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NEW ORLEANS – Data from the ocrelizumab clinical development program gives clinicians a first look at pregnancy outcomes after exposure to the drug, but the small size limits the ability to draw firm conclusions.
In the United States, prescribing information for ocrelizumab states that women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion. At the annual meeting of the Consortium of Multiple Sclerosis Centers, researchers led by Sibyl Wray, MD, set out to assess the pregnancy, fetal, neonatal and infant outcomes in patients who became pregnant during ocrelizumab trials in MS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) through Sept. 15, 2015.
The analysis included ocrelizumab-exposed women in primarily European-based clinical trials in patients with MS, RA, or SLE, in whom doses ranged from 20 mg to 2,000 mg. These included three randomized trials of its use in MS, totaling 1,876 patients with a mean age of 40 years; four trials of its use in RA, totaling 2,759 patients with a mean age of 53 years; and one trial of its use in SLE, totaling 381 patients with a mean age of 31 years. Between 2008 and Sept. 14, 2015, a total of 48 women who were enrolled in the trials reported pregnancies.
MS data
Of the 15 pregnancies in the MS trials, three involved the delivery of full term, healthy newborns. In one case, the last ocrelizumab infusion was given 28 months before conception. In the second case, an infusion was given 20 weeks before conception, and a further infusion was given 17 days after conception. In the third case, the last ocrelizumab infusion was given 26.5 weeks before conception.
One live term birth occurred with an abnormal finding. In this case, the last infusion of ocrelizumab was 23 weeks prior to the last menstrual period or about 6 months prior to conception. The embryo/fetus was not exposed to the drug in utero. The researchers also found that seven elective terminations occurred among MS patients and that four pregnancies were ongoing at the time of this report.
“We have to be cautious because we don’t have enough data yet to know, but it’s encouraging to see that, if you follow the guidelines, the patient population and the newborns seem to be healthy in these exposed individuals,” Dr. Wray said.
RA data
Data from the RA clinical trials revealed 22 pregnancies in 21 patients exposed to ocrelizumab. Of these, eight pregnancies resulted in healthy term babies; four resulted in live births with abnormal findings (structural malformation, growth abnormality) or preterm birth; and eight pregnancies in seven women resulted in spontaneous abortion (one patient experienced a spontaneous abortion on two occasions), missed abortion, or an embryonic pregnancy. One pregnancy was lost to follow-up and another resulted in elective termination.
SLE data
During the SLE trials, 11 pregnancies occurred in 10 patients. Three pregnancies in two women resulted in healthy term babies. Three other pregnancies resulted in live births with an abnormal finding (structural malformation, functional deficit, growth abnormality) and/or preterm birth. Two pregnancies resulted in spontaneous/missed abortion. One pregnancy resulted in fetal death at 7.5 months’ gestation secondary to fatal pulmonary embolism in the mother; one pregnancy resulted in elective termination; and one pregnancy resulted in a healthy baby born at an unknown gestational week.
Dr. Wray emphasized that the small numbers of patients studied make it difficult to draw conclusions about pregnancy outcomes following ocrelizumab in patients with MS and other autoimmune diseases. “We need to pay attention to the half-life of this drug, the time it takes to clear, and how to plan pregnancies around that,” she said. She noted that pregnancy outcomes in ongoing ocrelizumab studies and postmarketing experiences will continue to be collected and assessed.
The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.
NEW ORLEANS – Data from the ocrelizumab clinical development program gives clinicians a first look at pregnancy outcomes after exposure to the drug, but the small size limits the ability to draw firm conclusions.
In the United States, prescribing information for ocrelizumab states that women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion. At the annual meeting of the Consortium of Multiple Sclerosis Centers, researchers led by Sibyl Wray, MD, set out to assess the pregnancy, fetal, neonatal and infant outcomes in patients who became pregnant during ocrelizumab trials in MS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) through Sept. 15, 2015.
The analysis included ocrelizumab-exposed women in primarily European-based clinical trials in patients with MS, RA, or SLE, in whom doses ranged from 20 mg to 2,000 mg. These included three randomized trials of its use in MS, totaling 1,876 patients with a mean age of 40 years; four trials of its use in RA, totaling 2,759 patients with a mean age of 53 years; and one trial of its use in SLE, totaling 381 patients with a mean age of 31 years. Between 2008 and Sept. 14, 2015, a total of 48 women who were enrolled in the trials reported pregnancies.
MS data
Of the 15 pregnancies in the MS trials, three involved the delivery of full term, healthy newborns. In one case, the last ocrelizumab infusion was given 28 months before conception. In the second case, an infusion was given 20 weeks before conception, and a further infusion was given 17 days after conception. In the third case, the last ocrelizumab infusion was given 26.5 weeks before conception.
One live term birth occurred with an abnormal finding. In this case, the last infusion of ocrelizumab was 23 weeks prior to the last menstrual period or about 6 months prior to conception. The embryo/fetus was not exposed to the drug in utero. The researchers also found that seven elective terminations occurred among MS patients and that four pregnancies were ongoing at the time of this report.
“We have to be cautious because we don’t have enough data yet to know, but it’s encouraging to see that, if you follow the guidelines, the patient population and the newborns seem to be healthy in these exposed individuals,” Dr. Wray said.
RA data
Data from the RA clinical trials revealed 22 pregnancies in 21 patients exposed to ocrelizumab. Of these, eight pregnancies resulted in healthy term babies; four resulted in live births with abnormal findings (structural malformation, growth abnormality) or preterm birth; and eight pregnancies in seven women resulted in spontaneous abortion (one patient experienced a spontaneous abortion on two occasions), missed abortion, or an embryonic pregnancy. One pregnancy was lost to follow-up and another resulted in elective termination.
SLE data
During the SLE trials, 11 pregnancies occurred in 10 patients. Three pregnancies in two women resulted in healthy term babies. Three other pregnancies resulted in live births with an abnormal finding (structural malformation, functional deficit, growth abnormality) and/or preterm birth. Two pregnancies resulted in spontaneous/missed abortion. One pregnancy resulted in fetal death at 7.5 months’ gestation secondary to fatal pulmonary embolism in the mother; one pregnancy resulted in elective termination; and one pregnancy resulted in a healthy baby born at an unknown gestational week.
Dr. Wray emphasized that the small numbers of patients studied make it difficult to draw conclusions about pregnancy outcomes following ocrelizumab in patients with MS and other autoimmune diseases. “We need to pay attention to the half-life of this drug, the time it takes to clear, and how to plan pregnancies around that,” she said. She noted that pregnancy outcomes in ongoing ocrelizumab studies and postmarketing experiences will continue to be collected and assessed.
The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.
NEW ORLEANS – Data from the ocrelizumab clinical development program gives clinicians a first look at pregnancy outcomes after exposure to the drug, but the small size limits the ability to draw firm conclusions.
In the United States, prescribing information for ocrelizumab states that women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion. At the annual meeting of the Consortium of Multiple Sclerosis Centers, researchers led by Sibyl Wray, MD, set out to assess the pregnancy, fetal, neonatal and infant outcomes in patients who became pregnant during ocrelizumab trials in MS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) through Sept. 15, 2015.
The analysis included ocrelizumab-exposed women in primarily European-based clinical trials in patients with MS, RA, or SLE, in whom doses ranged from 20 mg to 2,000 mg. These included three randomized trials of its use in MS, totaling 1,876 patients with a mean age of 40 years; four trials of its use in RA, totaling 2,759 patients with a mean age of 53 years; and one trial of its use in SLE, totaling 381 patients with a mean age of 31 years. Between 2008 and Sept. 14, 2015, a total of 48 women who were enrolled in the trials reported pregnancies.
MS data
Of the 15 pregnancies in the MS trials, three involved the delivery of full term, healthy newborns. In one case, the last ocrelizumab infusion was given 28 months before conception. In the second case, an infusion was given 20 weeks before conception, and a further infusion was given 17 days after conception. In the third case, the last ocrelizumab infusion was given 26.5 weeks before conception.
One live term birth occurred with an abnormal finding. In this case, the last infusion of ocrelizumab was 23 weeks prior to the last menstrual period or about 6 months prior to conception. The embryo/fetus was not exposed to the drug in utero. The researchers also found that seven elective terminations occurred among MS patients and that four pregnancies were ongoing at the time of this report.
“We have to be cautious because we don’t have enough data yet to know, but it’s encouraging to see that, if you follow the guidelines, the patient population and the newborns seem to be healthy in these exposed individuals,” Dr. Wray said.
RA data
Data from the RA clinical trials revealed 22 pregnancies in 21 patients exposed to ocrelizumab. Of these, eight pregnancies resulted in healthy term babies; four resulted in live births with abnormal findings (structural malformation, growth abnormality) or preterm birth; and eight pregnancies in seven women resulted in spontaneous abortion (one patient experienced a spontaneous abortion on two occasions), missed abortion, or an embryonic pregnancy. One pregnancy was lost to follow-up and another resulted in elective termination.
SLE data
During the SLE trials, 11 pregnancies occurred in 10 patients. Three pregnancies in two women resulted in healthy term babies. Three other pregnancies resulted in live births with an abnormal finding (structural malformation, functional deficit, growth abnormality) and/or preterm birth. Two pregnancies resulted in spontaneous/missed abortion. One pregnancy resulted in fetal death at 7.5 months’ gestation secondary to fatal pulmonary embolism in the mother; one pregnancy resulted in elective termination; and one pregnancy resulted in a healthy baby born at an unknown gestational week.
Dr. Wray emphasized that the small numbers of patients studied make it difficult to draw conclusions about pregnancy outcomes following ocrelizumab in patients with MS and other autoimmune diseases. “We need to pay attention to the half-life of this drug, the time it takes to clear, and how to plan pregnancies around that,” she said. She noted that pregnancy outcomes in ongoing ocrelizumab studies and postmarketing experiences will continue to be collected and assessed.
The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.
AT THE CMSC ANNUAL MEETING
Key clinical point:
Major finding: Of 15 pregnancies in the MS trials, three involved the delivery of three full term, healthy newborns; one live term birth occurred with an abnormal finding; seven elective terminations occurred; and four pregnancies were ongoing.
Data source: A review of 48 pregnancies among women enrolled in clinical trials for ocrelizumab in MS, rheumatoid arthritis, and systemic lupus erythematosus.
Disclosures: The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.