Tocilizumab use in pregnancy: Analysis of a global safety database including data from clinical trials and post-marketing data

Seminars in Arthritis and Rheumatism

Volumn 46, Issue 2, 2016, Pages 238-245

  Hoeltzenbein, Maria ^a   Beck, Evelin ^a   Rajwanshi, Richa ^b   Gøtestam Skorpen, Carina ^c,d,e   Berber, Erhan ^b   Schaefer, Christof ^a   Østensen, Monika ^c,d  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b GENENTECH INC   (United States)

^c TRONDHEIM UNIVERSITY HOSPITAL   (Norway)

^d NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY   (Norway)

^e Child Habilitation Unit   (Norway)

Author keywords

Malformation; Maternal exposure; Pregnancy; Rheumatoid arthritis; Spontaneous abortion; Tocilizumab

Indexed keywords

METHOTREXATE; TOCILIZUMAB; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY;

ADULT; ANGIOFOLLICULAR LYMPH NODE HYPERPLASIA; AORTA ARCH SYNDROME; ARTICLE; CONTROLLED STUDY; DRUG INDICATION; DRUG SAFETY; FEMALE; HUMAN; JUVENILE RHEUMATOID ARTHRITIS; LIVE BIRTH; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MATERNAL EXPOSURE; MOUSE; NEWBORN; NONHUMAN; PREGNANCY; PREGNANCY OUTCOME; PREGNANCY TERMINATION; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSORIATIC ARTHRITIS; RETROSPECTIVE STUDY; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; SPONTANEOUS ABORTION; STILLBIRTH; SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS; SYSTEMIC SCLEROSIS; ABNORMALITIES, DRUG-INDUCED; ADOLESCENT; ADVERSE EFFECTS; ARTHRITIS, RHEUMATOID; COMBINATION DRUG THERAPY; FACTUAL DATABASE; MIDDLE AGED; POSTMARKETING SURVEILLANCE; YOUNG ADULT;

ABNORMALITIES, DRUG-INDUCED; ADOLESCENT; ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DATABASES, FACTUAL; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MATERNAL EXPOSURE; METHOTREXATE; MIDDLE AGED; PREGNANCY; PREGNANCY OUTCOME; PRODUCT SURVEILLANCE, POSTMARKETING; RISK ASSESSMENT; YOUNG ADULT;

EID: 84977618703     PISSN: 00490172     EISSN: 1532866X     Source Type: Journal    
DOI: 10.1016/j.semarthrit.2016.05.004     Document Type: Article

References (31)

1. [1] Nishimoto, N., Kishimoto, T., Humanized antihuman IL-6 receptor antibody, tocilizumab. Handb Exp Pharmacol 181 (2008), 151–160.
2. [2] Genovese, M.C., McKay, J.D., Nasonov, E.L., Mysler, E.F., da Silva, N.A., Alecock, E., et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum 58 (2008), 2968–2980.
3. [3] Kim, G.W., Lee, N.R., Pi, R.H., Lim, Y.S., Lee, Y.M., Lee, J.M., et al. IL-6 inhibitors for treatment of rheumatoid arthritis: past, present, and future. Arch Pharm Res 38 (2015), 575–584.
4. [4] Yamamoto, K., Goto, H., Hirao, K., Nakajima, A., Origasa, H., Tanaka, K., et al. Longterm safety of tocilizumab: results from 3 years of followup postmarketing surveillance of 5573 patients with rheumatoid arthritis in Japan. J Rheumatol 42 (2015), 1368–1375.
5. [5] Jones, G., Sebba, A., Gu, J., Lowenstein, M.B., Calvo, A., Gomez-Reino, J.J., et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis 69 (2010), 88–96.
6. [6] Sakurai, T., Takai, R., Burgin, H., Ishihara, K., Sakamoto, Y., Amano, J., et al. The effects of interleukin-6 signal blockade on fertility, embryo-fetal development, and immunization in vivo. Birth Defects Res B Dev Reprod Toxicol 95 (2012), 304–317.
7. [7] Food and Drug Administration (FDA). Actemra drug approval package. Pharmacology review. 〈http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125276s000TOC.cfm〉 [accessed 28.03.16].
8. [8] Hyrich, K.L., Verstappen, S.M., Biologic therapies and pregnancy: the story so far. Rheumatology (Oxford) 53 (2014), 1377–1385.
9. [9] Villar, J., Cheikh, I.L., Victora, C.G., Ohuma, E.O., Bertino, E., Altman, D.G., et al. International standards for newborn weight, length, and head circumference by gestational age and sex: the Newborn Cross-Sectional Study of the INTERGROWTH-21st Project. Lancet 384 (2014), 857–868.
10. [10] Reed, S.D., Vollan, T.A., Svec, M.A., Pregnancy outcomes in women with rheumatoid arthritis in Washington State. Matern Child Health J 10 (2006), 361–366.
11. [11] World Health Organisation (WHO). Congenital anomalies. 〈http://www.who.int/mediacentre/factsheets/fs370/en/〉 [accessed 2.03.16].
12. [12] European surveillance of congenital anomalies (EUROCAT). Prevalence tables. 〈http://www.eurocat-network.eu/accessprevalencedata/prevalencetable〉 [accessed 28.03.16].
13. [13] Queisser-Luft, A., Stolz, G., Wiesel, A., Schlaefer, K., Spranger, J., Malformations in newborn: results based on 30,940 infants and fetuses from the Mainz congenital birth defect monitoring system (1990–1998). Arch Gynecol Obstet 266 (2002), 163–167.
14. [14] Scheuerle, A., Vannappagari, V.X., Miller, M.K., Measurements of birth defect prevalence: which is most useful as a comparator group for pharmaceutical pregnancy registries?. Birth Defects Res A Clin Mol Teratol 85 (2009), 611–620.
15. [15] Carey, J.C., Martinez, L., Balken, E., Leen-Mitchell, M., Robertson, J., Determination of human teratogenicity by the astute clinician method: review of illustrative agents and a proposal of guidelines. Birth Defects Res A Clin Mol Teratol 85 (2009), 63–68.
16. [16] Weber-Schoendorfer, C., Chambers, C., Wacker, E., Beghin, D., Bernard, N., Shechtman, S., et al. Pregnancy outcome after methotrexate treatment for rheumatic disease prior to or during early pregnancy: a prospective multicenter cohort study. Arthritis Rheumatol 66 (2014), 1101–1110.
17. [17] Borrell, A., Stergiotou, I., Miscarriage in contemporary maternal–fetal medicine: targeting clinical dilemmas. Ultrasound Obstet Gynecol 42 (2013), 491–497.
18. [18] Carrington, B., Sacks, G., Regan, L., Recurrent miscarriage: pathophysiology and outcome. Curr Opin Obstet Gynecol 17 (2005), 591–597.
19. [19] Brouwer, J., Laven, J.S., Hazes, J.M., Dolhain, R.J., Brief report: miscarriages in female rheumatoid arthritis patients: associations with serologic findings, disease activity, and antirheumatic drug treatment. Arthritis Rheumatol 67 (2015), 1738–1743.
20. [20] Wallenius, M., Salvesen, K.A., Daltveit, A.K., Skomsvoll, J.F., Miscarriage and stillbirth in women with rheumatoid arthritis. J Rheumatol 42 (2015), 1570–1572.
21. [21] Martin, J.A., Hamilton, B.E., Sutton, P.D., Ventura, S.J., Mathews, T.J., Osterman, M.J., Births: final data for 2008. Natl Vital Stat Rep 59 (2010), 1, 3–1,71.
22. [22] Wacker, E., Navarro, A., Meister, R., Padberg, S., Weber-Schoendorfer, C., Schaefer, C., Does the average drug exposure in pregnant women affect pregnancy outcome? A comparison of two approaches to estimate the baseline risks of adverse pregnancy outcome. Pharmacoepidemiol Drug Saf 24 (2015), 353–360.
23. [23] Norgaard, M., Larsson, H., Pedersen, L., Granath, F., Askling, J., Kieler, H., et al. Rheumatoid arthritis and birth outcomes: a Danish and Swedish nationwide prevalence study. J Intern Med 268 (2010), 329–337.
24. [24] Langen, E.S., Chakravarty, E.F., Liaquat, M., El-Sayed, Y.Y., Druzin, M.L., High rate of preterm birth in pregnancies complicated by rheumatoid arthritis. Am J Perinatol 31 (2014), 9–14.
25. [25] de Man, Y.A., Hazes, J.M., van der Heide, H., Willemsen, S.P., de Groot, C.J., Steegers, E.A., et al. Association of higher rheumatoid arthritis disease activity during pregnancy with lower birth weight: results of a national prospective study. Arthritis Rheum 60 (2009), 3196–3206.
26. [26] Bowden, A.P., Barrett, J.H., Fallow, W., Silman, A.J., Women with inflammatory polyarthritis have babies of lower birth weight. J Rheumatol 28 (2001), 355–359.
27. [27] Wallenius, M., Salvesen, K.A., Daltveit, A.K., Skomsvoll, J.F., Rheumatoid arthritis and outcomes in first and subsequent births based on data from a national birth registry. Acta Obstet Gynecol Scand 93 (2014), 302–307.
28. [28] Ostensen, M., Cetin, I., Autoimmune connective tissue diseases. Best Pract Res Clin Obstet Gynaecol 29 (2015), 658–670.
29. [29] Bharti, B., Lee, S.J., Lindsay, S.P., Wingard, D.L., Jones, K.L., Lemus, H., et al. Disease severity and pregnancy outcomes in women with rheumatoid arthritis: results from the organization of teratology information specialists autoimmune diseases in pregnancy project. J Rheumatol 42 (2015), 1376–1382.
30. [30] Schlagenhauf, P., Blumentals, W.A., Suter, P., Regep, L., Vital-Durand, G., Schaerer, M.T., et al. Pregnancy and fetal outcomes after exposure to mefloquine in the pre- and periconception period and during pregnancy. Clin Infect Dis 54 (2012), e124–e131.
31. [31] Castilla-Puentes, R., Ford, L., Manera, L., Kwarta, R.F. Jr, Ascher, S., Li, Q., Topiramate monotherapy use in women with and without epilepsy: pregnancy and neonatal outcomes. Epilepsy Res 108 (2014), 717–724.