Kesimpta (Ofatumumab) Pregnancy Registry

The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.

Inclusion Criteria:Participants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry:Cohort 1: Kesimpta-Exposed CohortPregnant womenDiagnosed with MS, with the indication validated by medical records when possibleAdministered Kesimpta for the treatment of MS at any time from 166 days prior to the first day of the LMP, or up to and including the end of pregnancyAgree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born childrenCohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)Pregnant womenDiagnosed with MS, with the indication validated by medical records when possibleMay or may not have taken another medication for MS in the current pregnancyAgree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born childrenCohort 3: Healthy Comparison Cohort (Comparison Group 2):Kesimpta-OTIS sub-study specificPregnant womenAgree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and validated developmental performance questionnaire in live born childrenExclusion Criteria:Women meeting any of the following criteria will be excluded from the cohort study:Cohort 1: Kesimpta-Exposed CohortWomen who have enrolled in the Kesimpta cohort study with a previous pregnancyWomen who have used Kesimpta for an indication other than a currently approved indicationWomen with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) prior to conception:Other anti-CD20 monoclonal antibody: same class as KesimptaS1P modulators: same class as MayzentCladribine (Mavenclad): Based on the US label, animal studies indicate that there is positive evidence of teratogenicity for CladribineTeriflunomide (Aubagio): The teratogenecity of teriflunomide is unknown and currently under investigation.New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)Administered Kesimpta 166 days before the first day of LMP or anytime during pregnancyWomen with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) of conception:Anti CD-20 monoclonal antibodyCladribine (Mavenclad)S1P modulatorsTeriflunomide (Aubagio) New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.Women who have enrolled in the Kesimpta cohort or BAF312A2403 Mayzent cohort with a previous pregnancyRetrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.Cohort 3: Healthy Comparison Cohort (Comparison Group 2): Only applicable to Kesimpta-OTIS sub-studyAdministered Kesimpta 166 days before or Mayzent 4 days after the first day of LMP or anytime during pregnancyWomen who have a diagnosis of a MSWomen who have a current diagnosis of any autoimmune diseaseWomen who have first contact with the project after prenatal diagnosis of any major structural defectWomen treated with Mayzent or Kesimpta for non-MS indicationRetrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.Women exposed to a known human teratogenic drugs during pregnancy