PMID- 23485476
OWN - NLM
STAT- MEDLINE
DCOM- 20130903
LR  - 20220317
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Linking)
VI  - 52
IP  - 7
DP  - 2013 Jul
TI  - Rilonacept for gout flare prevention during initiation of uric acid-lowering 
      therapy: results from the PRESURGE-2 international, phase 3, randomized, 
      placebo-controlled trial.
PG  - 1285-92
LID - 10.1093/rheumatology/ket114 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of IL-1 inhibitor rilonacept (IL-1 
      Trap) for gout flare (GF) prevention during initiation of uric acid-lowering 
      therapy (ULT) with allopurinol in a multiregional phase 3 clinical trial. 
      METHODS: Hyperuricaemic adults (n = 248) from South Africa, Germany and Asia with 
      gout and two or more GFs within the past year were initiated on allopurinol and 
      randomized 1:1:1 to once-weekly s.c. treatment with placebo (PBO), rilonacept 80 
      mg (R80) or rilonacept 160 mg (R160) for 16 weeks. The primary endpoint was the 
      number of GFs per patient through week 16. RESULTS: The population was 
      predominantly male and racially diverse (white, 53.2%; Asian, 33.1%; black, 
      13.7%). Across treatments, most patients completed the study (87.8-92.9%). At 16 
      weeks the mean number of GFs per patient was reduced by 71.3% with R80 (0.35) and 
      by 72.6% with R160 (0.34) relative to PBO (1.23; both P < 0.0001). The proportion 
      of patients without GFs was higher with R80 (74.4%) and R160 (79.5%) than with 
      PBO (43.9%; both P </= 0.0001), and the proportions of patients on rilonacept with 
      multiple GFs were significantly lower (P < 0.001). Overall, the incidence of 
      adverse events (AEs) was similar between PBO (61.0%) and rilonacept (65.1%). 
      Injection site reactions, generally mild, were the most frequent AE with 
      rilonacept (1.2% PBO, 12.2% R80 and 17.9% R160); none of these injection site 
      reactions led to withdrawal. There were no study drug-related serious AEs or 
      deaths. CONCLUSION: Rilonacept significantly reduced the occurrence of GFs 
      associated with initiation of ULT, with >70% of patients having no flares, and 
      demonstrated an acceptable safety and tolerability profile. TRIAL REGISTRATION: 
      ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00958438.
FAU - Mitha, Essack
AU  - Mitha E
AD  - Newtown Clinical Research, Suite 3, Newgate Centre, Jeppe Street, Newtown, 
      Johannesburg, Gauteng, 2113, South Africa. emitha@iburst.co.za
FAU - Schumacher, H Ralph
AU  - Schumacher HR
FAU - Fouche, Leon
AU  - Fouche L
FAU - Luo, Shue-Fen
AU  - Luo SF
FAU - Weinstein, Steven P
AU  - Weinstein SP
FAU - Yancopoulos, George D
AU  - Yancopoulos GD
FAU - Wang, Jian
AU  - Wang J
FAU - King-Davis, Shirletta
AU  - King-Davis S
FAU - Evans, Robert R
AU  - Evans RR
LA  - eng
SI  - ClinicalTrials.gov/NCT00958438
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130313
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (Gout Suppressants)
RN  - 0 (Receptors, Interleukin-1 Type I)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 268B43MJ25 (Uric Acid)
RN  - 63CZ7GJN5I (Allopurinol)
RN  - 8K80YB5GMG (rilonacept)
SB  - IM
MH  - Adult
MH  - Allopurinol/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Gout/blood/*prevention & control
MH  - Gout Suppressants/*therapeutic use
MH  - Humans
MH  - Hyperuricemia/blood/*drug therapy
MH  - Male
MH  - Medication Adherence
MH  - Middle Aged
MH  - Receptors, Interleukin-1 Type I/antagonists & inhibitors
MH  - Recombinant Fusion Proteins/*therapeutic use
MH  - Treatment Outcome
MH  - Uric Acid/blood
OTO - NOTNLM
OT  - biologic therapies
OT  - clinical trials and methods
OT  - crystal arthropathies
OT  - cytokines and inflammatory mediators
OT  - inflammation
EDAT- 2013/03/15 06:00
MHDA- 2013/09/04 06:00
CRDT- 2013/03/15 06:00
PHST- 2013/03/15 06:00 [entrez]
PHST- 2013/03/15 06:00 [pubmed]
PHST- 2013/09/04 06:00 [medline]
AID - ket114 [pii]
AID - 10.1093/rheumatology/ket114 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2013 Jul;52(7):1285-92. doi: 10.1093/rheumatology/ket114. 
      Epub 2013 Mar 13.