Monday, 29 August 2016

Pregnancy and Natalizumab

Friend S, Richman S, Bloomgren G, Cristiano LM, Wenten M.
Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study.BMC Neurol. 2016 Aug 24;16(1):150. doi: 10.1186/s12883-016-0674-4.



BACKGROUND: Patients with multiple sclerosis (MS) or Crohn's disease (CD) being treated with natalizumab (Tysabri®, Biogen) who are planning to become pregnant or discover they are pregnant after exposure to natalizumab are currently advised to balance the potential benefits and potential risks of exposure when considering treatment options. This study was undertaken to evaluate pregnancy outcomes of women with MS or CD who were exposed to natalizumab at any time within 3 months prior to conception or during pregnancy. A pregnancy registry was created to better understand the effect of natalizumab exposure on pregnancy outcomes.
METHODS:The Tysabri Pregnancy Exposure Registry was a global, observational exposure registration and follow-up study. Evaluations included spontaneous abortions (<22 weeks gestational age), fetal losses (≥22 weeks gestational age), ectopic pregnancies, elective or therapeutic terminations, stillbirths, birth defects, and live births. Birth defects were reviewed and coded in accordance with the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of birth defects.
RESULTS:A total of 369 patients with MS and 7 patients with CD were enrolled, of whom 355 patients (99.4 %; 349 MS and 6 CD) had known pregnancy outcomes (including 8 twin sets). The spontaneous abortion rate was 9.0 % (n = 32; 95 % confidence interval [C. I.], 6.3-12.5 %). An independent advisory committee review determined the major birth defect rate to be 5.05 % (16 of 316 live births + 1 elective abortion; 95 % C. I., 2.9-8.1 %). The mean gestational age of the live-born infants was 38.3 weeks, and the mean birth weight was 3158.3 g.
CONCLUSIONS: Although the overall rate of birth defects was higher than that observed by the MACDP, these registry outcomes showed no specific pattern of malformations that would suggest a drug effect, and the spontaneous abortion rate was consistent with that of the general population.
If you are planning to start a family make sure that you consult with your MS team for advice and monitioring of your treatment status

4 comments:

  1. Would someone like to reassure people that Tysabri is not guarantee of death? The totally medically unqualified Joan Beal has ranted on her Facebook page ccsvi in multiple sclerosis that it should be withdrawn (again). Is a well-supported drug more dangerous than havin your veins stretched by an arterial specialist?

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    Replies
    1. The world is full of tysabrians who are alive and kicking...

      As to Joan...we best not say too much as the CCSVI spies on the blog will be writing on their facebook pages:-).

      Back in the days before the New World Order when the meecies could and would play, our Joanie waxed lyrical about ProfG and prompting the lab to buy her latest Sweet Dreams EP for profG.

      We had have a picture on the blog somewhere.

      Prog(Ali)G "Is you with the CCSV?"
      Joan Beal "I"

      https://lh3.googleusercontent.com/-RW-gIq-2A58/T5VbQW5UPOI/AAAAAAAAA98/a2iDAL2hBZQeq1372d9d5Sy-sg6b11iGQCEw/w140-h110-p/Prof%2BG.jpg

      We know the answer about the question and the veins being stretched is not a supported treatment that is based on hard fact, the well-supported drug is.

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    2. Maybe not for MS BUT it is some kind of condition...otherwise why would it be in latest Oxford Textbook of Vascular Surgery ?

      Section 10 - Diseases of the veins and lymphatics
      10.8. Chronic cerebro-spinal venous insufficiency, Paolo Zamboni, Sergio Gianesini and Erica Menegatti
      https://global.oup.com/academic/product/oxford-textbook-of-vascular-surgery-9780199658220?cc=us&lang=en&#

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    3. No idea why..[erhaps they asked Paolo Zamboni to write a chapter, if they had asked Sam Allardyce maybe you would have a chapter on the Engalnd first XI

      Delete

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