AIRTRIP
Trial question
What is the effect of anakinra on recurrent pericarditis among patients with colchicine resistance and corticosteroid dependence?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
67.0% female
33.0% male
N = 21
21 patients (14 female, 7 male)
Inclusion criteria: patients with recurrent pericarditis with ≥ 3 previous recurrences, CRP elevation, colchicine resistance, and corticosteroid dependence received anakinra at a dose of 2 mg/kg/day, up to 100 mg, for 6 months (or until a pericarditis recurrence) after an initial 2-month treatment with anakinra
Key exclusion criteria: pregnant or lactating; history of immunodepression, including a positive HIV test result; positive QuantiFERON (QFT-TB G In-Tube) test result or positive purified protein derivative test result (≥ 5 mm induration) after the first attack of pericarditis; live vaccinations within 3 months before the start of the trial; history of malignancy of any organ system, treated or untreated, within the past 5 years; history of significant other medical conditions that in the investigator's opinion would exclude a patient from participating in this trial; or history of recurrent and/or evidence of active bacterial, fungal, or viral infection(s)
Interventions
N=11 anakinra (continued treatment at a dose of 2 mg/kg/day, up to 100 mg, SC for another 6 months or until a pericarditis recurrence)
N=10 placebo (switched to identical placebo for another 6 months or until a pericarditis recurrence)
Primary outcome
Recurrent pericarditis
18.2
90
90.0 %
67.5 %
45.0 %
22.5 %
0.0 %
Anakinra
Placebo
Significant decrease ▼
NNT = 1
Significant decrease in recurrent pericarditis (18.2% vs. 90%; ARD -71.8, 95% CI -100 to -42)
Safety outcomes
Significant difference in transient local skin reactions (95.2% vs. 0).
Conclusion
In patients with recurrent pericarditis with ≥ 3 previous recurrences, CRP elevation, colchicine resistance, and corticosteroid dependence received anakinra at a dose of 2 mg/kg/day, up to 100 mg, for 6 months (or until a pericarditis recurrence) after an initial 2-month treatment with anakinra, anakinra was superior to placebo with respect to recurrent pericarditis.
Reference
Brucato A, Imazio M, Gattorno M et al. Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence: The AIRTRIP Randomized Clinical Trial. JAMA. 2016 Nov 8;316(18):1906-1912.
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