Background Biosimilar tumour necrosis factor inhibitors (TNFi) are increasingly used to treat inflammatory immune-mediated disorders as they cost less than the originator biologic drug. More women are therefore becoming pregnant on biosimilar TNFi. This is the first paper to explore the safety and efficacy of biosimilar therapies in pregnancy. Methods A retrospective review of clinical data reviewed pregnancy outcomes and inflammatory disease activity in 18 pregnancies where the mother was using a biosimilar TNFi at conception. Results Biosimilar therapy was not associated with congenital abnormalities, preterm birth or other adverse pregnancy outcomes. Stopping biosimilar TNFi in pregnancy was associated with childbirth at an earlier gestation, as well as a flare of inflammatory disease in pregnancy or post-partum. Conclusions Women and clinicians should feel confident in using biosimilar TNFi in early pregnancy, and continuing them through pregnancy to prevent flares in late pregnancy or the early post-partum.
BackgroundSequential drug treatment with biological agents in ulcerative colitis (UC) is becoming increasingly complex. There are few studies comparing head-to-head outcomes in second-line treatments. The study assesses whether using anti-tumour necrosis factor (anti-TNF)-α therapy following the α4β7 integrin blocker vedolizumab (VDZ) or VDZ after an anti-TNF has more favourable clinical outcomes in UC in a real-world outpatient setting.MethodsPatients with UC who were exposed to first-line anti-TNF (adalimumab or infliximab) or VDZ who subsequently switched to the alternate class between May 2013 and August 2020 were identified by reviewing patient databases at 10 hospitals. Data were collected retrospectively using patient records. Baseline demographics, disease activity indices, biochemical markers, endoscopic Mayo score, colectomy rates, treatment persistence and urgent hospital utilisation composite endpoint (UHUC) rates were examined over a 52-week period.ResultsSecond-line week 52 treatment persistence was higher in the VDZ group (71/81, 89%) versus the anti-TNF group (15/34, 44%; p=0.0001), as were week 52 colectomy-free survival (VDZ: 77/80, 96%, vs anti-TNF: 26/32, 81%; p=0.009), week 52 UHUC survival (VDZ: 68/84, 81%, vs anti-TNF: 20/34, 59%; p=0.002) and week 52 corticosteroid-free clinical remission (CFCR) rates (VDZ: 22/34, 65%, vs anti-TNF: 4/20, 20%; p=0.001).ConclusionCompared with second-line anti TNF usage, the VDZ second-line cohort had significantly higher 52-week treatment persistence, UHUC survival, higher colectomy-free survival rates and higher week 52 CFCR. These data suggest that VDZ is an effective biologic in UC as a second-line therapy after anti-TNF exposure. It highlights the effect of biological order on clinically important outcomes.
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