Glatiramer acetate or IFN-ß bridging therapy in women with relapsing multiple sclerosis planning a pregnancy.

Aim: To assess bridging glatiramer acetate (GA) or IFN-ß for relapse prevention in women with relapsing multiple sclerosis planning pregnancy. Materials & methods: Participants discontinued disease-modifying therapies (DMTs) and received GA/IFN (early- or delayed-start) or no DMT (control) until pregnancy. Results: Annualized relapse rate was lower in delayed-start GA/IFN cohort versus control during washout/bridging. During washout/bridging, bridging with GA/IFN in this cohort reduced clinical activity, while disease activity increased in controls versus baseline. Conclusion: More data on GA/IFN bridging are needed. Women with low relapsing multiple sclerosis activity in the year prior to DMT discontinuation due to pregnancy planning benefited from GA/IFN bridging with lower annualized relapse rate versus no treatment and reduced clinical activity versus baseline during washout/bridging and pregnancy.

When women with relapsing multiple sclerosis (RMS) plan a pregnancy, doctors must think about the possible effects of medicines. Patients can take medicines with a well-defined safety profile to reduce the risk of attacks after stopping strong treatments. In this study, women stopped taking their RMS medicines and either: took well-defined RMS medicines, glatiramer acetate (GA) or IFN-ß; or stopped all RMS medicines. The rate of attacks (in a year) was lower in patients who started taking GA/IFN a while after stopping their previous RMS medicines compared with patients who took no more medication. Women with low RMS activity in the year before stopping RMS treatment because of pregnancy planning may benefit from GA/IFN treatment prior to conception.

Safety evaluations of offspring breastfed by mothers receiving glatiramer acetate for relapsing multiple sclerosis.

BACKGROUND: Although the relapse risk is increased after birth in women with relapsing multiple sclerosis (RMS), only a very few disease-modifying therapies (DMTs) are approved during breastfeeding. Glatiramer acetate (GA, Copaxone®) is one of three DMTs that can be used in breastfeeding. The real-world safety of Copaxone® in Offsprings of Breastfeeding and treated RMS pAtients (COBRA) study demonstrated that offspring parameters (hospitalisations, antibiotic use, developmental delays, growth parameters) were similar between offspring breastfed by mothers taking GA or no DMT (control) during breastfeeding. COBRA data analyses were extended to provide further safety data on the impact of maternal GA treatment during breastfeeding on offspring. METHODS: COBRA was a non-interventional, retrospective study using German Multiple Sclerosis and Pregnancy Registry data. Participants had RMS, gave birth and had GA or no DMT during breastfeeding. Offspring total adverse events (AEs), non-serious AEs (NAEs) and serious AEs (SAEs) up to 18 months postpartum were assessed. Reasons for offspring hospitalisations and antibiotic treatments were explored. RESULTS: Baseline maternal demographics and disease characteristics were similar between cohorts. Each cohort had 60 offspring. Numbers of offspring AEs were comparable between cohorts; total AEs: 82 (GA) vs 83 (control); NAEs: 59 vs 61; SAEs: 23 vs 22. AEs in both cohorts were diverse with no specific patterns. Duration of GA-exposed breastfeeding was 6 to >574 days for offspring with any AE. For all-cause hospitalisations, 11 offspring had 12 hospitalisations (GA cohort) and 12 control offspring had 16 hospitalisations. Most common reason for hospitalisation was infection: 5/12 (41.7%; GA) vs 4/16 (25.0%, control). Two out of 12 (16.7%) hospitalisations due to infection occurred during GA-exposed breastfeeding; the others occurred 70, 192 and 257 days after discontinuation of GA-exposed breastfeeding. Median (range) duration of GA-exposed breastfeeding was 110 (56 to ≥285) days for offspring hospitalised for infections and 137 (88-396) days for those hospitalised for other reasons. Nine offspring had 13 antibiotic treatments (GA cohort) and nine control offspring had 10 treatments. Ten out of 13 (76.9%) antibiotic treatments occurred during GA-exposed breastfeeding, of which four were primarily due to double kidney with reflux. Other antibiotic treatments occurred 193, 229 and 257 days after discontinuation of GA-exposed breastfeeding. CONCLUSIONS: GA treatment of mothers with RMS during breastfeeding did not increase AEs, hospitalisations or antibiotic use in their offspring versus control offspring. These data support previous COBRA data that the benefit of maternal RMS treatment with GA during breastfeeding outweighs the potential, apparently low risk of untoward events, in their breastfed offspring.

Eighteen-month safety analysis of offspring breastfed by mothers receiving glatiramer acetate therapy for relapsing multiple sclerosis - COBRA study.

BACKGROUND: Safety data on disease-modifying therapies (DMTs) for relapsing multiple sclerosis (RMS) during breastfeeding are limited. OBJECTIVE: Assess safety outcomes for offspring breastfed by mothers undergoing glatiramer acetate (GA; Copaxone®) treatment. METHODS: This non-interventional, retrospective study used German Multiple Sclerosis and Pregnancy Registry data. Participants had RMS, a live birth, and received GA or no DMT during breastfeeding. RESULTS: GA cohort: 58 mothers/60 offspring; matched controls: 60 mothers/60 offspring; 86.7% (GA) and 25% (control) of offspring were born to mothers who had GA at some point during pregnancy. Maternal demographics and disease activity were comparable. Annualized number of hospitalizations was similar for breastfed offspring: 0.20 (95% confidence interval: 0.09-0.31; GA) and 0.25 (0.12-0.38, controls). Proportion of offspring requiring hospitalization was comparable between cohorts (18.33% vs. 20.00%). Annualized number of antibiotic uses was similar in both cohorts (0.22, 0.10-0.33 (GA) vs. 0.17, 0.06-0.27 (controls)) The proportion of offspring requiring antibiotics was 15.00% (both cohorts). More developmental delays were identified in controls versus the GA cohort (3 (5.36%) vs. 0). Growth parameters were comparable between cohorts. CONCLUSION: Maternal intake of GA during breastfeeding did not adversely affect offspring safety outcomes assessed during the first 18 months of life.

Real-world patient characteristics, treatment patterns and costs in relapsing multiple sclerosis patients treated with glatiramer acetate, dimethyl fumarate or teriflunomide in Germany.

Aim: To evaluate adherence, healthcare resource utilization (HRU) and costs for glatiramer acetate (GA; injectable), dimethyl fumarate (oral) and teriflunomide (oral) in relapsing multiple sclerosis. Patients & methods: Retrospective analyses of a claims database. Results: Teriflunomide patients were older with more co-morbidities and fewer relapses versus GA and dimethyl fumarate. GA patients were mostly disease-modifying therapies (DMTs)-treatment naive. Treatment adherence was 61-70%. All DMTs reduced HRU versus pre-index. Costs were comparable across cohorts. High adherence reduced hospitalizations and several costs versus low adherers. Conclusion: Adherence rates were high and comparable with all DMTs. Similar (and high) reductions in HRU and costs occurred with all DMTs. High adherence improved economic outcomes versus low adherence. Thus, investing in adherence improvement is beneficial to improve outcomes in relapsing multiple sclerosis.

Drugs used for relapsing multiple sclerosis (RMS) include, among others, glatiramer acetate (injection), dimethyl fumarate (tablet) and teriflunomide (tablet). We compared treatment adherence (based on drug claims), healthcare use and costs for these drugs. Treatment adherence and healthcare use was similar for these three drugs. The need to be in hospital was lower with these drugs compared with not using them. No differences in treatment costs were seen between these drugs. Adherence reduced the need for hospital stays and lowered some costs compared with patients who were classified as adherent. RMS patients should be encouraged to take their RMS medication as prescribed. Improving treatment adherence will have a positive effect on RMS, and a good impact on healthcare use and costs.