Treatment burden affects nearly 70% of ALS patients in Italian study

Treatment burden — the workload associated with managing a disease, including taking medications, attending medical appointments, and carrying out self-care tasks — was reported by nearly 70% of patients with amyotrophic lateral sclerosis (ALS), according to a study in Italy.

Among patients reporting any burden, more than half were experiencing moderate to high levels of treatment burden. Notably, greater treatment burden was associated with poorer quality of life and lower medication adherence, meaning patients were less likely to take medications as prescribed.

“The findings support the routine assessment of treatment burden as part of comprehensive ALS care,” the researchers wrote in the study, “Impact of treatment burden on medication adherence and quality of life in amyotrophic lateral sclerosis: a prospective multicentre study,” published in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration.

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Treatment workload can grow as ALS advances

ALS is a progressive neurodegenerative disease marked by worsening muscle weakness that can affect movement, speech, swallowing, and breathing. While treatments may help slow disease progression or manage symptoms, the demands associated with treatment can become increasingly challenging as the disease advances.

For example, swallowing difficulties may require medications to be crushed, mixed with liquids, or delivered through a feeding tube. These changes take more time and effort and can affect a person’s ability to take medications as prescribed.

To better understand treatment burden in ALS and its impact on patient outcomes, researchers from three ALS centers in Italy enrolled 114 patients. Assessments were conducted at the start of the study and again after six and 12 months when available.

Treatment burden was measured using the Multimorbidity Treatment Burden Questionnaire. Overall, 69.3% of patients reported some degree of treatment burden. Among them, 48.1% had low burden, 35.4% had moderate burden, and 16.5% had high burden.

When researchers compared these findings to clinical data, a greater treatment burden was associated with greater somatic symptom burden, which can include symptoms such as pain, fatigue, and sleep problems. The need to modify how medications were taken, such as crushing tablets because of swallowing difficulties, was also tied to treatment burden.

By contrast, treatment burden was not significantly associated with disease duration, disease progression rate, the severity of swallowing difficulties, coexisting medical conditions, or the number of medications patients were taking.

Higher burden linked to worse quality of life

Notably, patients with moderate or high treatment burden had significantly poorer quality of life than those with none-to-low burden, even after accounting for disease duration, somatic symptom severity, functional status, degree of swallowing difficulty, and rate of disease progression.

“The consistent link between burden and [quality of life] suggests that treatment workload should be considered in ALS clinical trial design,” the team wrote.

Higher treatment burden also was associated with lower medication adherence, and this link also remained significant after adjusting for disease-related factors.

Of the 68 patients who reached the one-year follow-up, 58 had available treatment-burden trajectory data. Among them, 41 had stable treatment burden throughout the study, while 17 moved to a higher burden category. No participants moved to a lower burden category during the study period.

Patients whose burden worsened over 12 months experienced a significantly larger decline in quality of life than those whose burden remained stable. Changes in treatment burden were not significantly associated with changes in medication adherence, though the researchers noted this may be partly due to the relatively small number of patients in this analysis.

Among participants who dropped out of the study, the most common reason was death (48.7%), followed by being lost to follow-up (43.6%) and withdrawal of consent (7.7%). Patients who dropped out tended to have had a higher treatment burden at the start of the study, though this difference was not statistically significant, meaning it could have occurred by chance.

“Treatment burden, particularly driven by drug formulation complexities and somatic symptoms, emerges as a pivotal, modifiable determinant of adherence and [quality of life] in ALS,” the researchers concluded. “Targeted interventions to alleviate modifiable burden components hold promise for optimizing clinical outcomes and enhancing patient-centred care.”