Anakinra versus treatment as usual in the treatment of acute gout // Anakinra versus standaardbehandeling bij acute jicht

Gout is a common form of inflammatory arthropathy, with hyperuricemia being the predominant risk factor. The close relationship between gout and hyperuricemia has led to treatment strategies wherein both the acute gout flare and hyperuricemia are targeted simultaneously. Currently available treatment options for gout flares (colchicine, corticosteroids and NSAIDs) are frequently contraindicated or poorly tolerated by gout patients due to presence of significant multi-morbidity. Anakinra (Kineretâ) is an IL-1 receptor antagonist presently indicated for the treatment of rheumatoid arthritis and Cryopyrin-Associated Periodic Syndromes. At present, anakinra has been studied in a handful of case series and small open label studies for its clinical efficacy and safety in acute gout. The objective of this study is to demonstrate non-inferiority of anakinra compared with the standard options in the treatment of acute gout flares. Also, to compare the safety and cost per quality-adjusted life day between anakinra and standard options and to compare the 3 and 12 months clinical outcome of patients initially treated with anakinra versus standard options and starting urate lowering therapy.

Measurements take place at day 1-7, months 3, 6, 9 and 12

Pain intensity at the primary joint during treatment follow-up time will be assessed using a 5-point Likert scale (1 = none; 2 = mild; 3 = moderate; 4 = severe; 5 = extreme) and a 100mm visual analog scale (0 = no pain, 100 = worst imaginable pain). Also a numeric rating scale (NRS) will be used to measure pain intensity (0 = no pain at all until 10 = worst imaginable pain) at day 1 -7 and during the occurence of an acute gout flare.

Swelling and joint tenderness will be measured on a 5-point Likert scale at day 1 -7 and during occurence of another acute gout flare..



Global assessment of overall wellbeing will be assessed using a 10 point NRS (0 = worst imaginable health until 10 = best imaginable wellbeing) at day 1 -7 and during the occurence of another acute gout flare.



Physical functioning will be assessed using the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) at day 1, 7, month 3,6,9 and 12



HR-QOL will be assessed using the medical outcomes survey short form 36 (SF-36) at day 1, 7, month 3,6,9 and 12



Work productivity will be assessed using the Work Productivity and Activity Impairment Questionnaire (WPAI) at day 1, 7, month 3,6,9 and 12. The direct and indirect costs will be calculated from the work productivity and health care volumes questionnaire filled in by the patient.

Intervention group:

generic name: anakinra, subcutaneous injections

dose: 100 mg/day

treatment duration: 5 days



Active control: (1 of the 3 treatment regimes)

1. generic name: colchicine

dose: 0.5 mg (2-3 dd)

duration: 90 days (for treatment gout flare
and as prophylaxis when starting urate
lowering therapy)

2. generic name: naproxen

dose: 500 mg (2dd)

duration: 90 days (for treatment gout flare
and as prophylaxis when starting urate
lowering therapy)

3. generic name: prednisolon

dose: 35 mg/day

duration: 5 days