Influence of co-morbid fibromyalgia on disease activity measures and response to tumour necrosis factor inhibitors in axial spondyloarthritis: results from a UK national register.

Objective: To quantify the extent to which co-morbid FM is associated with higher disease activity, worse quality of life (QoL) and poorer response to TNF inhibitors (TNFis) in patients with axial SpA. Methods: A prospective study recruiting across 83 centres in the UK. Clinical information and patient-reported measures were available, including 2011 criteria for FM. Multivariable linear regression was used to model the effect of meeting the FM criteria on disease activity, QoL and response to TNFis. Results: A total of 1757 participants were eligible for analyses, of whom 22.1% met criteria for FM. Those with co-morbid FM criteria had higher disease activity [BASDAI average difference FM+ - FM- 1.04 (95% CI 0.75, 1.33)] and worse QoL [Ankylosing Spondylitis Quality of Life score difference 1.42 (95% CI 0.88, 1.96)] after adjusting for demographic, clinical and lifestyle factors. Among 291 participants who commenced biologic therapy, BASDAI scores in those with co-morbid FM were 2.0 higher at baseline but decreased to 1.1 higher at 12 months. There was no significant difference in the likelihood of meeting Assessment of SpondyloArthritis international Society 20 criteria at 12 months. Less improvement in disease activity and QoL over 3 months of TNFi therapy was most strongly related to high scores on the FM criteria symptom severity scale component. Conclusion: Fulfilling criteria for FM has a modest impact on the assessment of axial SpA disease activity and QoL and does not significantly influence response to biologic therapy. Those with a high symptom severity scale on FM assessment may benefit from additional specific management for FM.

Patient-reported improvements in health are maintained 2†years after completing a short course of cognitive behaviour therapy, exercise or both treatments for chronic widespread pain: long-term results from the MUSICIAN randomised controlled trial.

OBJECTIVES: The MUSICIAN study has previously shown short-term benefit but only marginal cost-effectiveness for two non-pharmacological interventions for chronic widespread pain (CWP). We wished to determine their long-term effectiveness and cost-effectiveness. METHODS: A 2×2 factorial randomised controlled trial based in primary care in the UK. People were eligible if they were aged ≥25 years with CWP for which they had consulted their general practitioner. The interventions were a 6-month telephone cognitive behaviour therapy (tCBT) and/or a tailored exercise programme, in comparison to usual care. The primary outcome was patient-reported change in health. RESULTS: 884 persons were eligible, 442 were randomised and 81.7% were followed up 24 months post-treatment. In comparison to usual care (positive outcome 12.8%), tCBT (35.4%; OR 3.7 95% CI (1.8 to 8.0)), exercise (29.3%; OR 2.8 95% CI (1.3 to 6.0)) and both interventions (31.2%; OR 3.1 95% CI (1.3 to 6.0)) were significantly more effective. There was only a small decrease in effectiveness over time for individual and combined treatments. Those with more intense/disabling pain, higher distress and those who exhibited passive coping at baseline were more likely to have a positive outcome with tCBT than persons without these characteristics. tCBT was associated with the greatest increase in quality of life and lowest costs. Cost per quality adjusted life year was £3957-£5917 depending on method of analysis. CONCLUSIONS: A short course of tCBT for people with CWP was effective long-term and was highly cost-effective. Exercise was also effective but delivered positive outcome for fewer patients at greater cost, and there was no advantage for patients receiving both interventions. TRIAL REGISTRATION NUMBER: ISRCTN67013851.