Gilenya generic safe and effective, adherence good: Real-world study

A generic equivalent of oral Gilenya (fingolimod) significantly lowers relapse rates, slows disability progression, and works against new lesions developing in people with relapsing multiple sclerosis (MS), according to a real-world study in Turkey.

Feedback from patients also was favorable, with most being satisfied with the generic treatment and adhering to it well.

The study, “Use of follow-on fingolimod for multiple sclerosis: Analysis of effectiveness and patient reported outcomes in a real-world clinical setting,” was published in the journal Multiple Sclerosis and Related Disorders.

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Gilenya, a once-daily oral medicine marketed by Novartis, is approved widely to treat adults and children who have relapsing forms of MS, where symptoms appear or worsen and then fade or go away.

It works by trapping immune cells and keeping them from traveling toward the brain and spinal cord, limiting the damage they cause in MS. This can help to lower the number of relapses and delay disability worsening.

As patents for Gilenya expire, generics are becoming available in many countries. Generics are usually less expensive versions of a brand-name medication. They contain the same active substance as their approved reference medicine, and are used at the same dose for the same patient group.

Because generics are expected to work and provide clinical benefits equal to their reference drug, their approval usually depends on clinical studies of the brand-name medicine, along with laboratory studies demonstrating that the active ingredient behaves in the same way for both medications. Real-world data, for these reasons, are important for confirming how well they work and how safe they really are for patients.

Researchers in Turkey drew on real-world data covering 239 people with relapsing forms of MS, ages 18 to 65, treated for at least one year with a Gilenya generic approved by the Turkish Ministry of Health in 2017.

Women made up most of this group (175 patients or 73.2%), which had a mean age of 38.7. Patients had been using fingolimod, the generic, for an average of 2.5 years. Many of these people — 221 patients — switched to fingolimod from another disease-modifying therapy, usually the injection therapies interferon-beta 1a or 1b and glatiramer acetate.

Most (79.5%) had at least one relapse in the year before starting with fingolimod. In contrast, 13.4% experienced a relapse after one year of fingolimod treatment. The annualized relapse rate, a measure of the number of relapses per year, significantly decreased from 1 to 0.2, the researchers reported.

The average number of days on high-dose methylprednisolone, a corticosteroid often used as a first line of treatment for severe relapses, also fell from 5.2 to 0.9. This suggests that relapses were less severe while on treatment with the fingolimod generic.

Gilenya (fingolimod) generic’s use often led to stable EDSS scores

Average scores on the Expanded Disability Status Scale (EDSS) decreased from 2.3 points at the time of fingolimod initiation to 2.1 points after one year of its use, indicating an easing in disability. A significant decrease to 2.2 points was observed as early as after six months with fingolimod, the researchers noted.

While on fingolimod, 196 (82%) had no change in EDSS scores, 34 (14.2%) improved, and nine (3.8%) worsened. Those who worsened had more severe disability in the year before treatment compared with those who improved or showed stable scores.

Fewer new and active lesions on MRI scans of the brain and spinal cord also were recorded.

Of the 214 patients who responded to a 12-item satisfaction and adherence questionnaire, in the process of being validated in Turkey, 137 (64%) showed satisfaction by not responding negatively to its statements and questions. These included statements like “I think the drug I used is treating me” or “I feel better after I start using the drug,” with patients asked to agreed or disagreed, strongly agreed or disagreed, or state they’ve no opinion.

Fifty patients (23.4%) consulted their doctor due to treatment side effects, mostly for how the treatment affected their physical or mental state. Sixteen patients (7.5%) reported memory loss, 26 (12.1%) reported feeling more tired, and four (1.9%) feeling “moodier.”

Treatment adherence was high, with 129 patients (71.5%) reporting never missing a monthly dose, while 24 noted missing a dose once in a month.

Generic’s efficacy and safety ‘in line’ with previous Gilenya clinical trials

Bradycardia, or a slowed heart rate that can occur after a first fingolimod dose, was observed in 11 (4.6%) patients. Elevated liver enzymes, a sign of liver damage, occurred in two patients (0.8%), and two also had low lymphocyte levels, a type of immune cell.

Among 21 patients (8.8%) who stopped fingolimod after a mean 1.8 years, most (15 people) did so because of a relapse. Other reasons were abnormal levels of liver enzymes or lymphocytes (2 patients), while the four others stopped for reasons ranging from tuberculosis meningitis and cancer to pregnancy and choice.

“This study presents real-world data retrospectively evaluating the efficacy and safety of one of the [generics] prescribed in Turkey,” the researchers wrote, emphasizing that “long-term post-marketing real-life data are necessary to maintain confidence” in these MS treatments.

“Analysis of data from 239 [MS patients] with high disease activity and with a long follow-up … revealed that the efficacy and safety results were in line with previous studies of the brand drug,” they concluded, with high adherence and satisfaction shown.

Generics, however, “need to be therapeutically equivalent to their reference product” to ensure patient safety, they added.