completed Part I and 713 patients continued
to Part II. Both 60 mg and 90 mg etoricoxib were superior to PBO for the
treatment of RA on both primary efficacy endpoints: change from baseline
DAS28-CRP score (Table 1A) and change from baseline PGAP score (Table 1B). For
DAS28-CRP, there was no significant treatment difference between etoricoxib 90
mg and 60 mg (Table 1A). Etoricoxib 90 mg demonstrated a small, but
statistically significant decrease in baseline PGAP score as compared to 60 mg (Table
1B). In Part II, inadequate pain responders did not experience a significant
decrease in PGAP score after increasing the etoricoxib dose from 60 mg to 90 mg
compared to inadequate pain responders who stayed on 60 mg (Table 1C). In
both etoricoxib 90 mg and 60 mg groups, the incidence of SAEs and drug-related
AEs were similar between the two treatment groups.

Conclusion:

Both
etoricoxib 90 mg and 60 mg are superior to PBO in relieving the symptoms of RA.
Etoricoxib 90 mg vs 60 mg resulted in a statistically significant, though
small, improvement in PGAP score, but not DAS28-CRP. Dose escalation from 60 mg
to 90 mg in pain inadequate responders did not significantly improve efficacy. Both
etoricoxib 90 mg and 60 mg were well tolerated and no new safety signals were
identified.

 


Disclosure: K. Bickham, Merck Pharmaceuticals, 3,Merck Pharmaceuticals, 1; D. van der Heijde, Merck Human Health, 5; N. Rawal, None; J. Sieper, Abbott, Merck, Pfizer, UCB Pharma, Novartis, Eli Lilly, Janssen, 5,Abbott, Merck, Pfizer, UCB Pharma, Novartis, Eli Lilly, Janssen, 8; B. Scott, Merck Pharmaceuticals, 3,Merck Pharmaceuticals, 1; N. Frontera, Merck Pharmaceuticals, 3,Merck Pharmaceuticals, 1; S. Shah, Merck Pharmaceuticals, 3,Merck Pharmaceuticals, 1; P. Stryszak, Merck Pharmaceuticals, 3,Merck Pharmaceuticals, 1; D. Papanicolaou, Merck Pharmaceuticals, 3,Merck Pharmaceuticals, 1; Z. Popmihajlov, Merck Pharmaceuticals, 3,Merck Pharmaceuticals, 1; P. Peloso, Merck Pharmaceuticals, 3,Merck Pharmaceuticals, 1.

To cite this abstract in AMA style:

Bickham K, van der Heijde D, Rawal N, Sieper J, Scott B, Frontera N, Shah S, Stryszak P, Papanicolaou D, Popmihajlov Z, Peloso P. A Randomized, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of Etoricoxib in Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/a-randomized-clinical-trial-to-assess-the-relative-efficacy-and-tolerability-of-two-doses-of-etoricoxib-in-patients-with-rheumatoid-arthritis/. Accessed .
  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to 2015 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-randomized-clinical-trial-to-assess-the-relative-efficacy-and-tolerability-of-two-doses-of-etoricoxib-in-patients-with-rheumatoid-arthritis/

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 »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology