Pregnancy outcomes after exposure to tocilizumab: A retrospective analysis of 61 patients in Japan

Abstract

Objectives: To assess the effects of tocilizumab on pregnancy outcomes in Japanese patients with rheumatic disease. Methods: Data from Chugai’s tocilizumab safety database (April 2005 to October 2014) were retrospectively analyzed to identify pregnancy outcomes in patients exposed to tocilizumab. Results: Data were available for 61 pregnancies exposed to tocilizumab, and outcomes were reported for 50 of those pregnancies. In 36 births, no congenital anomalies were identified; however, six neonatal abnormalities were reported: five cases of low birth weight (<2500 g) and one case of neonatal asphyxia. Of 36 births, tocilizumab was resumed during lactation in two patients, with no subsequent adverse events reported in newborns. The spontaneous abortion rate was 18.0% (9 of 50 pregnancies), which is comparable to the rate in the general population. The five terminated pregnancies included one case of caudal regression syndrome. Conclusions: The present retrospective study of 61 pregnancies exposed to tocilizumab at conception indicated no increased rates of spontaneous abortion or congenital abnormalities in patients with rheumatic disease. However, further study is necessary to confirm the benefit-risk profile of tocilizumab treatment during pregnancy.

A successful pregnancy in a patient with Takayasu's arteritis under tocilizumab treatment: A longitudinal case study

“…In another research, Nakajima et al presented research outcomes on 50 pregnant patients who used TCZ during conception, pregnancy or lactation and TCZ was continued during lactation in two patients, and no adverse events were reported in new‐born infants. Their findings revealed that the rates of natural abortion, congenital abnormalities, and other pregnancy outcomes were similar to those seen in the general population in the previous studies …”

“…Their findings revealed that the rates of natural abortion, congenital abnormalities, and other pregnancy outcomes were similar to those seen in the general population in the previous studies. 15,16 To our knowledge, there is no research that showed a case of pregnancy in a patient with TA diagnosis who was on TCZ treatment and had healthy delivery. We present a case of pregnancy in a patient with TA diagnosis who was on TCZ treatment, followed up for 12 years and had a healthy delivery outcome.…”

“…and azathioprine was initiated again due to the activation. The patient, whose prednisolone dose could not be reduced below 15 Tocilizumab is a biologic agent which is approved for RA patients.…”

IL-6 inhibitor for the treatment of rheumatoid arthritis: A comprehensive review

“…In an analysis of global pregnancyrelated reports, an increased preterm birth rate was observed [117]. In Japan, the spontaneous abortion rate of TCZexposed women is comparable to the rate in the general population [118]. Both reports demonstrated no indication of a substantially increased malformation risk [117,118].…”

Challenges and treatment options for rheumatoid arthritis during pregnancy

“…Several case reports and case series have been published in the last years, for a total of 122 pregnancies early exposed to TCZ. As a whole, these publications report a very low rate of congenital malformations (1-4%), but a relevant risk of spontaneous abortion (about 20%) [92][93][94][95][96][97].…”