New Register-based Data on Use of Interferon Beta, Including Rebif®, in Women with Multiple Sclerosis Show No Effect on Pregnancy Outcomes

Merck, a leading science and technology company, today announced that new data on pregnancy outcomes at birth after exposure to interferon beta (IFN β), including Rebif^® (sc/subcutaneous interferon beta-1a), will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Results showed no evidence that IFN β-exposure before and during pregnancy in women with multiple sclerosis (MS) affected infant birth weight for gestational age and head circumference. The results are based on data from Finnish and Swedish health registers collected between 1996-2014.

“Our priority is ensuring we address the needs of people living with MS,” said Dr. Maria Rivas, Chief Medical Officer at Merck. “When a woman is diagnosed with MS she may have questions on continuing treatment during pregnancy and how it could affect her unborn child. We are proud to collaborate with academia and health authorities to provide relevant safety information to physicians and patients.”

Among 666 IFN β-exposed and 1,330 unexposed live births, the prevalence of pregnancy outcomes were similar and not statistically different between the IFN β-exposed versus the unexposed patients. The prevalence of small for gestational age in the exposed cohort was 2.1% (95% CI 1.2-3.5) versus 2.0% (95% CI 1.3-2.9) for the unexposed, and large for gestational age was 0.8% (95% CI 0.2-1.7) for the exposed versus 0.8% (95% CI 0.4-1.5) for the unexposed. The prevalence of low birth weight was 3.9% (95% CI 2.6-5.7) among IFN β-exposed and 4.8% (95% CI 3.7-6.1) among the unexposed. Among 619 IFN β-exposed and 1,219 unexposed full-term births, the prevalence of low head circumference was 1.9% (95% CI 1.0-3.4) among the IFN β-exposed versus 1.1% (95% CI 0.6-1.8) among the unexposed.

These data points expand on safety data presented at recent congresses, which suggest exposure to IFN β does not increase risk of spontaneous abortions or affect other pregnancy outcomes, such as ectopic pregnancies or fetal malformations.

“Most women are diagnosed with MS at a time in their lives when they may be thinking about starting or extending a family, making their treatment decision more complex,” said Professor Kerstin Hellwig, Department of Neurology at St. Josef Hospital, Germany. “These data add to our wealth of knowledge to better understand the safety of interferon beta treatment during pregnancy.”

In the EU, the initiation of Rebif during pregnancy is currently contraindicated by the European Medicines Agency (EMA), see section 4.3 and 4.6 in the EU Summary of Product Characteristics (SMPC) for Rebif. Merck has submitted regulatory filings with different health authorities to include safety data from these interferon registries in the Rebif label, and these reviews are currently ongoing.

About Rebif^®

Rebif^® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif^® in chronic progressive MS has not been established. Interferon ß is thought to help reduce inflammation. The exact mechanism is unknown.

Rebif^®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif^® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area.

Rebif^® can be administrated with the RebiSmart^® electronic auto-injection device (not approved in the US), or with the RebiDose^® single-use disposable pen, or the manual multidose injection pen RebiSlide™. Rebif^® can also be administered with the autoinjector Rebiject II^® or by manual injection using ready-to-use pre-filled syringes. These injection devices are not approved in all countries.

In January 2012, the European commission approved the extension of the indication of Rebif^® in early multiple sclerosis. The extension of the indication of Rebif^® has not been submitted in the United States. Rebif^® should be used with caution in patients with a history of depression, liver disease, thyroid abnormalities and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif^® with their doctors.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

Merck in Neurology and Immunology

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.

The company`s robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS, systemic lupus erythematosus (SLE) and forms of arthritis, including rheumatoid arthritis (RA) and osteoarthritis (OA).

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About Merck

Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 52,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2018, Merck generated sales of € 14.8 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.

¹ MS International Foundation. Who Gets MS? https://www.msif.org/about-ms/epidemiology-of-ms/. Accessed 14 August 2019
² MS International Foundation. What is MS? https://www.msif.org/about-ms/what-is-ms/. Accessed 14 August 2019.

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Contact information

Tone Brauti Fritzen
tone-brauti.fritzen@merckgroup.com
+49 151 1454 2694