Pregnancy outcomes in women with pemphigus exposed to rituximab before or during pregnancy

Abstract

Background: Rituximab (RTX) is an effective treatment for pemphigus; however, the drug labeling recommends not to use RTX within 1 year before conception. Objectives: To report pregnancy outcomes of patients with pemphigus who were treated with RTX before or during pregnancy. Methods: We identified 19 pregnancies with RTX exposure before or during pregnancy. All had previously been advised not to get pregnant within 1 year of RTX administration. The cases were categorized into 3 groups of exposure of within 6 months (group A), between 6 and 12 months (group B), and longer than 12 months of conception (group C). The pregnancy outcomes of different RTX exposure intervals were compared. Results: Group A included 9 pregnancies, of which 3 had received RTX accidentally after conception. Group B and C included 4 and 6 pregnancies, respectively. There was no significant difference between the groups regarding pregnancy outcomes. Overall, there were 17 live births, 1 spontaneous abortion, and 1 termination. Of the live births, 3 preterm deliveries and 4 low-birth-weight neonates were noted. Moreover, 1 neonate was hospitalized due to early-onset neonatal sepsis, and 1 had hydronephrosis. Disease flare-up occurred in 5 patients during pregnancy (4 minor and 1 major relapses) and in 5 patients after delivery (3 minor and 2 major relapses). Conclusions: Except for 1 case of neonatal sepsis which survived following medical treatment, no serious relevant adverse pregnancy outcome that could be attributed to RTX exposure before and during early pregnancy in women with pemphigus was detected. Nevertheless, RTX should not be administered within 1 year before planned pregnancy, as not enough data is available yet.

Applicability of glucocorticoid toxicity index in pemphigus: Comparison between two groups of rituximab‐treated and rituximab‐naïve patients

“…21,22 Various studies have confirmed the efficacy of RTX in pemphigus. 2,14,[23][24][25] This agent provided an opportunity for GC reduction and therefore minimizing long-term GC adverse events. The present study demonstrated that patients treated with GC alone had significantly higher GTI over 1 year of treatment compared to patients treated with GC plus RTX.…”

“…Systemic GCs have greatly improved the prognosis of pemphigus, 20 but the burden of disease remains high with the comorbidities caused by this treatment 21,22 . Various studies have confirmed the efficacy of RTX in pemphigus 2,14,23–25 . This agent provided an opportunity for GC reduction and therefore minimizing long‐term GC adverse events.…”

Burden of pemphigus vulgaris with a particular focus on women: A review

“…More recently, various case series also reported the possible use of RTX in vulnerable patients. [20][21][22][23] Azathioprine (AZT) (2 mg/kg/d) and MMF (2 g/d) were the most commonly used first-line CS-sparing agents in PV before identifying the efficacy of RTX. 16,17 Nowadays, they are prescribed when RTX is contraindicated or lacks insurance coverage.…”

“…More recently, various case series also reported the possible use of RTX in vulnerable patients. 20–23…”

Pemphigus vulgaris in a neonate born to a mother with pemphigus vulgaris: A case report

“…However, in pregnant patients, mycophenolate mofetil, methotrexate, and azathioprine should be avoided 5 . Nowadays, rituximab and corticosteroids are considered the first‐line agents for treating PV 6–8 . Since neonatal PV is usually self‐limiting, it does not require specific intervention.…”