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CATEGORIES:MRC Biostatistics Unit Seminars
SUMMARY:The Natural History and Predictive Factors of Long
  Term Outcomes in Systemic Lupus Erythematosus:  A
 nalysis from the Hopkins Lupus Cohort - Penny Wats
 on\, School of Health and Related Research\, The U
 niversity of Sheffield
DTSTART;TZID=Europe/London:20110614T143000
DTEND;TZID=Europe/London:20110614T153000
UID:TALK30835AThttp://talks.cam.ac.uk
URL:http://talks.cam.ac.uk/talk/index/30835
DESCRIPTION:Introduction\n\nDecision makers across the world u
 se evidence of treatment benefit from different so
 urces to decide the coverage of new treatments. Th
 ere is a pipeline of new treatments for SLE in cli
 nical trials and recently completed Phase III tria
 ls. Therefore\, there is a need for data to inform
  longer term effectiveness and cost-effectiveness 
 analyses in SLE for decision-making.\n\nObjective\
 n\nTo develop a natural history model to simulate 
 long-term outcomes in Systemic Lupus Erythematosus
  (SLE).\n\nMethods\n\nLongitudinal data on 1354 pa
 tients from the Hopkins Lupus Cohort were included
  in the analysis. Disease activity\, treatments\, 
 Systemic Lupus International Collaborative Clinics
 /American College of Rheumatology Damage Index (SL
 ICC/ACR DI) events\, and laboratory tests are repo
 rted at every clinic visit. A linear random effect
 s model was used to estimate mean change in SLE Di
 sease Activity Index (SLEDAI) score over a year an
 d to estimate average prednisone dose as a functio
 n of SLEDAI score. Parametric survival models were
  used to estimate organ damage and mortality. A si
 mulation model combined the separate statistical m
 odels to assess the validity of the natural histor
 y predictions.\n\nResults\n\nThe long-term disease
  activity model finds that previous SLEDAI\, previ
 ous renal involvement\, age\, and males predict a 
 reduction in future SLEDAI score. Ethnicity\, anae
 mia\, haematological involvement\, increased DNA b
 inding and low complement in the previous year pre
 dict an increase in disease activity. The annual a
 verage prednisone dose increases for every unit in
 crease in annual average SLEDAI. Adjusted Mean SLE
 DAI was associated with an increased risk of morta
 lity\, cardiovascular\, renal and peripheral vascu
 lar damage. Organ involvement predicted mortality\
 , cardiovascular\, renal\, neuropsychiatric\, pulm
 onary\, gastrointestinal\, ocular and skin damage.
  Corticosteroids increase the risk of gonadal fail
 ure\, diabetes\, cardiovascular\, musculoskeletal\
 , neuropsychiatric\, and gastrointestinal damage. 
 The simulation reproduces some of the patient outc
 omes reported in the Hopkins Lupus cohort with goo
 d accuracy.\n\nConclusion\n\nThe analysis generate
 s a natural history model that can be used to extr
 apolate the long-term effectiveness and cost-effec
 tiveness of treatments for SLE. Alternative modell
 ing methods should be explored to improve the desc
 ription of long term outcomes for future treatment
  assessments\n
LOCATION:Large Seminar Room\, 1st Floor\, Institute of Publ
 ic Health\, University Forvie Site\, Robinson Way\
 , Cambridge
CONTACT:Li Su
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