Results
tuberculosis, Dressler syndrome, pain, pericarditis, effusion
RECURRENCES, RECURRENCE, ADVERSE EVENTS, DISEASE, TUBERCULOSIS, DRESSLER SYNDROME, PERICARDIAL EFFUSION, PERICARDITIS, EFFUSION
Eighty-six patients enrolled in the trial and participated in the run-in. Mean (SD) total number of prestudy recurrences, including index and qualifying episodes, was 4.7 (1.7). Mean (SD) duration of disease was 2.4 (3.1) years and mean (SD) duration of prior glucocorticoid treatment was 19.9 (36.3) weeks.Of 86 enrolled patients, 79 were receiving background therapy at baseline. Of these 79 patients, 74 achieved rilonacept monotherapy. The 5 patients not achieving rilonacept monotherapy did not have pericarditis recurrence; discontinuation was due to adverse events (n=3), positive result on tuberculosis testing (n=1), and sponsor decision (n=1).Demographic and clinical characteristics of the patients receiving double or triple combination treatment for recurrent pericarditis at baseline*Race was reported by patient.†The cause of the Dressler syndrome was catheter ablation for atrial fibrillation.‡Scores on the Numerical Rating Scale for pain range from 0 to 10, with higher scores indicating greater pain severity.§Pericardial effusion was defined as new or worsening pericardial effusion, independent of the imaging method.¶Non-steroidal anti-inflammatory drugs.Despite the protocol-specified requirement that patients reach monotherapy rilonacept by week 10 to qualify for randomisation (after 2 weeks of monotherapy), median time to rilonacept monotherapy ranged from 7.1 weeks to 8.1 weeks for patients in the three groups (NSAID plus colchicine and glucocorticoid; colchicine plus glucocorticoid; NSAID plus colchicine; Median time to rilonacept monotherapy, by therapy combination at baseline. GC, glucocorticoid; NSAID, non-steroidal anti-inflammatory drug.Patients receiving both colchicine and glucocorticoids (n=31) were transitioned from background therapies in similar proportions either sequentially (n=14, 45.2%) or concurrently (n=17, 54.8%). Regardless of taper approach, investigators transitioned all patients to rilonacept monotherapy within similar timeframes: sequential (n=14; median, (Q1, Q3), 7.7 (6.1, 8.3) weeks) and concurrent (n=17; median (Q1, Q3), 8.0 (7.1,10.0) weeks) (Median time to rilonacept monotherapy in patients receiving treatment with colchicine and glucocorticoids at baseline, by taper approach. GC, glucocorticoid; NSAID, non-steroidal anti-inflammatory drug.Representative approaches to tapering NSAIDs, colchicine and glucocorticoids. Because these data represent weekly average doses, some data points do not reach zero at the final tapering time point; however, complete taper was achieved. GC, glucocorticoid; NSAID, non-steroidal anti-inflammatory drug; RI, run-in.A trend was observed towards shorter median time to monotherapy in patients with a prestudy annualised incidence of fewer than two episodes per year (median, 6.1 (Q1–Q3, 4.1–8.1) weeks; n=23) than in patients with 2–4 episodes per year (median, 8.3 (Q1–Q3, 7.0–10.0) weeks; n=23) or in those with more than four episodes per year (median, 8.1 (Q1–Q3, 6.6–9.9); n=28). A trend was also observed towards shorter median time to monotherapy in patients with disease duration longer than 2 years (median, 6.1 (Q1–Q3, 4.3–9.3) weeks; n=25) than in patients with disease duration of 1–2 years (median, 8.0 (Q1–Q3, 6.1–9.7) weeks; n=26) or less than 1 year (median, 8.0 (Q1–Q3, 6.7–10.0) weeks; n=23).