Effect of an intensive smoking cessation intervention on smoking cessation and disease activity in patients with rheumatoid arthritis: a randomised controlled trial.

To compare the effect of a 6-week individual intensive smoking cessation intervention in patients with rheumatoid arthritis, 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) three 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. A multicentre, open label, two-arm, parallel-group, randomised trial included daily smokers in rheumatoid arthritis 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 six 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 postintervention. Among 94 patients, 49 were randomised to the intervention group, 45 to usual care. At 3-months' follow-up, nine (18%) intervention versus two (4%) control group patients achieved smoking cessation, OR = 4.84 [95%CI 0.99 to 23.76]). In contrast to 12% versus 20% experiencing a EULAR clinical response (0.56 [0.18 to 1.72]). Among the secondary outcomes DAS28-CRP, tender joint count and CRP favoured the control group, whereas the remaining outcomes were similar between groups. Patients receiving an intensive smoking cessation intervention achieved numerically higher cessation rates. In contrast, EULAR clinical response rates and several secondary outcomes tended to favor the control group. ClinicalTrials.gov; NCT02901886.