Key result
MRI-guided needle muscle biopsies were associated with significantly higher pain scores compared to outpatient clinic Bergström needle biopsies (median NRS 7 vs 4, p=0.001).
Why the study?
With the expected increase in muscle biopsies for upcoming FSHD clinical trials, the patient experience and burden of these procedures needed assessment.
Does MRI-guided needle muscle biopsy cause more pain and burden compared to outpatient clinic Bergström needle biopsy in patients with FSHD?
Cross-Sectional (n=49)
Does MRI-guided needle muscle biopsy cause more pain and burden compared to outpatient clinic Bergström needle biopsy in patients with FSHD?
MRI-guided muscle biopsies are associated with a higher patient burden and pain compared to outpatient clinic Bergström needle biopsies in FSHD patients.
May favor Bergström over MRI-guided biopsies to reduce pain in FSHD; observational data leaves preference open for prospective trials.
Muscle biopsies are used in clinical trials to measure target engagement of the investigational product. With many upcoming therapies for patients with facioscapulohumeral dystrophy (FSHD), the frequency of biopsies in FSHD patients is expected to increase. Muscle biopsies were performed either in the outpatient clinic using a Bergström needle (BN-biopsy) or in a Magnetic Resonance Imaging machine (MRI-biopsy). This study assessed the FSHD patients' experience of biopsies using a customized questionnaire. The questionnaire was sent to all FSHD patients who had undergone a needle muscle biopsy for research purposes, inquiring about biopsy characteristics and burden, and willingness to undergo a subsequent biopsy. Forty-nine of 56 invited patients (88%) completed the questionnaire, reporting on 91 biopsies. The median pain score (scale 0-10) during the procedure was 5 [2-8], reducing to 3 [1-5] and 2 [1-3] after one and 24 h, respectively. Twelve biopsies (13.2%) resulted in complications, eleven resolved within 30 days. BN-biopsies were less painful compared to MRI-biopsies (median NRS: 4 [2-6] vs. 7 [3-9], p = 0.001). The burden of needle muscle biopsies in a research setting is considerate and should not be underestimated. MRI-biopsies have a higher burden compared to BN-biopsies.
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Kools et al. (2023) conducted a cross-sectional in Facioscapulohumeral muscular dystrophy (FSHD) (n=49). MRI-guided needle muscle biopsy vs. Outpatient clinic Bergström needle biopsy was evaluated on Pain score during the procedure (p=0.001). MRI-guided needle muscle biopsies were associated with significantly higher pain scores compared to outpatient clinic Bergström needle biopsies (median NRS 7 vs 4, p=0.001).
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