title: Prospectively-followed pregnancies in patients with inflammatory arthritis taking biological drugs: an Italian multicentre study.
abstract: OBJECTIVE
  Information on new drugs does not include their possible effects on pregnancy because pregnant women are excluded from clinical trials. Although not classified as teratogenic in animals, limited data is available on biological anti-rheumatic agents and their safety in human pregnancy. The aim of the study is to evaluate the safety of biological drugs in pregnant patients with chronic arthritis.
  
  
  METHODS
  Pregnancy outcome and maternal disease variations were prospectively followed in six Italian Rheumatology Centres. Patients exposed to biological agents during the periconceptional period or during pregnancy were included in the study. The occurrence of congenital malformations as well as the obstetric and neonatal outcomes were assessed.
  
  
  RESULTS
  Between 1999 and 2013 we identified 79 exposed pregnancies in 67 women affected by different rheumatic diseases with peripheral chronic arthritis. At the time of the start of pregnancy, 56 patients were taking etanercept, 13 adalimumab, 3 infliximab, 2 each certolizumab-pegol and rituximab, 1 each golimumab, anakinra and abatacept. Biological treatment was stopped after a mean of 41 days since documented pregnancy. Live births were reported in 66% of pregnancies. The rate of spontaneous pregnancy loss was 20%. Only one congenital malformation was reported.
  
  
  CONCLUSIONS
  TNF-alpha inhibitors can be considered safe in the periconception period, representing a possible therapeutic choice also in young women affected by an aggressive form of chronic arthritis and hoping for a pregnancy. Reports of exposure during 2nd/3rd trimester are still limited and suggest caution. Experience with abatacept, tocilizumab, anakinra and rituximab in pregnancy is insufficient.
authors: Rheumatology and Clinical Immunology Unit, Spedali Civili di Brescia, Italy.
authors: Chiara
authors: C
authors: Bazzani
authors: Department of Internal Medicine and Medical Specialties, Rheumatology Unit, La Sapienza University, Rome, Italy.
authors: Rossana
authors: R
authors: Scrivo
authors: Rheumatology and Clinical Immunology Unit, Spedali Civili di Brescia; and Department of Clinical and Experimental Sciences, University of Brescia, Italy.
authors: Laura
authors: L
authors: Andreoli
authors: Department of Internal Medicine and Clinical Immunology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
authors: Elena
authors: E
authors: Baldissera
authors: Department of Clinical Sciences and Community Health, University of Milan, Istituto G. Pini and IRCCS Istituto Auxologico Italiano, Milan, Italy.
authors: Martina
authors: M
authors: Biggioggero
authors: Department of Internal Medicine and Clinical Immunology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
authors: Valentina
authors: V
authors: Canti
authors: Department of Clinical Sciences and Community Health, University of Milan, Istituto G. Pini and IRCCS Istituto Auxologico Italiano, Milan, Italy.
authors: Maria
authors: M
authors: Gerosa
authors: Department of Clinical Sciences and Community Health, University of Milan, Istituto G. Pini and IRCCS Istituto Auxologico Italiano, Milan, Italy.
authors: Irene
authors: I
authors: Pontikaki
authors: Rheumatology Unit, IRCCS Policlinico S. Matteo Foundation, University of Pavia, Italy.
authors: Véronique
authors: V
authors: Ramoni
authors: Obstetric and Gynecology Department, IIRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Mangiagalli, Regina Elena, Milan, Italy.
authors: Laura
authors: L
authors: Trespidi
authors: Obstetric and Gynecology Department, Spedali Civili di Brescia, Italy.
authors: Sonia
authors: S
authors: Zatti
authors: Rheumatology Unit, IRCCS Policlinico S. Matteo Foundation, University of Pavia, Italy.
authors: Roberto
authors: R
authors: Caporali
authors: Rheumatology and Clinical Immunology Unit, Spedali Civili di Brescia, Italy.
authors: Roberto
authors: R
authors: Gorla
authors: Department of Internal Medicine and Public Medicine, Rheumatology Unit, University of Bari, Italy.
authors: Florenzo
authors: F
authors: Iannone
authors: Department of Clinical and Experimental Sciences, University of Brescia; and Obstetric and Gynecology Department, Spedali Civili di Brescia, Italy.
authors: Andrea
authors: A
authors: Lojacono
authors: Department of Clinical Sciences and Community Health, University of Milan, Istituto G. Pini and IRCCS Istituto Auxologico Italiano, Milan, Italy.
authors: Pierluigi
authors: P
authors: Meroni
authors: Rheumatology Unit, IRCCS Policlinico S. Matteo Foundation, University of Pavia, Italy.
authors: Carlomaurizio
authors: C
authors: Montecucco
authors: Neonatology and Neonatal Intensive Care Unit, Spedali Civili di Brescia, Italy.
authors: Mario
authors: M
authors: Motta
authors: Department of Internal Medicine and Clinical Immunology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
authors: Maria Grazia
authors: MG
authors: Sabbadini
authors: Department of Internal Medicine and Medical Specialties, Rheumatology Unit, La Sapienza University, Rome, Italy.
authors: Guido
authors: G
authors: Valesini
authors: Rheumatology and Clinical Immunology Unit, Spedali Civili di Brescia; and Department of Clinical and Experimental Sciences, University of Brescia, Italy.
authors: Angela
authors: A
authors: Tincani
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000209:etiology; D000022:Abortion, Spontaneous / Q000209:etiology; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001168:Arthritis / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D005260:Female; D006801:Humans; D007558:Italy; D050498:Live Birth; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors / Q000276:immunology
chemical_list: D000893:Anti-Inflammatory Agents; D001688:Biological Products; D014409:Tumor Necrosis Factor-alpha