Karsdal, M., Tambiah, J., Felson, D., Ladel, C., Nikolov, N., Hodgins, D., Bihlet, A., Neogi, T., Baatenburg De Jong, C., Bay-Jensen, A., Baron, R., Laslop, A., Mobasheri, A., & Kraus, V. (2023). Reflections from the OARSI 2022 clinical trials symposium: The pain of OA—Deconstruction of pain and patient-reported outcome measures for the benefit of patients and clinical trial design. Osteoarthritis and Cartilage, Volume 31, Issue 10, 2023, Pages 1293-1302, ISSN 1063-4584, https://doi.org/10.1016/j.joca.2023.06.006
Reflections from the OARSI 2022 clinical trials symposium : the pain of OA—Deconstruction of pain and patient-reported outcome measures for the benefit of patients and clinical trial design
|Author:||Karsdal, MA1,2; Tambiah, J3; Felson, D4;|
1Nordic Bioscience, Herlev, Denmark
2Southern Danish University, Odense, Denmark
3Biosplice Therapeutics, San Diego, USA
4Boston University School of Medicine, Boston, Massachusetts, USA
5CHL4special consultancy, Darmstadt, Germany, Darmstadt, Germany
6Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
7Dynamic Metrics Limited, Codicote, UK
8NBCD A/S, Herlev, Denamrk
9Dutch Arthritis Society, Amsterdam, the Netherlands
10University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany
11Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency, Amsterdam, The Netherlands
12Bundesamt für Sicherheit im Gesundheitswesen (BASG), Vienna, Austria
13Research Unit of Health Sciences and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland
14Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania
15Department of Joint Surgery, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
16World Health Organization Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Aging, Université de Liège, Liege, Belgium
17Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, USA
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe2023070690323
|Publish Date:|| 2024-06-26
Background/Objectives: Osteoarthritis (OA) drug development is hampered by a number of challenges. One of the main challenges is the apparent discordance between pain and structure, which has had a significant impact on drug development programs and has led to hesitance among stakeholders. Since 2017, the Clinical Trials Symposium (CTS) has been hosted under the Osteoarthritis Research Society International (OARSI) leadership. OARSI and the CTS steering committee yearly invite and encourage discussions on selected special subject matter between regulators, drug developers, clinicians, clinical researchers, biomarker specialists, and basic scientists to progress drug development in the OA field.
Methods: The main topic for the 2022 OARSI CTS was to elucidate the many facets of pain in OA and to enable a discussion between regulators (Food and Drug Administration (FDA) and the European Medicines Agency (EMA)) and drug developers to clarify outcomes and study designs for OA drug development.
Results: Signs or symptoms indicative of nociceptive pain occur in 50‐70% of OA patients, neuropathic-like pain in 15‐30% of patients, and nociplastic pain in 15‐50% of patients. Weight-bearing knee pain is associated with bone marrow lesions and effusions. There are currently no simple objective functional tests whose improvements correlate with patient perceptions.
Conclusions: The CTS participants, in collaboration with the FDA and EMA, raised several suggestions that they consider key to future clinical trials in OA including the need for more precise differentiation of pain symptoms and mechanisms, and methods to reduce placebo responses in OA trials.
Osteoarthritis and cartilage
|Pages:||1293 - 1302|
|Type of Publication:||
A2 Review article in a scientific journal
|Field of Science:||
3121 General medicine, internal medicine and other clinical medicine
© 2023. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http:/creativecommons.org/licenses/by-nc-nd/4.0/