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  • SF-36 physical component summary: N?N�?�?????� ??N�????N????� ??N� ???�N�????????N�?? ???????? ???� N??�??????N�?� 12: +9.07, +8.13 N???N�N????? +2.36 ?�?� 200 mg ???� ??N??�???? 2 N??�??????N�?? ?? 400 mg ???� ??N??�???? 4 N??�??????N�?? certolizumab pegol N???N�N????? placebo
  • SF-36 mental component summary: N?N�?�?????� ??N�????N????� ??N� ???�N�????????N�?? ???????? ???� N??�??????N�?� 12: +3.32, +4.08 N???N�N????? +1.22 ?�?� 200 mg ???� ??N??�???? 2 N??�??????N�?? ?? 400 mg ???� ??N??�???? 4 N??�??????N�?? certolizumab pegol N???N�N????? placebo
  • AS Quality of Life: N?N�?�?????� ??N�????N????� ??N� ???�N�????????N�?? ???????? ???� N??�??????N�?� 12: -4.59, -4.17 N???N�N????? -1.31 ?�?� 200 mg ???� ??N??�???? 2 N??�??????N�?? ?? 400 mg ???� ??N??�???? 4 N??�??????N�?? certolizumab pegol N???N�N????? placebo

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?�?�?�??N�??????N�?�???� ???� N�?�???�N�??N� B ???�N?N�NS?????� ??N�?? ???�N�???�??N�??, ??N�???�???�N�?? TNF ?�??N�?�????????N?N�, ?????�NZN�??N�?�?�???? certolizumab pegol, ??????N�?? N??� N�N�??????N�???? ????N???N�?�?�?? ???� N�???�?? ????N�N?N? (N�.?�. ?????�??N�???????? ?�?� ??????NSN�N�????N?N�?�?? ?�??N�?????�??). ??N??????? N??�N?N�?�?? N??� ?�?�??NSN�N????�?? N�?�N�?�?�????. ?Y?�N�???�??N�??N�?� N�N�N??�???� ???� ?�NS???�N� ???�N??�?�?????�???? ?�?� HBV ????N�?�??N�??N? ??N�?�???? ?�?�????N�???�???� ???� ?�?�N�?�?????� N? certolizumab pegol. ????N???N�?�?�??N�?� ???� HBV, ??????N�?? N??� ??N??�???�N?N� ??N� ?�?�N�?�?????� N? certolizumab pegol, N�N�N??�???� ???� ?�NS???�N� N�?�?????????? ??N�??N??�?�??N????�???? ?�?� ??N�???�???�N�?? ?? N???????N�?????? ???� ?�??N�???????� HBV ????N�?�??N�??N? ???? ??N�?�???� ???� ?�?�N�?�?????�N�?? ?? ??N??????�???? ???�N??�N�?� N??�?�?? ???�????????N�?? ??N�?�N?N?N�?�??????N????�???�. ?Y?�N�???�??N�??, ??N�?? ??????N�?? N??� ??N�??N???N????� N�?�?�??N�??????N�?�???� ???� HBV, certolizumab pegol N�N�N??�???� ???� ?�NS???� N???N�N????� ?? N�N�N??�???� ???� N??� ?�?�????N�???� ?�N�?�??N�???????� ?�??N�??-????N�N?N????� N�?�N�?�????N? N? ??????N�????N?N�?? ????????NSN�?�?�N�?? ?�?�N�?�?????�. ??????N�N�?�?�?�N�?� ???� TNF ?�??N�?�????????N?N�??, ?????�NZN�??N�?�?�???? certolizumab pegol ?????�?� ???� N????�?�??N�?? N�??N????� ??N� ????N????� ???�?? ???�??N?N�N�N????� ???� ???�??????N�????N�?� N???????N�?????? ??/???�?? N�?�??N�???�??????N�?�N�N????? ???�?????? ?�?� ???�?????�?�???????�??N�?�N�?? ?�?�?�???�N????�???�; ???�N�?�?�N????�???� ???� ?�??N�????N????�?�?�N�???? ?�??N�??N�?�?�?� ?? ?? N�?�?????? N??�N?N�?�?? ???? ????N????�N�?� ???� ?�N???N?N?-?????????�?�?? N???????N�???? ?? N�?�?�??N�???? ???� N�?�?�???� N???N�NSN�N�N???N?N�????N�?�?�????N?N�. ?????? ???�N�???�??N� N�?�?�?????� ??N?????N? ??N� N�?�?�?? N�?�?�??N�???? ??N�???�???�?�?????�N�?? ???� certolizumab pegol N�N�N??�???� ???� ?�NS???� ???�?�?�?�?�?????? ??N�?�N?N?N�?�???????�???? ?? ?�NS???� ???�?�???�N�?�???? ??????N�????N?N�?? ?�?�N�?�?????�. ??NS???�?�N????? N?NS??N�?�???�??????N�?� ?�???�????N? ???�N�??N?N�????N?N� N�??N??? ??N� N�?�?�????N�???�N�?? ???� ?�????N�????, ?�?�?????�????N? ???�?? ??N�N????? ?�?�?????�N�?�N?N�???�???? ?�?�?�???�N????�????N? ??N�?? ???�N�???�??N�??N�?� ???� ?�?�N�?�?????� N? TNF ?�??N�?�????????N?N� ???� ?????�?� ???� ?�NS???� ???�???�NZN�?�??. ?YN�?? ???�N�???�??N�??, ?�?�??N????�???? N? certolizumab pegol, N??� N?NS???�N�?�???�???? N�?�?????? N??�N?N�?�?? ???� ???�??N�???�??????N�???? ???�N�N?N??�????N?, ?????�NZN�??N�?�?�???? ??N�?????�??NSN�??, ???�??N�??N� ?? ???�N�??N�?�N�???� ???�??N�?????�N�??N?. ???�?�?�?�?�???? N�?�?�??N�???? ??N� N?N�N�?�???� ???� ??N�NS??N�?�, ?????�NZN�??N�?�?�???? ???�??????N�???? ?�???�N�?????� N�??N�?????�????N? N??� N?NS???�N�?�???�???? ??N�?? certolizumab pegol. ?�N???N�???? ???�N�???�??N�?? N�N�N??�???� ???� ?�NS???�N� ????N?NS???�N�???�???? ???� N�NSN�N?N?N� ???�?�?�?�?�?????� ?�?�???�N�N????� ????????N� ??N�?? ????N????�N�?� ???� ??N�???�???�N�?? ?? N???????N�??????, ??N�?�???????�?�???�N�?? ??N�NS?????� ????N???N�?�?�??N? ???�?? ????N�?�??N�??N? (???�??N�. ???�N�N???N?N�??N�?�N�?� N�N�?�N????�, ???�N�NSN�N�???�???�, ??NSN�???�???�, ?�?�?�????N?N�) ???? ??N�?�???� ???� ?�?�N�?�?????�N�?? N? certolizumab pegol. ??N�N??�???� ???� ?�NS???� ???�????N??�?�???? ??N�?�N?N?N�?�??????N????�???� ???� ?�?�N�?�?????�N�?? N? certolizumab pegol ??N�?? ???�N�???�??N�?? N? ????N�??NSN�???�???? ?�???�N�?????? N�?�???�N�???�??????N�???? ???�N�N?N??�????N?. ???� N??� ??N�?�????N�NSN�???� ???????�??????N�?�???� ???� certolizumab pegol N? anakinra ???�?? abatacept ????N�?�???? ????N�?�??N�???�?�?�?? N????�?�??N�?�?? N�??N??? ??N� N�?�?�???? ????N�?�??N�????.

??NS?? ???�N�?? ??N????� ???�?�??N�???? ???�??????, certolizumab pegol ???� N�N�N??�???� ???� ?�NS???� ??N�???�?�???�?? ?�????????N�?�???�?????? N? ?�?????? ???�??N???????. 14-?????�??????N?N� ?????�N??�??????N� ???� certolizumab pegol N�N�N??�???� ???� N??� ?????� ??N�?�????????, ?�???? ?� ???�?�????N�?�???� N�??N�N?N�????N�???� ???�???�N??�. ?Y?�N�???�??N�, ???�??N??????�N� N�??N�N?N�????N�???� ???�???�N??�, ???????�N�?? ??N�???�???� certolizumab pegol, N�N�N??�???� ???� ?�NS???� N�?�?????????? ??N�??N??�?�??N????�?? ?�?� ????N�?�??N�????.

?????�N?, ?�?�?????�???�??N�?� N??� N? ??NS?�???�N�?� ????N�??N�???�N�??N? ?�?� ??N�?�??????N????�???� ???� ??N�????N???N�?� ???? ??N�????N??�?????� ???� ??N�N?????N�?� ???�?�?�?�?�???? ?�N�?�??N�??, ??NS?�????N? ??N�??N�???� ???� ?�?�?�?????�N?????N?N� ?? ??N?N�?�???�?�?�N�?� ????N�??N�???�N�??N?N�?� ?�?� ??N�?�??????N????�???�. ?�?�N�?� ???� ?�??N�N??�?�???�??N�?�???� ???� ?�??N�?????�??N????�N�?� ?s???Y – NZ???? 2012.

http://www.ema.europa.eu/docs/bg_BG/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf

References

  1. Abstract Number 777: Landewe R., Rudwaleit M., van der Heijde D. et al. Effect of certolizumab pegol on signs and symptoms of ankylosing spondylitis and non-radiographic axial spondyloarthritis: 24 week results of a double blind randomized placebo-controlled phase 3 axial spondyloarthritis study. Presented at the Annual Scientific Meeting of the American College of Rheumatology (ACR) 2012.
  2. Abstract Number 1372: Van der Heijde D., Braun J., Rudwaleit M. et al. Improvements in productivity at paid work and within household and increased Participation in Daily Activities After 24 Weeks of Certolizumab Pegol Treatment of Axial Spondyloarthritis Patients, Including Patients with Ankylosing Spondylitis: Results of a Phase 3 Double-Blind Randomized Placebo-Controlled Study. Presented at the Annual Scientific Meeting of the American College of Rheumatology (ACR) 2012.
  3. Abstract Number 558: Sieper J., Kivitz A., van Tubergen A. et al. Rapid improvements in patient reported outcomes with certolizumab pegol in patients with axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis: 24 week results of a phase 3 double blind randomized placebo-controlled study. Presented at the Annual Scientific Meeting of the American College of Rheumatology (ACR) 2012.
  4. Abstract Number 1705: Van der Heijde D., Maksymowych W., Landewe R. et al. Effect of certolizumab pegol on inflammation of spine and sacroiliac joints in patients with axial spondyloarthritis: 12 week magnetic resonance imaging results of a phase 3 double blind randomized placebo-controlled study. Presented at the Annual Scientific Meeting of the American College of Rheumatology (ACR) 2012.
  5. UCB Data on file
  6. CimziaA� EU Summary of Product Characteristics. Accessed October 10th 2012 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf
  7. Guideline on Clinical Investigation of Medicinal Products for the Treatment of Ankylosing Spondylitis, European Medicines Agency. Accessed August 24th 2012 from www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003424
  8. Ankylosing Spondylitis, NHS Choices. Accessed August 24th 2012 from http://www.nhs.uk/conditions/Ankylosing-spondylitis/Pages/Introduction.aspx
  9. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis, Assessment of Spondyloarthritis International Society. Accessed August 24th 2012 from http://www.asas-group.org/education.php?id=01

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