Introduction Two subcutaneous injections of adalimumab in severe acute sciatica significantly reduced the number of back operations in a short-term randomised controlled clinical trial.
Objective To determine in a 3-year follow-up study whether the short-term benefit of adalimumab in sciatica is sustained over a longer period of time.
Methods The primary outcome of this analysis was incident discectomy. Three years after randomisation, information on surgery could be retrieved in 56/61 patients (92%).A multivariate Cox proportional hazard models, adjusted for potential confounders, was used to determine factors predisposing to surgery.
Results Twenty-three (41%) patients had back surgery within 3 years, 8/29 (28%) in the adalimumab group and 15/27 (56%) in the placebo group, p=0.04. Adalimumab injections reduced the need for back surgery by 61% (HR)=0.39 (95% CI 0.17 to 0.92). In a multivariate model, treatment with a tumour necrosis factor-α antagonist remained the strongest protective factor (HR=0.17, p=0.002). Other significant predictors of surgery were a good correlation between symptoms and MRI findings (HR=11.6, p=0.04), baseline intensity of leg pain (HR=1.3, p=0.06), intensity of back pain (HR=1.4, p=0.03) and duration of sickness leave (HR=1.01 per day, p=0.03).
Conclusion A short course of adalimumab in patients with severe acute sciatica significantly reduces the need for back surgery.
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Funding Unrestricted scientific grant from Abbott.
Conflict of interest This work is an investigator-sponsored study supported by an unrestricted grant from Abbott AG. The sponsor of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.
SG received from Abbott partial reimbursement of travel expenses related to the presentation of this trial at medical congresses as well as speaker honoraria for educational presentations not related to this work. AF has received consultancy and speaker honoraria from Abbott for educational presentations not related to this work. CG has received a speaker and advisory board member honorarium from Abbott.
PZ, FB and SV have no conflict of interest relating to this publication.
Patient consent Obtained.
Ethics approval Ethical committee of University Hospitals of Geneva, Switzerland.
Provenance and peer review Not commissioned; externally peer reviewed.