Times, they’ve been a-changin’ for disease-modifying therapies. When I was diagnosed with multiple sclerosis in 1980, there were no DMTs. The first, the injectable Betaseron (interferon beta-1b), was approved by the U.S. Food and Drug Administration in 1993 for relapsing-remitting MS.
A few years later, I was thrilled to be included in the Phase 3 clinical trial of Avonex (interferon beta-1a), the second injectable, even though it required a self-injection into my calf once a week. Injectable DMTs were the only game in town until 2010, when a pill, Gilenya (fingolimod), received FDA approval.
Afterward, it seemed inevitable that, as a study in JAMA Neurology reported on July 10, the days of injectables being the first-prescribed MS treatments would be numbered.
The change from shots to pills
The Rutgers University study, based on data from U.S. health insurance companies, analyzed DMT prescribing patterns between 2001 and 2020. It involved 113,583 MS patients, each of whom started at least one DMT over those two decades. During that time period, prescribing an injectable medication as an adult’s first MS treatment declined a whopping 73.8%.
Pin the decline on pills. While oral treatments accounted for only 1.1% of the first DMT prescriptions being written in 2010, by the end of 2020 there were eight pills on the market — and they garnered 62.3% of the initial DMT orders.
Somewhat surprisingly to me, the study showed only a small (3.2%) demand for the highly effective infusions that became available starting in 2004, when Tysabri (natalizumab) was approved. That percentage began to increase after Ocrevus (ocrelizumab) was introduced in 2017, but it only rose to 8.2% by 2020, even though Lemtrada (alemtuzumab) had also become available.
It’s a lifestyle thing
The Rutgers research suggests several reasons for this preference for pills. They include efficacy, tolerability, safety, and cost — and the cost is often the elephant in the treatment room when treatments are being discussed. Wrap all of these things together and it adds up to lifestyle. As an MS News Today story about this research points out, oral DMTs “have provided an alternative, more convenient form of administration compared with injectable and infusion therapies.”
Over my 42 years of living with MS, I’ve been treated with four DMTs: Avonex, Tysabri, Aubagio (teriflunomide), and Lemtrada. Each helped me to live the best life possible with this illness, but my goal for each medication was slightly different.
Avonex gave me hope that there was finally a medication that might slow my relapses, and it did. Tysabri was an easy monthly infusion that solved the problem of needle fatigue, which I developed after a dozen years of self-injecting.
Aubagio allowed me to continue a DMT after my John Cunningham virus titer levels became concerning. As a pill, it was also the most convenient of the four treatments, but a change in my health insurance made Aubagio unaffordable.
That brought me to Lemtrada. Its efficacy was rated higher than my other three medications in a 2021 classification in the Journal of Comparative Effectiveness Research; its cost was covered by my Medicare insurance; and two series of infusions — each a year apart — fit my lifestyle. I was 68 years old, retired, and had lived with MS for 38 years when I began Lemtrada. I felt its benefits outweighed its risks, and my neurologist and I agreed that it would be my final DMT.
I’m sorry that more people with MS are not being started off with infusions as their treatment, especially because they’re considered to be among the most effective of the DMTs. The reason could be that regular infusions might not fit the lifestyle of many people or it could be fear of the side effects, but I suspect a lot of it has to do with that “elephant” in the treatment room — cost — and the unwillingness of health insurance companies and national health services to cover infusions as first-line treatments.
And that’s a shame.
(A version of this post first appeared as my column on the MS News Today website.)
(Image by Arek Socha from Pixabay)
