Safety of biologic therapies during pregnancy in women with rheumatic disease

Table 2 Tumor necrosis factor inhibitors use during pregnancy and the conception period

Ref./registry	No. of pregnancies	Disease	Biologic drugs	Pregnancy stage	Pregnancy outcome
Lichtenstein et al[61] TREAT registry	36	CD	IFX	Any exposure	11.1% miscarriage (NS), 8.3% neonatal complications (NS)
Katz et al[62] Infliximab safety database	96	CD, UC, RA	IFX	7 prior to conception, 53 conception, 30 T1, 6 unknown	67% live births, 15% miscarriages, and 19% elective termination. Results similar to those expected for the general United States population or pregnant women with CD not exposed to infliximab
Garcia et al[50] BIOBADASER	14	RA, AS, PsA	IFX, ETN, ADA	First trimester	7 live births, 1 miscarriage, 3 therapeutic termination, 3 therapeutic termination, 2 on-going pregnancies, 0 malformations
Strangfeld et al[10] RABBIT	37		IFX, ETN, ADA, ANK	22 first-trimester (2 restarted biologic after week 20) 15 prior to conception	Similar miscarriage (4.5% vs 6.6%); 0 marformations
Johnson et al[17] OTIS	175	RA, PsA, AS, CPs	ETN	139 first trimester 67 disease matched	Similar live births (93.5% vs 88.1%); more miscarriage (14% vs 5% vs 1.1%); malformations (9.4% vs 4.5%)
Verstappen et al[11] BSRBR	140	RA, PsA, JIA, AS, SLE, AOSD	IFX, ETN, ADA	59 prior conception 71 at conception 10 controls never exposed	In post-conception exposures vs never exposed: less live births (59% vs 100%; P = 0.012), more miscarriages (27% vs 10%; P = 0.437), elective terminations (11% vs 10%; P = 0.587)
Chambers et al[14] OTIS	239	RA, CD	ADA	94 first trimester 58 disease-matched controls 87 non-disease controls	Similar live births (85% vs 91.4% vs 89.7%), miscarriages (4.3% vs 9%); similar preterm deliveries (15% vs 17% vs 4%); malformations (9.6% vs 5.4% vs 5%)

Experience from national registries. CD: Crohn’s disease; UC: Ulcerative colitis; RA: Rheumatoid arthritis; PsA: Psoriatic arthritis; JIA: Juvenile idiopathic arthritis; AS: Ankylosing spondylitis; SLE: Systemic lupus erythematosus; AOSD: Adult onset still disease; CPs: Cutaneous psoriasis; BSRBR: British society for rheumatology biologics register; NS: Non-significant; T1: First-trimester; IFX: Infliximab; ETN: Etanercept; ADA: Adalimumab.