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Hum. Reprod. Advance Access published online on June 12, 2008
Human Reproduction, doi:10.1093/humrep/den177
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© The Author 2008. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org
The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that: the original authorship is properly and fully attributed: the Journal and Oxford University Press are attributed as the original place of publication with the correct citation details given: if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative word this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org

Anti-TNF-{alpha} treatment for deep endometriosis-associated pain: a randomized placebo-controlled trial

P.R. Koninckx1,2,4, M. Craessaerts1, D. Timmerman1, F. Cornillie3 and S. Kennedy2

1 Department of Obstetrics and Gynaecology, UZ Gasthuisberg, Katholieke Universiteit Leuven, B3000 Leuven, Belgium 2 Nuffield Department of Obstetrics and Gynaecology, John Radcliffe Hospital, University of Oxford, Oxford, UK 3 Centocor BV, Medical Affairs Europe, Leiden, The Netherlands

4 Correspondence address. E-mail: pkoninckx{at}gmail.com

BACKGROUND: Endometriosis is associated with an inflammatory response. Hence infliximab, an anti-TNF-{alpha} monoclonal antibody, might relieve pain.

METHODS: A randomized placebo-controlled trial was designed with 21 women with severe pain and a rectovaginal nodule of at least 1 cm. After 1 month of observation, three infusions of infliximab (5 mg/kg) or placebo were given. Surgery was performed 3 months later and follow-up continued for 6 months. The primary end-point was pain (dysmenorrhea, deep dyspareunia and non-menstrual pain) rated at each visit by the clinician and on a daily basis by the patient who in addition scored pain by visual analog pain scale and analgesia intake. Secondary end-points included the volume of the endometriotic nodule, pelvic tenderness and the visual appearance of endometriotic lesions at laparoscopy.

RESULTS: Pain severity decreased during the treatment by 30% in both the placebo (P < 0.001) and infliximab groups (P < 0.001). However, no effect of infliximab was observed for any of the outcome measures. After surgery, pain scores decreased in both groups to less than 20% of the initial value.

CONCLUSIONS: Infliximab appears not to affect pain associated with deep endometriosis. Treatment is associated with an important placebo effect. After surgery, pain decreases to less than 20%. Trials registration number ClinicalTrials.gov: NCT00604864 [ClinicalTrials.gov] .

Submitted on January 18, 2008; resubmitted on March 15, 2008; accepted on April 11, 2008.


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