PMID- 22660805
OWN - NLM
STAT- MEDLINE
DCOM- 20121126
LR  - 20220330
IS  - 1499-2752 (Electronic)
IS  - 0315-162X (Linking)
VI  - 39
IP  - 7
DP  - 2012 Jul
TI  - Improved health-related quality of life and physical function in patients with 
      refractory chronic gout following treatment with pegloticase: evidence from phase 
      III randomized controlled trials.
PG  - 1450-7
LID - 10.3899/jrheum.111375 [doi]
AB  - OBJECTIVE: To assess the efficacy of pegloticase on pain, physical function, and 
      health-related quality of life (HRQOL) in patients with refractory chronic gout. 
      METHODS: Subjects in 2 replicate, 6-month, randomized controlled phase III trials 
      received intravenous infusions of pegloticase 8 mg twice monthly (biweekly 
      group), pegloticase alternating with placebo (8-mg monthly group), or placebo. 
      Medical Outcomes Study Short Form-36 (SF-36), Health Assessment 
      Questionnaire-Disability Index (HAQ-DI), patient global assessment of disease 
      activity (PtGA), and pain by visual analog scale were completed at weeks 1 
      (baseline), 13, 19, and 25. Prespecified pooled analyses of patient-reported 
      outcomes were performed by combining values for each treatment group (biweekly 
      treatment, monthly treatment, and placebo) at Week 25. RESULTS: Of 212 patients 
      enrolled, 157 (74.1%) completed treatment. At entry, mean age was 55.4 years 
      (range 23-89 yrs) and mean plasma uric acid was 9.7 mg/dl; most were male (81.6%) 
      and white (67.5%). Subjects reported an average of 9.8 flares in the previous 18 
      months. Baseline SF-36 physical component summary (PCS) scores were > 1.5 SD 
      below US normative values. At Week 25, mean changes from baseline in PtGA, pain, 
      HAQ-DI, and PCS scores were statistically significant and exceeded minimum 
      clinically important differences (MCID) in the biweekly treatment group, compared 
      with little to no improvement in placebo group. Statistically significant 
      improvements greater than or equal to MCID were reported in 6 of 8 SF-36 domains. 
      Monthly pegloticase resulted in significantly improved PtGA, HAQ-DI, PCS, and 3 
      SF-36 domains. CONCLUSION: Pegloticase therapy resulted in statistically 
      significant and clinically meaningful improvements in PtGA, pain, physical 
      function, and HRQOL.
FAU - Strand, Vibeke
AU  - Strand V
AD  - Division of Immunology and Rheumatology, Stanford University School of Medicine, 
      306 Ramona Road, Portola Valley, CA 94028, USA. vstrand@stanford.edu
FAU - Khanna, Dinesh
AU  - Khanna D
FAU - Singh, Jasvinder A
AU  - Singh JA
FAU - Forsythe, Anna
AU  - Forsythe A
FAU - Edwards, N Lawrence
AU  - Edwards NL
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120601
PL  - Canada
TA  - J Rheumatol
JT  - The Journal of rheumatology
JID - 7501984
RN  - 0 (Gout Suppressants)
RN  - 268B43MJ25 (Uric Acid)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - EC 1.7.3.3 (Urate Oxidase)
RN  - R581OT55EA (Pegloticase)
SB  - IM
CIN - J Rheumatol. 2012 Jul;39(7):1311-3. doi: 10.3899/jrheum.120427. PMID: 22753797
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Chronic Disease
MH  - Female
MH  - Gout/*drug therapy
MH  - Gout Suppressants/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain/drug therapy
MH  - Pain Measurement
MH  - *Physical Fitness
MH  - Polyethylene Glycols/*therapeutic use
MH  - *Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Urate Oxidase/*therapeutic use
MH  - Uric Acid/blood
MH  - Young Adult
EDAT- 2012/06/05 06:00
MHDA- 2012/12/10 06:00
CRDT- 2012/06/05 06:00
PHST- 2012/06/05 06:00 [entrez]
PHST- 2012/06/05 06:00 [pubmed]
PHST- 2012/12/10 06:00 [medline]
AID - jrheum.111375 [pii]
AID - 10.3899/jrheum.111375 [doi]
PST - ppublish
SO  - J Rheumatol. 2012 Jul;39(7):1450-7. doi: 10.3899/jrheum.111375. Epub 2012 Jun 1.