D3.362 - Use and safety of canakinumab during pregnancy
Background
Canakinumab is a human recombinant monoclonal antibody against IL-1ß indicated for treatment of selected autoinflammatory periodic fever syndromes. Currently there is only limited data on its use during pregnancy. All currently available data are derived from case reports. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The risk for the foetus/mother is unknown. Currently women who are pregnant or who want to become pregnant should only be treated after a thorough benefit-risk evaluation. Our main aim is to provide more findings about this important topic.
Method
We have collected data from three patients followed and treated in Centre for periodic fevers in University Hospital Martin and concluded retrospective analysis of the collected data.
Results
There were three maternal-exposed pregnancies and no paternal exposure. One patient was diagnosed with mevalonate kinase deficiency, one patient was diagnosed with familiar Mediteranean fever and one patient was diagnosed with TNF-receptor associated periodic syndrome. All patients are treated with canakinumab and all three patients had continued the canakinumab treatment during pregnancy. The diseases were under full control during pregnancy. In two female patients, conception was unsuccessful prior to canakinumab treatment; however, the therapy led to disease control, a reduction in inflammation, and subsequently successful conception. All patients had given birth to three healthy infants. There were no reported miscarriages, no complications during pregnancies and no serious infections in newborns. The children have normal developement, there were no reports of developmental delays or chronic ilnesses.
Conclusion
As our data and data available in the literature have shown, there are currently no reported harmful effects of canakinumab during pregnancy. Because of the scarcity of the data, the use of canakinumab during pregnancy should be carefully managed and women who want to become pregnant should only continue the treatment after thorough benefit-risk evaluation.
