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February 8, 2026Scientific Reports3 citationsOpen Access

A real-world, multicentre, epidemiological study in Czech and Slovak adults with spinal muscular atrophy treated with risdiplam

OPOlesja ParmováKPKrystof PrasilLMLenka Mokrá

Key Result

Risdiplam was associated with early improvements in upper-limb function maintained for 2–3 years, no loss of motor function, and no initiation of ventilation in adults with 5q-SMA.

Key Points

  • This study aims to analyze the outcomes of risdiplam therapy in adults with 5q spinal muscular atrophy.
  • Multicenter epidemiological study involving 59 adults with genetically confirmed 5q-SMA
  • Evaluated outcomes using RULM, HFMSE, and forced vital capacity at multiple time points
  • Collected follow-up data for up to 36 months
  • No patient lost motor function throughout the follow-up period
  • RULM scores improved in the first 6 months and remained stable thereafter
  • Overall motor function showed stability, with non-significant mean increases in HFMSE
  • Forced vital capacity remained stable and no patients required ventilatory support

Study Design

Type

Observational (n=59)

Multicenter

Yes

Structured PICO

Does risdiplam stabilize or improve motor and respiratory function in adults with 5q-SMA?

P
Population
59 adults with genetically confirmed 5q-SMA (median age 28.5 years, 57.6% male; 57.6% type 2, 33.9% type 3, 8.5% type 1; 90.6% wheelchair users) from the Czech Republic and Slovakia.
I
Intervention
Risdiplam administered in routine clinical practice.
O
Outcome
Changes in RULM, HFMSE, FVC % predicted, and ventilation status at baseline and at Month 6, 12, 24, and up to 36.

In advanced adult SMA patients, risdiplam was associated with sustained upper-limb improvement, overall motor stability over 3 years, and a favourable respiratory trajectory without the need for new ventilation.

Main Result

Effect estimate: RULM increased by 0.02 points per month (p=0.079), HFMSE increased by 0.05 points per month (p=0.222)

Limitations

  • Observational design without predefined statistical analysis plan; statistical analyses are exploratory.
  • Missing data and incomplete follow-up at all timepoints; decreasing patient numbers at later visits.
  • FVC measurement variability and limited sensitivity for respiratory compromise; lacked broader respiratory parameters.
  • Registry comorbidity categories are broad and may not capture SMA-specific complications adequately.
  • Missing data (not all patients had results at every time point, not all completed 36 months)
  • Reliance on FVC alone for respiratory outcomes
  • Extreme variability of FVC percentage
  • Comorbidity fields in registry not tailored to SMA-specific complications
  • Exploratory statistical tests without predefined statistical analysis plan

Abstract

Real-world evidence about risdiplam therapy in adults with 5q spinal muscular atrophy (SMA) remains limited to outcomes in small cohorts, heterogeneous endpoints, and a short follow-up. We collected data of 59 adults with genetically confirmed 5q-SMA treated with risdiplam and analysed RULM, HFMSE, FVC % predicted, and ventilation status at baseline and at Month 6, 12, 24, and up to 36. The cohort comprised 59 adults (median age 28.5 years, range 17.0-59.2; 57.6% type 2, 33.9% type 3, and 8.5% type 1; 90.6% wheelchair users). During the follow-up period no patient lost motor function. RULM improved during the first 6 months and remained stable through 24-36 months. Over the follow-up, HFMSE showed a non-significant mean monthly increase of 0.05 points (P = 0.222), and RULM increased by 0.02 points per month (P = 0.079). No patient initiated ventilation during follow-up and forced vital capacity remained stable. In our adult population, including Type 1 survivors, risdiplam was associated with sustained upper-limb improvement, overall motor stability over 3 years, and a favourable respiratory trajectory without ventilation. Our findings indicate that stabilisation is a clinically meaningful target in advanced adult SMA patients.

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Cite This Study

Parmová et al. (2026) conducted an observational in Adults with genetically confirmed 5q spinal muscular atrophy (SMA) Types 1, 2, or 3, mostly wheelchair-bound, median age 28.5 years (n=59). risdiplam was evaluated on Change in motor function assessed by Revised Upper Limb Module (RULM), Hammersmith Functional Motor Scale - Expanded (HFMSE), forced vital capacity (FVC % predicted), and ventilation status over 36 months (RULM increased by 0.02 points per month (p=0.079), HFMSE increased by 0.05 points per month (p=0.222)). Risdiplam was associated with early improvements in upper-limb function maintained for 2–3 years, no loss of motor function, and no initiation of ventilation in adults with 5q-SMA.

synapsesocial.com/papers/698828d90fc35cd7a8848a51https://doi.org/10.1038/s41598-026-37462-6
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