ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • 2019 ACR/ARP Annual Meeting
    • 2018 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP PRSYM
    • 2016 ACR/ARHP Annual Meeting
    • 2015 ACR/ARHP Annual Meeting
    • 2014 ACR/ARHP Annual Meeting
    • 2013 ACR/ARHP Annual Meeting
    • 2012 ACR/ARHP Annual Meeting
    • 2011 ACR/ARHP Annual Meeting
    • 2010 ACR/ARHP Annual Meeting
    • 2009 ACR/ARHP Annual Meeting
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • Register
    • View and print all favorites
    • Clear all your favorites
  • Meeting Resource Center

Abstract Number: 934

Effectiveness of FX006 Intra-Articular Injection in Patients with Knee Osteoarthritis Who Present with and without Clinical Inflammation at Baseline: A Pooled Analysis of Data from 3 Double-Blind, Randomized, Parallel-Group Clinical Trials

Herbert S. B. Baraf1, Christian Lattermann2, Deryk G. Jones3, Philip G. Conaghan4, Joelle Lufkin5, James Johnson6, Scott Kelley5 and Neil Bodick5, 1Center for Rheumatology and Bone Research, Wheaton, MD, 2University of Kentucky, Orthopaedic Surgery and Sports Medicine, Lexington, KY, 3Ochsner Sports Medicine Institute, New Orleans, LA, 4Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 5Flexion Therapeutics, Inc., Burlington, MA, 6Summit Analytical, Denver, CO

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Clinical, corticosteroids, inflammation and osteoarthritis, Knee

  • Tweet
  • Email
  • Print
Save to PDF
Session Information

Date: Sunday, November 5, 2017

Session Title: Osteoarthritis – Clinical Aspects I: Pain and Functional Outcomes

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: Inflammation is a key contributor to osteoarthritis (OA).1 OA pain is mediated by interactions between inflammatory cytokines and other features including local tissue damage, synovitis and cellular response mechanisms.1 Synovitis is integral to OA, and is associated with symptom severity, joint dysfunction and cartilage loss.2 FX006, an extended-release formulation of triamcinolone acetonide (TA) for intra-articular (IA) injection, provided statistically and clinically significant, sustained improvements in pain/stiffness/function of knee OA vs placebo in clinical trials.3 We compared FX006 efficacy in patients with and without baseline inflammation determined by clinical assessment.

Methods: A pooled subgroup analysis of 3 double-blind, randomized, placebo-controlled trials (NCT01487161/NCT02116972/NCT02357459) was conducted. Patients with Kellgren-Lawrence grade 2/3 knee OA and Average Daily Pain (ADP)-intensity score ≥5–≤9 (0–10 Numerical Rating Scale) received a single IA injection of FX006 40 mg or saline-placebo. Investigators assessed index knees for clinical indicators of inflammation (effusion, Baker’s cyst, tenderness, swelling, and/or redness/heat). ADP-intensity was assessed daily for 24 weeks. Western Ontario and McMaster University Arthritis Index for OA (WOMAC; 0–4 Likert scale) pain (A), stiffness (B), and physical function (C) were assessed at baseline and Weeks 4/8/12.

Results: 349/586 patients (60%) had baseline clinical inflammation (Table). Changes from baseline in weekly mean ADP-intensity and WOMAC-A, B, C consistently favored FX006 vs saline-placebo (Figure). FX006 effect was enhanced, generally >2-fold, in patients with vs without baseline clinical inflammation: least squares mean differences for ADP and WOMAC-A, B, C, respectively, was –1.84 vs –0.74, –0.71 vs –0.27, -0.82 vs -0.41, and -0.69 vs -0.26 at Week 8, and –1.35 vs –0.37, –0.44 vs –0.16, -0.50 vs -0.27, and -0.44 vs -0.16 at Week 12.

Conclusion: FX006 provided sustained clinical improvement in knee OA vs saline-placebo irrespective of baseline clinical inflammation. Enhanced FX006 effect in patients with baseline clinical inflammation is consistent with the role of inflammation in OA pathogenesis and known anti-inflammatory action of TA. A drawback of this study is the lack of standardized measures of inflammation. Longer-term evaluations with objective inflammation measures (e.g., ultrasound, biomarkers) are needed.

1Robinson WH, et al. Nat Rev Rheumatol. 2016;12:580-92.

2Sellam J. Nat Rev Rheumatol. 2010;6(11):625-35.

3Conaghan P, et al. Osteoarthr Cartil. 2017;25:S432-S433.



Disclosure: H. S. B. Baraf, Flexion Therapeutics, 2,Pfizer Inc, 2,Abbvie, 8,Horizon, 8; C. Lattermann, Cartiheal, 5,Cartilage, 9,J Sports Physiology, 9,The Knee, 9,Orthopaedic Journal of Sports Medicine, 9,Cocoon, 1,International Cartilage Repair Society, 6,German-speaking Arthroscopy Society AGA, 6,Novartis Pharmaceutical Corporation, 5,Samumed, 5,Smith & Nephew, Inc., 2,Vericel, 5; D. G. Jones, Genzyme Corporation, 5,Mitek, 5,Musculoskeletal Transplant Foundation, 5,Musculoskeletal Transplant Foundation, 6,Sanofi-Aventis Pharmaceutical, 2,Zimmer, 7; P. G. Conaghan, Novartis Pharmaceutical Corporation, 5,Flexion Therapeutics, 5,AbbVie, 5,Infirst, 5,Medivir, 5,Merck Serono, 5,ONO Pharmaceutical Co., 5; J. Lufkin, Flexion Therapeutics, 3,Flexion Therapeutics, 1; J. Johnson, Flexion Therapeutics, 1,Flexion Therapeutics, 3,Flexion Therapeutics, 5,Summit Analytical, LLC, 3,Acura Pharmaceuticals, 5,Iroko Pharmaceuticals, 5,IX Biopharma, 5,Tolmar, Inc., 5; S. Kelley, Flexion Therapeutics, 1,Flexion Therapeutics, 3; N. Bodick, Flexion Therapeutics, 1,Flexion Therapeutics, 3.

To cite this abstract in AMA style:

Baraf HSB, Lattermann C, Jones DG, Conaghan PG, Lufkin J, Johnson J, Kelley S, Bodick N. Effectiveness of FX006 Intra-Articular Injection in Patients with Knee Osteoarthritis Who Present with and without Clinical Inflammation at Baseline: A Pooled Analysis of Data from 3 Double-Blind, Randomized, Parallel-Group Clinical Trials [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/effectiveness-of-fx006-intra-articular-injection-in-patients-with-knee-osteoarthritis-who-present-with-and-without-clinical-inflammation-at-baseline-a-pooled-analysis-of-data-from-3-double-blind-ran/. Accessed December 12, 2019.
  • Tweet
  • Email
  • Print
Save to PDF

« Back to 2017 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/effectiveness-of-fx006-intra-articular-injection-in-patients-with-knee-osteoarthritis-who-present-with-and-without-clinical-inflammation-at-baseline-a-pooled-analysis-of-data-from-3-double-blind-ran/

Advanced Search

Your Favorites

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

Annual Meeting in Atlanta, Georgia

© COPYRIGHT 2019 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

  • Home
  • Meetings Archive
  • Advanced Search
  • Meeting Resource Center
  • Online Journal
  • Privacy Policy
  • Permissions Policies
loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
This site uses cookies: Find out more.