Background: Patients with chronic inflammatory arthritis (CIA) treated with anti-TNF therapy are usually followed up by rheumatologists. Nurse-led rheumatology clinics have been proposed for patients with low disease activity or in remission. The purpose of this trial was to compare treatment outcomes from a nurse-led rheumatology clinic and a rheumatologist clinic for patients undergoing anti-TNF therapy with low disease activity or in remission.

Methods: A randomized controlled trial (RCT) with a 12-month follow-up was conducted with 107 patients randomised into two groups with a 6-month follow up to a nurse-led rheumatology clinic based on a person-centred care (intervention group; n=53) or to a rheumatologist-led clinic (control group; n=54). The intention of the interventional trial was to replace one of the two annual rheumatologist monitoring visits by a nurse-led rheumatology monitoring visit for patients undergoing anti-TNF therapy. Inclusion criteria were patients undergoing anti-TNF therapy and Disease Activity Score 28 (DAS28) ≤3.2. The hypothesis was that the outcomes from nurse-led clinic will not be inferior to those obtained by rheumatologist-led clinic at 12-month follow-up. Primary outcome was disease activity measured by DAS28.

Results: After 12 months 47 patients in the intervention group and 50 patients in the control group completed the trial and there were no differences (p=0.66) in mean change of DAS28 between the intervention or control group. There were no differences (p>0.05) in mean change in Visual Analogue Scales (VAS) for pain, Health Assessment Questionnaire (HAQ), satisfaction or security with the rheumatology care  between the two groups, see table.

Conclusion: In monitoring of anti-TNF therapy treatment outcomes for patients at a nurse-led rheumatology clinic are not inferior to those obtained by rheumatologist-led clinic at 12-month follow-up. The follow-up care of anti-TNF therapy may advantageously be performed by a nurse-led clinic based on a person-centred care. The results from this trial demonstrated that patients with CIA undergoing anti-TNF therapy, with low disease activity or in remission, could be monitored by a nurse-led rheumatology clinic without any differences in outcome as measured by DAS28.