ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • 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: 2195

BMI Has Minimal Effect on Reduction of Symptoms in Patients with Osteoarthritis of the Knee Treated with Diclofenac 1% Gel

Joel A. Block1, Bharat Patel 2 and Sandy Yacoub Garas 3, 1Rush University Medical Center, Chicago, IL, 2GlaxoSmithKline Consumer Healthcare, Weybridge, United Kingdom, 3GlaxoSmithKline Consumer Healthcare, Warren, NJ

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: analgesics, body mass, Nonsteroidal antiinflammatory drugs (NSAIDs), osteoarthritis and pain management

  • Tweet
  • Email
  • Print
Session Information

Date: Tuesday, November 12, 2019

Session Title: Osteoarthritis – Clinical Poster II

Session Type: Poster Session (Tuesday)

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

Background/Purpose: Clinical trials demonstrate that diclofenac sodium gel 1% (DSG 1%), a topical NSAID, provides significantly better pain relief than vehicle placebo for patients with osteoarthritis (OA) of the knee. As patient BMI may affect the systemic availability and the volume of distribution of topical therapeutics, a post-hoc analysis was conducted to determine whether BMI has any clinical impact on the efficacy of DSG 1% in patients with OA of the knee.

Methods: This analysis pooled data from 3 vehicle-controlled studies of DSG 1%, VOSG-PN-304, VOSG-PN-310 and VOSG-PN-316, all double-blind studies with similar design and efficacy end-points, including Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain, function, and stiffness and pain on movement (POM). Efficacy data were analyzed as change from baseline and stratified by 3 BMI groups, (< 25, ≥25 to < 30, ≥30 kg/m2) at each visit (1, 4, 8 and 12 weeks). Populations included the Intention to Treat (ITT) efficacy population (all patients randomized and treated), and the Modified Efficacy Subset (MES) (patients with no decline in POM score between the screening and baseline visits and a score of 0-1 on the WOMAC abridged pain index for the contralateral knee). The treatment by BMI interaction from an analysis of covariance model was used for assessment.

Results: Improvement from baseline was larger for DSG 1% compared to vehicle in all 3 BMI groups for all 4 efficacy measures at each time point in both the ITT and MES populations. There were no significant differences in treatment effects between the 3 BMI groups at any time point for all 4 efficacy measures for both the ITT and MES population. Mean treatment effect (DSG 1% minus vehicle) at Week 12 and P-value for difference between < 25 (n=203), ≥25 to < 30 (n=460), ≥30 (n=751) kg/m2 BMI groups, respectively were: WOMAC pain, 1.01, 0.87, 0.79 (P=.94); POM, 9.66, 7.13, 6.06 (P=.71); WOMAC function, 2.38, 2.97, 3.77 (P=.78); WOMAC stiffness, 0.30, 0.47, 0.45 (P=.84) in the ITT population and WOMAC pain, 0.75, 1.48, 1.23 (P=.69); POM, 8.80, 10.39, 8.79 (P=.91); WOMAC function, 1.78, 4.99, 5.30 (P=.40); WOMAC stiffness, 0.22, 0.68, 0.66 (P=.37) in the MES population.

Conclusion: In this pooled analysis, patients treated with DSG 1% showed larger improvement from baseline in all 3 BMI groups, for all 4 efficacy measures, and at each time point compared to vehicle. There were no significant differences in efficacy between the 3 BMI groups, indicating that DSG 1% is efficacious regardless of BMI in patients with OA of the knee and that dose adjustments based on body size are not necessary.


Disclosure: J. Block, Abbvie, 2, ACR, 6, Agios, 7, Daiichi-Sankyo, 7, GlaxoSmithKline Consumer Healthcare, 5, Jannsen, 2, Medivir, 5, Novartis, 2, OARSI, Omeros, 7, Pfizer, 2, TissueGene, 2, Zynerba Pharma, 5; B. Patel, GlaxoSmithKline Consumer Healthcare, 3; S. Yacoub Garas, GlaxoSmithKline Consumer Healthcare, 3.

To cite this abstract in AMA style:

Block J, Patel B, Yacoub Garas S. BMI Has Minimal Effect on Reduction of Symptoms in Patients with Osteoarthritis of the Knee Treated with Diclofenac 1% Gel [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/bmi-has-minimal-effect-on-reduction-of-symptoms-in-patients-with-osteoarthritis-of-the-knee-treated-with-diclofenac-1-gel/. Accessed February 3, 2023.
  • Tweet
  • Email
  • Print

« Back to 2019 ACR/ARP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/bmi-has-minimal-effect-on-reduction-of-symptoms-in-patients-with-osteoarthritis-of-the-knee-treated-with-diclofenac-1-gel/

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 »

ACR Pediatric Rheumatology Symposium 2020

© COPYRIGHT 2023 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

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