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Low-dose SoluMatrix diclofenac in patients with osteoarthritis pain: impact on quality of life in a controlled trial

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Abstract

Low-dose SoluMatrix diclofenac was developed to provide effective pain relief for osteoarthritis pain. We evaluated the effects of SoluMatrix diclofenac on health-related quality of life (HRQoL) measures in patients with osteoarthritis, hypothesizing that SoluMatrix-treated patients would experience significant improvement compared with placebo. In this 12-week, phase 3 randomized controlled trial, 305 patients with osteoarthritis of the hip or knee received SoluMatrix diclofenac 35 mg three times (TID) or twice (BID) daily or placebo. Measures included HRQoL, assessed by Short Form 36 (SF-36, version 2), and pain, stiffness, and physical function, assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and at week 12. Descriptive statistics were calculated for mean changes from baseline; inferential statistics compared treatment groups with placebo. SoluMatrix diclofenac 35 mg BID (6.2 [0.75]; P = 0.0048) or TID (6.6 [0.80]; P = 0.0014) produced large improvements in the SF-36 physical component summary (PCS) scores at week 12 (least squares mean change from baseline [SE]) compared with placebo (3.5 [0.78]). Minimum clinically important differences were observed in six out of eight SF-36 domains among patients in SoluMatrix diclofenac groups and five out of eight domains in the placebo group; treatment with SoluMatrix diclofenac 35 mg TID produced significant improvements (P ≤ 0.03) in five out of eight domains versus placebo. SoluMatrix diclofenac 35 mg TID significantly improved responses to 23 out of 24 questions in the WOMAC versus placebo (P ≤ 0.0334). Low-dose SoluMatrix diclofenac 35 mg TID and BID significantly improved HRQoL, pain, stiffness, and physical function in patients with osteoarthritis of the hip or knee.

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Notes

  1. SoluMatrix® is a registered trademark of iCeutica Pty Ltd. and is licensed to Iroko.

  2. ZORVOLEX® is a registered trademark of Iroko Properties, Inc.

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Acknowledgements

The authors would like to thank the following individuals: Mark Jaros, PhD; Jennifer Nezzer, MS; Susan Whitcher; Aaron Danna; Michael Kuss; Garen Manvelian, MD; Daniel Solorio; Olaolu Imasogie, MD; Claire Sheridan, PhD; Melanie Lauterio, PhD; and the investigators and patients who participated in this study. Ewa Wandzioch, PhD; Jill See, PhD; and Colville Brown, MD, of AlphaBioCom, LLC (King of Prussia, PA), provided the editorial support for this manuscript. Funding was provided by Iroko.

Author information

Authors and Affiliations

  1. Stanford University, Palo Alto, CA, USA

    Vibeke Strand

  2. Drexel University College of Medicine, Philadelphia, PA, USA

    Martin Bergman

  3. Medicine Service and Center for Surgical Medical Acute Care Research and Transitions, VA Medical Center, Birmingham, AL, USA

    Jasvinder A. Singh

  4. Hospital for Special Surgery, New York, NY, USA

    Allan Gibofsky

  5. Altoona Center for Clinical Research, Duncansville, PA, USA

    Alan Kivitz

  6. Iroko Pharmaceuticals, LLC, Philadelphia, PA, USA

    Clarence Young

  7. Velicept Therapeutics, 101 Lindenwood Drive, Suite 125, Malvern, PA, 19355, USA

    Clarence Young

Authors
  1. Vibeke Strand
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  2. Martin Bergman
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  3. Jasvinder A. Singh
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  4. Allan Gibofsky
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  5. Alan Kivitz
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  6. Clarence Young
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Corresponding author

Correspondence to Clarence Young.

Ethics declarations

All patients provided written informed consent prior to any protocol-specified procedures, and the study was approved by the Copernicus Group Institutional Review Board (Research Triangle Park, NC, USA) and was conducted in accordance with the standards and ethical principles of the International Conference on Harmonization Good Clinical Practice Guidelines and the Declaration of Helsinki at 40 sites in the USA.

Conflict of interest

Vibeke Strand is a consultant to Afferent; Ampio; Bioventus; Carbylan; Eupraxia; Flexion; Iroko Pharmaceuticals, LLC; Lilly; Pfizer; Sanofi; and SKK. She is a founding member of the executive committee of OMERACT, an organization that develops and validates outcome measures in rheumatology. Martin Bergman serves as a consultant to Iroko Pharmaceuticals, LLC; Amgen; Celgene; Roche; AstraZeneca; AbbVie; and Pfizer and is a stockholder in Merck & Co, Inc.; Johnson & Johnson; Pfizer; and Bristol-Myers Squibb. Jasvinder A. Singh has received research grants from Takeda and Savient and consultant fees from Savient; Takeda; Regeneron; Merz; Bioiberica; Crealta; WebMD; UBM, LLC; Allergan; and Iroko Pharmaceuticals, LLC. Dr. Singh serves as the principal investigator for an investigator-initiated study funded by Horizon Pharmaceuticals through a grant to DINORA, Inc., and is also a member of the executive committee of OMERACT, an organization that develops and validates outcome measures in rheumatology. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the US government. Allan Gibofsky is a stock shareholder of GlaxoSmithKline PLC, Bristol-Myers Squibb, Johnson & Johnson, Amgen, Pfizer, and AbbVie and serves as a consultant for Takeda, Amgen, AbbVie, UCB, Genentech, Horizon, and Iroko Pharmaceuticals, LLC. Alan Kivitz is a speaker for Iroko Pharmaceuticals, LLC. Clarence Young was an employee of Iroko Pharmaceuticals, LLC, at the time this study was conducted.

Additional information

Clarence Young was an employee of Iroko Pharmaceuticals, LLC, at the time this study was conducted.

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Strand, V., Bergman, M., Singh, J.A. et al. Low-dose SoluMatrix diclofenac in patients with osteoarthritis pain: impact on quality of life in a controlled trial. Clin Rheumatol 36, 1357–1367 (2017). https://doi.org/10.1007/s10067-017-3569-x

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  • DOI: https://doi.org/10.1007/s10067-017-3569-x

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