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Observational Study
. 2024 Dec;31(12):e16409.
doi: 10.1111/ene.16409. Epub 2024 Sep 5.

Patient-reported daily functioning after SARS-CoV-2 vaccinations in autoimmune neuromuscular diseases

Koos P J van Dam  1 , Luuk Wieske  1   2 , Eileen W Stalman  1 , Laura Y L Kummer  1   3 , Anneke J van der Kooi  1 , Joost Raaphorst  1 , Diederik van de Beek  1 , Jan J G M Verschuuren  4 , Annabel M Ruiter  4 , Esther Brusse  5 , Pieter A van Doorn  5 , Adája E Baars  5 , W Ludo van der Pol  6 , H Stephan Goedee  6 , Anja Ten Brinke  6 , S Marieke van Ham  3   7 , Theo Rispens  3 , Taco W Kuijpers  8 , Filip Eftimov  1 ; T2B! Immunity Against SARS‐CoV‐2 Study Group
Affiliations
Observational Study

Patient-reported daily functioning after SARS-CoV-2 vaccinations in autoimmune neuromuscular diseases

Koos P J van Dam et al. Eur J Neurol. 2024 Dec.

Abstract

Background and purpose: There are concerns for safety regarding SARS-CoV-2 vaccines for patients with autoimmune neuromuscular disease. We compared daily functioning using disease-specific patient-reported outcome measures (PROMs) before and after SARS-CoV-2 vaccinations.

Methods: In this substudy of a prospective observational cohort study (Target-to-B!), patients with myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy (MMN), and idiopathic inflammatory myopathy (IIM) vaccinated against SARS-CoV-2 were included. Surveys of daily functioning (Myasthenia Gravis Activities of Daily Living, Inflammatory Rasch-Built Overall Disability Scale, Multifocal Motor Neuropathy Rasch-Built Overall Disability Scale, and Health Assessment Questionnaire-Disability Index) were sent before first vaccination and every 60 days thereafter for up to 12 months. Regression models were constructed to assess differences in PROM scores related to vaccination, compared to scores unrelated to vaccination. We also assessed the proportion of patients with deterioration of at least the minimal clinically important difference (MCID) between before first vaccination and 60 days thereafter.

Results: We included 325 patients (median age = 59 years, interquartile range = 47-67, 156 [48%] female sex), of whom 137 (42%) had MG, 79 (24%) had CIDP, 43 (13%) had MMN, and 66 (20%) had IIM. PROM scores related to vaccination did not differ from scores unrelated to vaccination. In paired PROMs, MCID for deterioration was observed in three of 49 (6%) MG patients, of whom none reported a treatment change. In CIDP, MCID for deterioration was observed in eight of 29 patients (28%), of whom two of eight (25%) reported a treatment change.

Conclusions: SARS-CoV-2 vaccination had no effect on daily functioning in patients with autoimmune neuromuscular diseases, confirming its safety in these patients.

Keywords: SARS‐CoV‐2; neuromuscular disease; patient‐reported outcome measures; symptom flare‐up; vaccination.

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Conflict of interest statement

F.E. and T.W.K. report (governmental) grants from ZonMw to study immune response after SARS‐Cov‐2 vaccination in autoimmune diseases. F.E. also reports grants from Prinses Beatrix Spierfonds, CSL Behring, Kedrion, Terumo BCT, Grifols, Takeda Pharmaceutical Company, and GBS‐CIDP Foundation; consulting fees from UCB Pharma and CSl Behring; and honoraria from Grifols. A.J.v.d.K. reports grants from CSL Behring and participation on an advisory board for Argenx. J.J.G.M.V. reports consulting fees from Argenx, Alexion, and NMD Pharma and is coinventor on patent applications based on MuSK‐related research. P.A.v.D. has received research grants from Prinses Beatrix Spierfonds, the Netherlands Organisation for Health Research and Development (ZonMW), Sanquin, Takeda, and Grifols. He is a member of scientific advisory committee/steering committee trials for Annexon, Argenx, Hansa, Octapharma, Sanofi, and Roche. All grants and fees were paid to his institution. H.S.G. is a board member of the Dutch Society of Clinical Neurophysiology (unpaid), reports grants from Prinses Beatrix Spierfonds, and has received speaker fees from Shire/Takeda. W.L.v.d.P. reports grants from Prinses Beatrix Spierfonds, stichting Spieren voor Spieren, Vriendenloterij, and EU Horizon 2020 and has participated on scientific advisory boards for Argenx, Biogen, and Novartis gene therapies. None of the other authors has any conflict of interest to disclose.

Figures

FIGURE 1
FIGURE 1
Study flowchart describing the selection of participants for the analysis. T2B!, Target‐to‐B!.
FIGURE 2
FIGURE 2
Disease‐specific patient‐reported outcome measure (PROM) scores for autoimmune neuromuscular diseases related or unrelated to recent SARS‐Cov‐2 vaccination. Figure shows boxplots of all PROM scores during follow‐up as included in the linear mixed model for (a) myasthenia gravis, (b) chronic inflammatory demyelinating polyneuropathy, (c) multifocal motor neuropathy, and (d) idiopathic inflammatory myopathy, from surveys related to vaccination (defined as surveys completed within 8–60 days after any SARS‐CoV‐2 vaccination) and surveys unrelated to vaccination (defined as surveys without prior vaccination, or vaccination >60 days prior to the survey). Dots represent individual scores, with measurements from the same participant in the same color. In the Myasthenia Gravis Activities of Daily Living (MG‐ADL) and Health Assessment Questionnaire–Disability Index (HAQ‐DI), a low score indicates better daily functioning, whereas in the Inflammatory Rasch‐Built Overall Disability Scale (I‐RODS) and Multifocal Motor Neuropathy Rasch‐Built Disability Scale (MMN RODS), a high score indicates better daily functioning.
See this image and copyright information in PMC

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