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Inflammatory Bowel Disease
Published in Vincenzo Berghella, Maternal-Fetal Evidence Based Guidelines, 2022
Sulfasalazine, mesalamine, balsalazide, and olsalazine are in this category. Drugs in this category have limited placental transfer and are generally considered safe for use in pregnancy and in breastfeeding. Aminosalicylates have not been shown to be teratogenic in humans [41–45]. They have not been shown to be associated with stillbirth, spontaneous abortion, preterm delivery, or low birth-weight [41].
Gastrointestinal diseases and pregnancy
Published in Hung N. Winn, Frank A. Chervenak, Roberto Romero, Clinical Maternal-Fetal Medicine Online, 2021
Murtaza Arif, Anjana Sathyamurthy, Jessica Winn, Jamal A. Ibdah
Aminosalicylates are one of the cornerstones of medical therapy of IBD and are considered low risk for use in pregnancy. Most are pregnancy category B (sulfasalazine, mesalamine, and balsalazide) with the exception of olsalazine, which is category C. Sulfasalazine contains a sulfapyridine residue linked to 5-aminosalicylic acid (5-ASA), the active moiety. Its mechanism of action is unknown, but it has been shown to inhibit production of leukotriene B4, an important mediator of inflammation, block prostaglandin production, and inhibit immunoglobulin secretion by mononuclear cells. Sulfasalazine crosses the placenta (85) and is found in breast milk, although in low concentrations. Serum levels of sulfasalazine in newborns are the same as in the mother (86). This drug is thought to be safe during pregnancy (87). There are a few case reports of congenital defects in infants of treated patients; however, a population-based study did not find a significant increase in congenital abnormalities in children of women treated with sulfasalazine (88). Its efficacy in maintaining remission in UC makes its continuation during pregnancy an important consideration. Patients are usually tapered to the lowest dose that is effective in suppressing disease activity. Sulfasalazine has anti-folate effects, and it is recommended that women take folate supplementation of at least 2mg daily during the prenatal period and pregnancy.
Gastrointestinal disease
Published in Catherine Nelson-Piercy, Handbook of Obstetric Medicine, 2020
Oral and topical 5-aminosalicylates (e.g. sulfasalazine [see Chapter 8], mesalazine) used for maintaining and inducing remission in women with UC and colonic CD may be safely used throughout pregnancy and breastfeeding.
Use of medications during pregnancy and breastfeeding for Crohn’s disease and ulcerative colitis
Published in Expert Opinion on Drug Safety, 2021
Robyn Laube, Sudarshan Paramsothy, Rupert W Leong
Mesalazine ingested by pregnant women reaches only low levels in the fetal circulation due to poor transplacental transfer and rapid renal excretion [20,21]. It has not been associated with an increased risk of congenital abnormalities, and is considered to be safe for use during pregnancy [22–25]. A meta-analysis found no increased risk of preterm delivery (OR 1.35, 95%CI: 0.85–2.13), spontaneous abortion (OR 1.14, 95%CI: 0.65–2.01), stillbirth (OR 2.38, 95%CI: 0.65–8.72) or congenital abnormalities (OR 1.16, 95%CI: 0.76–1.77) with 5-aminosalicylates (5-ASAs) administered during gestation [25]. An old case report raised concern about neonatal renal impairment secondary to high dose mesalazine [26], however the plausibility of this has been questioned [27]. Some small studies also raised concerns about 5-ASAs increasing the risk of preterm birth, stillbirth and LBW [28,29]. However, these studies were confounded by active disease and concomitant medications, and such findings have not been borne out in larger studies. Mesalazine is therefore considered to be safe for pregnant women in doses up to 3 g/day [14,25,30]. The exception is 5-ASA formulations coated with dibutyl phthalate (DBP), which has been implicated in causing male urogenital tract and skeletal abnormalities in animals, and dysregulation of thyroid and reproductive hormones in humans [31–33]. 5-ASAs coated with DBP should therefore be avoided during pregnancy, although DBP has been removed from 5-ASAs in most countries [34].
Is there room for immunomodulators in ulcerative colitis?
Published in Expert Opinion on Biological Therapy, 2020
Advances in medical therapy have improved the overall prognosis of patients with UC. Correspondingly, as biologic and novel oral small molecule therapies are incorporated into management algorithms, treatment decisions for UC have become more complex. Topically and orally administered aminosalicylates have remained the gold standard for inducing and maintaining remission in patients with mild-to-moderate UC because of their favorable cost, efficacy, and safety profile [20–23]. On the other hand, biologic therapies have taken a prominent role in the management of moderate-to-severe disease given their rapid onset, high degree of efficacy, and favorable long-term safety profile. This leaves the role of traditional immunomodulators (IMMs) such as thiopurines and methotrexate somewhat ambiguous. In this review, we summarize the mechanism of action of IMMs, identify clinical parameters for their use in UC, and appraise the evidence supporting the efficacy and safety of IMMs in UC either as monotherapy or as combination therapy.
Short- and long-term efficacy of adalimumab salvage therapy after failure of calcineurin inhibitors in steroid-refractory ulcerative colitis
Published in Scandinavian Journal of Gastroenterology, 2018
Masafumi Nishio, Yoshito Ishii, Yu Hashimoto, Haruka Otake, Tsuyoshi Ogashiwa, Saya Tsuda, Hisae Yasuhara, Yusuke Saigusa, Hideaki Kimura, Shin Maeda, Reiko Kunisaki
We investigated predictive factors of colectomy and clinical remission to identify patients who would benefit from adalimumab salvage therapy. We found that a shorter duration of UC and a higher CAI score when starting adalimumab treatment were associated with a higher probability of colectomy in the follow-up period. Of 17 patients who underwent colectomy, 6 (35%) were initially treated with 5-aminosalicylate and corticosteroid, but experienced exacerbation of UC because of intolerance to 5-aminosalicylate. These patients underwent a colectomy at a median UC duration of 0.9 years (range 0.2–2.0 years). In previous studies, up to 30% of patients showed intolerance or hypersensitivity to 5-aminosalicylate treatment, including exacerbation of UC [25–27]. These results suggest that adalimumab salvage therapy is not sufficiently effective for patients with acute and severe disease, including exacerbation of UC because of 5-aminosalicylate intolerance, despite treatment with corticosteroids and calcineurin inhibitors. Importantly, colectomy should be recommended without delay for these patients with severe disease.