J-Y Reginster1, S Reiter-Niesert2, O Bruyère3, F Berenbaum4, M-L Brandi5, J Branco6, J-P Devogelaer7, G Herrero-Beaumont8, J Kanis9, S Maggi10, E Maheu11, P Richette12, R Rizzoli13, C Cooper14. 1. Department of Public Health Sciences, University of Liège and CHU Centre Ville, Liège, Belgium. Electronic address: jyreginster@ulg.ac.be. 2. Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany. 3. Department of Public Health Sciences, University of Liège and CHU Centre Ville, Liège, Belgium. 4. Department of Rheumatology, University Pierre and Marie Curie AP-HP, Hôpital Saint-Antoine, Paris, France; University of Paris06, INSERM, UMR-S938, Paris, France. 5. Department of Internal Medicine, University of Florence, Florence, Italy. 6. CEDOC - Department of Rheumatology, Faculdade de Ciências Médicas, Universidade Novade Lisboa, Lisbon, Portugal; CHLO, EPE-Hospital Egas Moniz, Lisbon, Portugal. 7. Department of Rheumatology, Saint-Luc University Hospital, Catholic University, Louvain, Belgium. 8. Bone and Joint Research Unit, Fundación Jiménez Diaz, Madrid, Spain. 9. Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Sheffield, UK. 10. Aging Program, National Research Council, Padova, Italy. 11. Rheumatology Department, AP-HP, St-Antoine Hospital, Paris, France. 12. Paris Diderot University, UFR médicale, Paris, France; AP-HP, Hôpital Lariboisière, fédération de Rhumatologie, Paris, France. 13. Service of Bone Diseases, Department of Rehabilitation and Geriatrics, University Hospitals and Faculty of Medicine of Geneva, Geneva, Switzerland. 14. NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, UK; MRC Epidemiology Resource Centre, University of Southampton, Southampton, UK.
Abstract
OBJECTIVE: The European Society on Clinical and Economic aspects of Osteoporosis and Osteoarthritis (ESCEO) organised a working group to evaluate the need for updating the current European guideline on clinical investigation of drugs used in the treatment of osteoarthritis (OA). DESIGN: Areas of potential attention were identified and the need for modifications, update or clarification was examined. Proposals were then developed based on literature reviews and through a consensus process. RESULTS: It was agreed that the current guideline overall still reflects the current knowledge in OA, although two possible modifications were identified. The first relates to the number and timing of measurements required as primary endpoints during clinical trials of symptom-relieving drugs, either drugs with rapid onset of action or slow acting drugs. The suggested modifications are intended to take into consideration the time related clinical need and expected time response to these drugs - i.e., a more early effect for the first category in addition to the maintenance of effect, a more continuous benefit over the long-term for the latter - in the timing of assessments. Secondly, values above which a benefit over placebo should be considered clinically relevant were considered. Based on literature reviews, the most consensual values were determined for primary endpoints of both symptom-relieving drugs (i.e., pain intensity on a visual analogue scale (VAS)) and disease-modifying drugs (i.e., radiographic joint-space narrowing). CONCLUSIONS: This working document might be considered by the European regulatory authorities in a future update of the guideline for the registration of drugs in OA.
OBJECTIVE: The European Society on Clinical and Economic aspects of Osteoporosis and Osteoarthritis (ESCEO) organised a working group to evaluate the need for updating the current European guideline on clinical investigation of drugs used in the treatment of osteoarthritis (OA). DESIGN: Areas of potential attention were identified and the need for modifications, update or clarification was examined. Proposals were then developed based on literature reviews and through a consensus process. RESULTS: It was agreed that the current guideline overall still reflects the current knowledge in OA, although two possible modifications were identified. The first relates to the number and timing of measurements required as primary endpoints during clinical trials of symptom-relieving drugs, either drugs with rapid onset of action or slow acting drugs. The suggested modifications are intended to take into consideration the time related clinical need and expected time response to these drugs - i.e., a more early effect for the first category in addition to the maintenance of effect, a more continuous benefit over the long-term for the latter - in the timing of assessments. Secondly, values above which a benefit over placebo should be considered clinically relevant were considered. Based on literature reviews, the most consensual values were determined for primary endpoints of both symptom-relieving drugs (i.e., pain intensity on a visual analogue scale (VAS)) and disease-modifying drugs (i.e., radiographic joint-space narrowing). CONCLUSIONS: This working document might be considered by the European regulatory authorities in a future update of the guideline for the registration of drugs in OA.
Authors: Jean-Yves L Reginster; Nigel K Arden; Ida K Haugen; Francois Rannou; Etienne Cavalier; Olivier Bruyère; Jaime Branco; Roland Chapurlat; Sabine Collaud Basset; Nasser M Al-Daghri; Elaine M Dennison; Gabriel Herrero-Beaumont; Andrea Laslop; Burkhard F Leeb; Stefania Maggi; Ouafa Mkinsi; Anton S Povzun; Daniel Prieto-Alhambra; Thierry Thomas; Daniel Uebelhart; Nicola Veronese; Cyrus Cooper Journal: Semin Arthritis Rheum Date: 2017-12-07 Impact factor: 5.532
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Authors: Nebojsa Skrepnik; Andrew Spitzer; Roy Altman; John Hoekstra; John Stewart; Richard Toselli Journal: JMIR Mhealth Uhealth Date: 2017-05-09 Impact factor: 4.773
Authors: Charlotte Beaudart; Eugène McCloskey; Olivier Bruyère; Matteo Cesari; Yves Rolland; René Rizzoli; Islène Araujo de Carvalho; Jotheeswaran Amuthavalli Thiyagarajan; Ivan Bautmans; Marie-Claude Bertière; Maria Luisa Brandi; Nasser M Al-Daghri; Nansa Burlet; Etienne Cavalier; Francesca Cerreta; Antonio Cherubini; Roger Fielding; Evelien Gielen; Francesco Landi; Jean Petermans; Jean-Yves Reginster; Marjolein Visser; John Kanis; Cyrus Cooper Journal: BMC Geriatr Date: 2016-10-05 Impact factor: 3.921
Authors: Camille Parsons; Nicholas R Fuggle; Mark H Edwards; Lyndsey Goulston; Anna E Litwic; Darshan Jagannath; Suzan van der Pas; Cyrus Cooper; Elaine M Dennison Journal: Aging Clin Exp Res Date: 2017-11-03 Impact factor: 3.636