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. 2023 Jun:251:109344.
doi: 10.1016/j.clim.2023.109344. Epub 2023 Apr 23.

Gathering expert consensus to inform a proposed trial in chronic nonbacterial osteomyelitis (CNO)

C M Hedrich  1 , M W Beresford  2 , F Dedeoglu  3 , G Hahn  4 , S R Hofmann  5 , A F Jansson  6 , R M Laxer  7 , P Miettunen  8 , H Morbach  9 , C E Pain  10 , A V Ramanan  11 , E Roberts  12 , A Schnabel  5 , A Theos  13 , L Whitty  14 , Y Zhao  15 , P J Ferguson  16 , H J Girschick  17
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Gathering expert consensus to inform a proposed trial in chronic nonbacterial osteomyelitis (CNO)

C M Hedrich et al. Clin Immunol. 2023 Jun.

Abstract

Chronic nonbacterial osteomyelitis (CNO) is an autoinflammatory bone disease that primarily affects children and adolescents. CNO is associated with pain, bone swelling, deformity, and fractures. Its pathophysiology is characterized by increased inflammasome assembly and imbalanced expression of cytokines. Treatment is currently based on personal experience, case series and resulting expert recommendations. Randomized controlled trials (RCTs) have not been initiated because of the rarity of CNO, expired patent protection of some medications, and the absence of agreed outcome measures. An international group of fourteen CNO experts and two patient/parent representatives was assembled to generate consensus to inform and conduct future RCTs. The exercise delivered consensus inclusion and exclusion criteria, patent protected (excludes TNF inhibitors) treatments of immediate interest (biological DMARDs targeting IL-1 and IL-17), primary (improvement of pain; physician global assessment) and secondary endpoints (improved MRI; improved PedCNO score which includes physician and patient global scores) for future RCTs in CNO.

Keywords: CNO; CRMO; Consensus; Osteomyelitis; Outcome; Study; Treatment; Trial.

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Conflict of interest statement

Declaration of Competing Interest In the past, CMH received research funding from Novartis for research in psoriasis (secukinumab programme, 2017–2019). In the past 5 years, CMH received speaker's honoraria from Roche, and was involved in advisory boards hosted by Novartis and Cancer Research UK (CRUK). CMH, PJF, HJG, and YZ participated in advisory boards on the use of canakinumab in inflammatory bone disease hosted by Novartis. RML is a consultant to Novartis and SOBI.

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