adverse events

Taking Copaxone (glatiramer acetate), an approved therapy for relapsing forms of multiple sclerosis (MS), while breastfeeding does not appear to be harmful to infants during their first 18 months, according to a real-life study in Germany called COBRA. “In this study, we compared the development of 120 children in total, whose…

Reports of psoriasis — an autoimmune skin disease that shares some biological processes with multiple sclerosis (MS) — are disproportionally high among MS patients on therapies that deplete B-cells, according to a U.S. study based on patient adverse event data. Conversely, patients on Tysabri (natalizumab), glatiramer acetate (sold…

The label of Copaxone (glatiramer acetate) — an approved therapy for relapsing forms of multiple sclerosis (MS) — has been updated in Europe to no longer contain a warning against its use during breastfeeding. The label update follows a review by European Union health authorities of non-clinical and clinical evidence submitted…

People with relapsing-remitting multiple sclerosis (RRMS) using approved oral disease-modifying therapies generally tolerate the treatments well, with real-world adverse event profiles similar to those seen in clinical trials, an analysis of U.S. data indicates. Results also suggest high adherence to these therapies — meaning patients are usually taking the therapies…

The use of disease-modifying therapies (DMTs) in adults with multiple sclerosis (MS) increased the risk of precancerous growth in those older than 45 years of age, according to an age-related adverse events analysis of several dozen clinical trials. …

Ocrevus (ocrelizumab), a second-generation anti-CD20 antibody, may be associated with a greater risk of infections. But it carries a lower risk of cancer and immune reactions than first-generation rituximab in people with multiple sclerosis (MS), according to a real-life study. The higher incidence of infections linked with Ocrevus’…

Treatment with Lemtrada (alemtuzumab) is associated with the death of patients with relapsing-remitting multiple sclerosis (RRMS) more often than previously reported and appears to be most common during the first month, according to a European review. The study, “Adverse events with fatal outcome associated…

Biogen and AbbVie have voluntarily withdrawn global marketing authorizations for their relapsing multiple sclerosis therapy Zinbryta (daclizumab) because of serious side effects that include brain inflammation. The Europe Medicine Agency, which oversees medications across the European Union, also released a statement recommending a “immediate suspension” of Zinbryta’s use by patients and…

I posted this meme on social media last week with the caption “Current Life Status,” hoping a laugh might help matters. I’m sorry to say things didn’t improve afterward. I’m not a Debbie Downer or a Sad Sack by nature, and I don’t often write about my struggles here…

The multiple sclerosis therapy Tysabri could trigger melanoma, the Southern Network on Adverse Reactions (SONAR) has warned. Although its investigation failed to demonstrate that melanoma is more common among Tysabri-treated MS patients than in the general population, unusual features among the patients raise concerns about a possible link, the organization said. Contending that current monitoring efforts are inadequate, it suggested improvements that could generate a better understanding of the relationship between Tysabri treatment and cancer. The organization's report, published in the journal Cancer Medicine, was titled “Melanoma complicating treatment with natalizumab for multiple sclerosis: A report from the Southern Network on Adverse Reactions, also known as SONAR." SONAR is an organization that was formed in the Southern United States in 2010 to investigate adverse drug reactions that regulators might not be aware of. Its goal is to reduce the time it takes between detecting an adverse reaction and have regulators act on it. A case that a SONAR investigator came across led to the group investigating possible links between Tysabri and melanoma. A 43-year-old woman developed melanoma in her urethra, the tubing that drains urine from the bladder, after being treated with Tysabri for about two years. Melanoma is most often a skin cancer that is related to sun exposure, but the woman had no skin lesions. After extensive surgery, she relapsed and died when the cancer spread to other parts of her body. She had declined anti-cancer treatment. The case prompt SONAR to look for similar cases. Its investigators found seven studies that involved Tysabri-treated MS patients developing melanoma. In addition, they looked through the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) and the Tysabri Safety Surveillance Program. The surveillance program is part of the Tysabri Outcomes Unified Commitment to Health (TOUCH) database run by Tysabri's developer, Biogen, The research team found 137 cases in the FAERS database through April 1, 2014. The patients' average age was 45. Seventeen percent of the group developed tumors in locations not exposed to the sun, and nine died. The researchers said the database contained only about half the information it should have, such as tumor site, patients' family history of cancer, and earlier immunosuppressive treatment. Fifteen percent of the cases in the FAERS database were based entirely on information from the TOUCH database. Seventy-three percent were cases initially reported to FAERS but with TOUCH information added. Thirteen percent of the FAERS cases contained no additional information. Importantly, there was even less patient information in the TOUCH database than in the FAERS database. Out of eight items researchers believe a database should contain, TOUCH had information on two, on average. “The existence of the TOUCH Safety Surveillance Program, an FDA-mandated program, did not improve melanoma reporting,” the team wrote. This shortage of data stymies research into possible links between Tysabri treatment and melanoma, the researchers said. As an example, although the death rates in the databases were low, there was no information about survival in many cases, which could lead to flawed survival estimates. The investigation noted that patients received a wide range of Tysabri doses before they were diagnosed with melanoma. While some received only one or a few injections, others had been treated for a long time. These observations do not seem to support a link between Tysabri and melanoma, the team said. “A longer therapy duration would be expected if natalizumab caused melanoma via an immunologic pathway, unless existing nevi [lesions of the skin or mucus tissue] were already premalignant lesions,” the researchers wrote. But other information the team found seemed to suggest a Tysabri-melanoma link. For example, the average age of melanoma patients was much lower than that reported in the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) database. The average age in the institute's database is 63, compared with 45 in the FAERS database and 41 in cases in academic journals. In addition, many patients developed tumors in unusual places not exposed to sunlight. Finally, the low melanoma death rate in Tysabri-treated patients differed from that seen in the general population. All these factors suggest that melanoma after Tysabri treatment could differ from other types of melanoma, the researchers argued. While the molecular workings of Tysabri might promote melanoma growth, studies so far have not found a relationship between the drug and this cancer. In fact, some studies suggest that MS patients, in general, have a lower risk of melanoma than others. The team said more information on patients could give researchers a better understanding of the potential relationship between Tysabri and melanoma. The implication was that the standard of reporting in the FAERS and TOUCH databases could improve. To minimize the risk of patients who receive Tysabri developing melanoma, the researchers offered a number of suggestions for IV centers, physicians, patients, and educational programs. For instance, they suggested that all patients should have a skin examination before the start of treatment, and regular physical and skin exams while receiving Tysabri. While noting that risk of infection and the development of tumors can occur with all immunosuppressive treatments, the team said more studies are needed to explore the risk of Tysabri-treated patients developing melanoma.

Autoimmune side effects during five years of Lemtrada (alemtuzumab) treatment were generally not serious and mainly affected the thyroid, according to an analysis of patients in three large, Phase 3 clinical trials of the therapy. The data were presented at the Free Communications 1 session of the European Committee…