A Randomized, Placebo‐Controlled Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase: Primary Efficacy and Safety Findings

Botson, JK; Saag, K; Peterson, J; Parikh, N; Ong, S; La, D; LoCicero, K; Obermeyer, K; Xin, Y; Chamberlain, J; LaMoreaux, B; Verma, S; Sainati, S; Grewal, S; Majjhoo, A; Tesser, JRP; Weinblatt, ME

doi:10.1002/art.42335

Gout & crystal arthritis

A Randomized, Placebo‐Controlled Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase: Primary Efficacy and Safety Findings

Arthritis RheumatolPublished 16 Dec 2022Randomised controlled trial

Primary result · Treatment responseResultBetween-group difference 32.3 % 95% CI 16.3%–48.3%

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Authors' conclusion

MTX cotherapy markedly increased pegloticase response rate over placebo (71.0% versus 38.5%) during month 6 with no new safety signals.

Study context

Population: Adults with uncontrolled gout (serum urate ≥7 mg/dl, oral ULT failure or intolerance, ongoing gout symptoms); eGFR <40 ml/minute/1.73 m² excludedrandomised
Participants: 152 adults

Comparison: Pegloticase plus oral methotrexate (MTX) vs pegloticase plus placebo for 52 weeks
MTXn = 100
Placebon = 52reference
Primary endpoint: Proportion of treatment responders during month 6 (serum urate <6 mg/dl for ≥80% of visits during weeks 20-24)
Follow-up: Month 6

Methodological detailsdouble-blind, placebo-controlled, 2:1 randomisation

Double-blind
Placebo-controlled
2:1 randomisation

Primary result

Treatment response

Between-group difference

32.3 %

95% CI 16.3%–48.3%

P < 0.0001 for between-group difference

Events by treatment group

MTX71.0%71 of 100

Placebo38.5%20 of 52

MTXvs Placebo

between-group difference 32.3 % (95% CI 16.3%–48.3%); P < 0.0001 for between-group difference

As reported in the abstract

Further findings

Antidrug antibody positivity

Lower in the MTX group

Safety

≥1 AE · first 6 months

MTX81.3%

Placebo95.9%

Gout flare (most common AE) · first 6 months

MTX66.7%

Placebo69.4%

Infusion reactions

P < 0.001

MTX4.2%

Placebo30.6%

≥1 adverse event (AE): 96 MTX and 49 placebo patients in safety analysis
Infusion reactions: anaphylaxis: 1 MTX patient, 0 placebo patients

AEs and serious AEs

Comparable between groups

Original publication

A Randomized, Placebo‐Controlled Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase: Primary Efficacy and Safety Findings. Arthritis Rheumatol. Published 16 December 2022. doi:10.1002/art.42335

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