Cervical Spine Involvement among Patients with Rheumatoid Arthritis Treated Actively with Treat-to-target Strategy: 10-year Results of the NEO-RACo Study

Tia Sandström; Vappu Rantalaiho; Timo Yli-Kerttula; Hannu Kautiainen; Timo Malmi; Anna Karjalainen; Tea Uusitalo; Heikki Julkunen; Oili Kaipiainen-Seppänen; Leena Paimela; Kari Puolakka; Toini Uutela; Timo Möttönen; Pekka Hannonen; Marjatta Leirisalo-Repo; Leena Laasonen; Markku Kauppi; for the NEO-RACo Study Group

doi:10.3899/jrheum.190139

Abstract

Objective. To evaluate the development of radiological changes of the cervical spine in patients with rheumatoid arthritis (RA) in the NEO-RACo trial treated with an intensive, remission-targeted combination of conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and additional infliximab (IFX) or placebo (PLA) for the first 6 months.

Methods. Ninety-nine patients with early, DMARD-naive RA were treated with a triple combination of csDMARD and prednisolone, and randomized to double-blindly receive either IFX (FIN-RACo+IFX) or PLA (FIN-RACo+PLA) infusions during the first 6 months. After 2 years the treatment strategies became unrestricted, but the treatment goal was strict NEO-RACo remission. At the 10-year visit, radiographs of the cervical spine were taken of 85 patients (38 in the FIN-RACo+IFX group and 47 in the FIN-RACo+PLA group). The study was registered at ClinicalTrials.gov (NCT 00908089).

Results. There were 4/85 patients (4.7%) with cervical spine involvement (CSI) by 10 years. Atlantoaxial subluxation was found in 2/85 patients (2.4%), both in the FIN-RACo+IFX group, and none in the FIN-RACo+PLA group. Atlantoaxial impaction was found in 1/85 patients (1.2%) in the FIN-RACo+IFX group. Subaxial subluxation was found in 1/85 patients (1.2%).

Conclusion. Early and intensive remission-targeted treatment has reduced the incidence of CSI and our results show that intensive treatment also prevents its development in the long run.

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Footnotes

This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish.