PMID- 19248129
OWN - NLM
STAT- MEDLINE
DCOM- 20090526
LR  - 20240109
IS  - 0004-3591 (Print)
IS  - 0004-3591 (Linking)
VI  - 61
IP  - 3
DP  - 2009 Mar 15
TI  - Intraarticular injection of anakinra in osteoarthritis of the knee: a 
      multicenter, randomized, double-blind, placebo-controlled study.
PG  - 344-52
LID - 10.1002/art.24096 [doi]
AB  - OBJECTIVE: To evaluate the clinical response, safety, and tolerability of a 
      single intraarticular injection of anakinra in patients with symptomatic 
      osteoarthritis (OA) of the knee. METHODS: Patients with OA of the knee were 
      enrolled in a multicenter, double-blind, placebo-controlled study and randomized 
      2:1:2 to receive a single intraarticular injection of placebo, anakinra 50 mg, or 
      anakinra 150 mg in their symptomatic knee. Patients were evaluated for 12 weeks 
      postinjection. The primary end point was the change in the Western Ontario and 
      McMaster Universities Osteoarthritis Index (WOMAC) score from baseline to week 4. 
      Safety assessments included the evaluation of adverse events (AEs), laboratory 
      tests, and vital signs. Pharmacokinetic parameters were assessed in a subset of 
      patients. RESULTS: Of 170 patients who enrolled, 160 (94%) completed the study. 
      The mean improvements from baseline to week 4 in the WOMAC score were not 
      statistically different between the placebo group and the patients who received 
      50 mg of anakinra (P = 0.67) or 150 mg of anakinra (P = 0.77). Anakinra was well 
      tolerated. No withdrawals due to AEs or serious AEs, and no serious infections or 
      deaths were reported. No clinically significant trends were noted in laboratory 
      values or vital signs. Pharmacokinetic parameters demonstrated that the mean 
      terminal half-life of anakinra in serum after intraarticular injection was 
      approximately 4 hours. CONCLUSION: Anakinra was well tolerated as a single 50-mg 
      or 150-mg intraarticular injection in patients with OA of the knee. However, 
      anakinra was not associated with improvements in OA symptoms compared with 
      placebo.
FAU - Chevalier, X
AU  - Chevalier X
AD  - Department of Rheumatology, Hospital Henri Mondor, University Paris XII, Creteil, 
      France. xavier.chevalier@hmn.ap-hop-paris.fr
FAU - Goupille, P
AU  - Goupille P
FAU - Beaulieu, A D
AU  - Beaulieu AD
FAU - Burch, F X
AU  - Burch FX
FAU - Bensen, W G
AU  - Bensen WG
FAU - Conrozier, T
AU  - Conrozier T
FAU - Loeuille, D
AU  - Loeuille D
FAU - Kivitz, A J
AU  - Kivitz AJ
FAU - Silver, D
AU  - Silver D
FAU - Appleton, B E
AU  - Appleton BE
LA  - eng
SI  - ClinicalTrials.gov/NCT00110916
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Rheum
JT  - Arthritis and rheumatism
JID - 0370605
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Interleukin 1 Receptor Antagonist Protein)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antirheumatic Agents/*administration & dosage/adverse effects/pharmacokinetics
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Injections, Intra-Articular
MH  - Interleukin 1 Receptor Antagonist Protein/*administration & dosage/adverse 
      effects/pharmacokinetics
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis, Knee/*drug therapy
MH  - Severity of Illness Index
EDAT- 2009/02/28 09:00
MHDA- 2009/05/27 09:00
CRDT- 2009/02/28 09:00
PHST- 2009/02/28 09:00 [entrez]
PHST- 2009/02/28 09:00 [pubmed]
PHST- 2009/05/27 09:00 [medline]
AID - 10.1002/art.24096 [doi]
PST - ppublish
SO  - Arthritis Rheum. 2009 Mar 15;61(3):344-52. doi: 10.1002/art.24096.