Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence: The Anakinra-Treatment of Recurrent Idiopathic Pericarditis (AIRTRIP) Randomized Clinical Trial
Primary result · Recurrent pericarditisResult — go to the resultIncidence rate difference −1.95 % 95% CI −3.3% to −0.6%Authors' conclusion
In this preliminary study of patients with recurrent pericarditis with colchicine resistance and corticosteroid dependence, the use of anakinra compared with placebo reduced the risk of recurrence over a median of 14 months.
Study context
- Population
- Recurrent pericarditis (≥3 previous recurrences) with elevated C-reactive protein, colchicine resistance and corticosteroid dependence
- Participants
- 21 participants
- Comparison
- Anakinra vs placebo
- Anakinran = 11
- Placebon = 10reference
- Primary endpoint
- Recurrent pericarditis and time to recurrence after randomization
Methodological detailsdouble-blind, placebo-controlled, randomized withdrawal, 3 Italian referral centres, Enrolled June–November 2014; follow-up to October 2015, Open-label anakinra for 2 months, responders randomized for 6 months or until recurrence
- Double-blind
- Placebo-controlled
- Randomized withdrawal
- 3 Italian referral centres
- Enrolled June–November 2014; follow-up to October 2015
- Open-label anakinra for 2 months, responders randomized for 6 months or until recurrence
Primary result
Recurrent pericarditis · median follow-up 14 months
Incidence rate difference
−1.95 %
95% CI −3.3% to −0.6%
Events by treatment group
Anakinravs Placebo
incidence rate difference −1.95 % (95% CI −3.3% to −0.6%)
As reported in the abstract
Safety
| Outcome | Anakinra |
|---|---|
| AEs during anakinra treatment | |
| Transient local skin reactions | 20 of 21 (95.2%) |
| Herpes zoster | 1 (4.8%) |
| Transaminase elevation | 3 (14.3%) |
| Ischemic optic neuropathy | 1 (4.8%) |
- AEs during anakinra treatment: anakinra AEs counted over all 21 patients treated with anakinra
AEs during anakinra treatment
- No patient permanently discontinued the active drug
Original publication
Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence: The AIRTRIP Randomized Clinical Trial. JAMA. Published 8 November 2016. doi:10.
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