Effect of an intensive smoking cessation intervention on smoking cessation and disease activity in patients with RA: a randomized controlled trial.

OBJECTIVES: To compare the effect of a 6-week individual intensive smoking cessation intervention in patients with RA, relative to treatment-as-usual, on the co-primary outcomes (1) successful smoking cessation and (2) achievement of EULAR clinical response (improvement in DAS28-CRP of >0.6) 3 months post-intervention. Secondary outcomes were number of swollen joints, tender joints, CRP, patient and physician global assessment, pain, fatigue, flare, physical function and health related quality of life. METHODS: A multicentre, open label, two-arm, parallel-group, randomized trial included daily smokers in RA remission or having low-to-moderate disease activity (DAS28-CRP ≤5.1). The control group received usual care, while the intervention group received in five individual counselling sessions over 6 weeks with a smoking cessation counsellor, and complimentary nicotine replacement therapy. Smoking cessation was defined as self-reported and confirmed by exhaled carbon monoxide. Patients were followed 3, 6 and 12 months post-intervention. RESULTS: Among 94 patients, 49 were randomized to the intervention group, 45 to usual care. At 3 months' follow-up, nine (18%) intervention vs two (4%) control group patients achieved smoking cessation, OR = 4.84 [95% CI 0.99-23.76]. In contrast to 12% vs 20% experiencing a EULAR clinical response (0.56 [0.18-1.72]). Among the secondary outcomes DAS28-CRP, tender joint count and CRP favoured the control group, whereas the remaining outcomes were similar between the groups. CONCLUSION: Patients receiving an intensive smoking cessation intervention achieved numerically higher cessation rates. In contrast, EULAR clinical response rates and several secondary outcomes tended to favour the control group. TRIAL REGISTRATION: ClinicalTrials.gov; NCT02901886.