scholarly journals Pegloticase immunogenicity: the relationship between efficacy and antibody development in patients treated for refractory chronic gout

2014 ◽  
Vol 16 (2) ◽  
pp. R60 ◽  
Author(s):  
Peter E Lipsky ◽  
Leonard H Calabrese ◽  
Arthur Kavanaugh ◽  
John S Sundy ◽  
David Wright ◽  
...  



2012 ◽  
Vol 39 (7) ◽  
pp. 1450-1457 ◽  
Author(s):  
VIBEKE STRAND ◽  
DINESH KHANNA ◽  
JASVINDER A. SINGH ◽  
ANNA FORSYTHE ◽  
N. LAWRENCE EDWARDS

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.





2012 ◽  
Vol 15 (4) ◽  
pp. A39-A40
Author(s):  
B.C.M. Wang ◽  
L. Garrison


2012 ◽  
Vol 48 (7) ◽  
pp. 441 ◽  
Author(s):  
R.L. George ◽  
J.S. Sundy


2013 ◽  
Vol 29 (6) ◽  
pp. 155-160
Author(s):  
Katherine A. Lyseng-Williamson


1967 ◽  
Vol 31 ◽  
pp. 239-251 ◽  
Author(s):  
F. J. Kerr

A review is given of information on the galactic-centre region obtained from recent observations of the 21-cm line from neutral hydrogen, the 18-cm group of OH lines, a hydrogen recombination line at 6 cm wavelength, and the continuum emission from ionized hydrogen.Both inward and outward motions are important in this region, in addition to rotation. Several types of observation indicate the presence of material in features inclined to the galactic plane. The relationship between the H and OH concentrations is not yet clear, but a rough picture of the central region can be proposed.



Paleobiology ◽  
1980 ◽  
Vol 6 (02) ◽  
pp. 146-160 ◽  
Author(s):  
William A. Oliver

The Mesozoic-Cenozoic coral Order Scleractinia has been suggested to have originated or evolved (1) by direct descent from the Paleozoic Order Rugosa or (2) by the development of a skeleton in members of one of the anemone groups that probably have existed throughout Phanerozoic time. In spite of much work on the subject, advocates of the direct descent hypothesis have failed to find convincing evidence of this relationship. Critical points are:(1) Rugosan septal insertion is serial; Scleractinian insertion is cyclic; no intermediate stages have been demonstrated. Apparent intermediates are Scleractinia having bilateral cyclic insertion or teratological Rugosa.(2) There is convincing evidence that the skeletons of many Rugosa were calcitic and none are known to be or to have been aragonitic. In contrast, the skeletons of all living Scleractinia are aragonitic and there is evidence that fossil Scleractinia were aragonitic also. The mineralogic difference is almost certainly due to intrinsic biologic factors.(3) No early Triassic corals of either group are known. This fact is not compelling (by itself) but is important in connection with points 1 and 2, because, given direct descent, both changes took place during this only stage in the history of the two groups in which there are no known corals.



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