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OBJECTIVE: Long-term gout management is based on reducing serum urate by using urate-lowering therapy (ULT). A lifelong treat-to-target approach is advocated, although a ULT (taper to) stop attempt can be considered (treat-to-avoid symptoms approach) during remission. Exploring the beliefs of patients with gout on long-term ULT strategies during remission is important for optimizing gout management. We aimed to identify factors that influence the decision for continuation or discontinuation of ULT and to determine their relative importance according to patients with gout in remission. METHODS: A mixed-methods design was used. First, semistructured interviews (substudy 1) were conducted to identify barriers and facilitators for the (dis)continuation of ULT using inductive thematic analysis. Afterwards, these barriers/facilitators were summarized into neutrally phrased items and used in a maximum difference scaling study (substudy 2) to determine their relative importance using the rescaled probability score. RESULTS: Substudies 1 and 2 included 18 and 156 patients, respectively. Substudy 1 yielded 22 items within 10 overarching themes. Substudy 2 revealed that the perceived risk of joint damage and gout flares and that ULT use gives some assurance were the most important items. The costs, ease of receiving ULT, and its practical use were the least important items. CONCLUSION: These results can aid shared decision-making and provide input for what is important to discuss with patients with gout in remission when they consider ULT discontinuation. The emphasis should be on the risk of having gout flares and joint damage, not so much on facilitating how easily medication is received.

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BACKGROUND: Long-term gout treatment is based on reducing serum urate levels using urate-lowering therapy (ULT). Most guidelines recommend using a lifelong continuation treat-to-target (T2T) strategy, in which ULT is dosed or combined until a serum urate target has been reached and maintained. However, a frequently used alternative strategy in clinical practice is a treat-to-avoid-symptoms (T2S) ULT discontinuation strategy, with the possibility of restarting the medication. This latter strategy aims at an acceptable symptom state, regardless of serum urate levels. High-quality evidence to support either strategy for patients in prolonged remission while using ULT is lacking. METHODS: We developed an investigator-driven pragmatic, open-label, multicentre, randomized, superiority treatment strategy trial (GO TEST Finale). At least 278 gout patients using ULT who are in remission (>12 months, preliminary gout remission criteria) will be randomized 1:1 to a continued T2T strategy (treatment target serum urate < 0.36 mmol/l) or switched to a T2S discontinuation strategy in which ULT is tapered to stop and restarted in case of (persistent or recurrent) flaring. The primary outcome is the between-group difference in the proportion of patients not in remission during the last 6 months of 24 months follow-up and will be analyzed using a two proportion z test. Secondary outcomes are group differences in gout flare incidence, reintroduction or adaptation of ULT, use of anti-inflammatory drugs, serum urate changes, occurrence of adverse events (with a special interest in cardiovascular and renal events), and cost-effectiveness. DISCUSSION: This study will be the first clinical trial comparing two ULT treatment strategies in patients with gout in remission. It will contribute to more specific and unambiguous guideline recommendations and improved cost-effectiveness of long-term gout treatment. It also paves the way (exploratory) to individualized long-term ULT treatment. In this article, we elaborate on some of our trial design choices and their clinical and methodological consequences. TRIAL REGISTRATION: International Clinical Trial Registry Platform (ICTRP) NL9245. Registered on 2 February 2021 (METC Oost-Nederland NL74350.091.20); EudraCT EUCTR2020-005730-15-NL. Registered on 11 January 2021.

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Gout is characterized by acute arthritis due to the deposition of urate crystals in joints in a state of hyperuricemia. Gout is a clinical diagnosis and can be confirmed with a joint aspiration to examine the synovial fluid with a polarized light microscopy. If a joint aspiration is not feasible or inconclusive, ultrasound or Dual Energy Computed Tomography (DECT) can be considered. Pharmacological treatment of gout consists of treating acute flares with anti-inflammatory drugs and, if indicated, of urate lowering therapies (ULT). (Inter)national rheumatology guidelines recommend the use of ULT indefinite by a treat-to-target approach, but there is discussion whether (certain) patients might also be treated by a treat-to-avoid-symptoms approach. Two large Dutch trials are comparing these strategies in gout patients. Most gout patients have cardiovascular and metabolic comorbidities and therefore an indication for cardiovascular risk assessment.

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