Patient Perspectives on the Therapeutic Profile of Botulinum Neurotoxin Type A in Spasticity

Abstract

Background: Botulinum toxin-A (BoNT-A) injections are first-line treatment for adult spasticity. Prior patient surveys have reported that BoNT-A treatment improves quality of life but that symptoms usually recur before the next injection. We aimed to explore, in-depth, patient perceptions of the impact of spasticity and the waning of BoNT-A therapeutic effects. Methods: An internet-based survey was conducted through Carenity, an online patient community, from May to September 2019 in France, Germany, Italy, UK and USA. Eligible respondents were adult patients with spasticity due to stroke, traumatic brain injury (TBI) or spinal cord injury (SCI) who had ≥2 previous BoNT-A injections. Results: Two hundred and ten respondents (mean 47.2 years) met screening criteria and had their responses analyzed. Overall, 43% of respondents had spasticity due to stroke, 30% due to TBI and 27% due to SCI. The mean [95% CI] injection frequency for spasticity management was 3.6 [3.4-3.7] injections/year. Respondents described the time profile of their response to BoNT-A. The mean reported onset of therapeutic effect was 12.9 [12.1-13.7] days and the mean time to peak effect was 5.0 [4.7-5.4] weeks. Symptom re-emergence between injections was common (83%); the time from injection to symptom re-emergence was 89.4 [86.3-92.4] days. Muscle spasms usually re-emerge first (64%), followed by muscle stiffness or rigidity (40%), and limb pain (20%). Over half (52%) of respondents said they had lost their self-confidence, 46% experienced depression and 41% experienced a lack of sleep due to their spasticity symptoms in the past 12 months. Following a report of symptom re-emergence, the most common management approaches were to add adjunctive treatments (36%), increase the BoNT-A dose (28%), and wait for the next injection (26%). Seventy two percentage of respondents said they would like a longer lasting BoNT-A treatment. Conclusions: Patients with spasticity can expect a characteristic profile of BoNT-A effects, namely time lag to onset and peak effect followed by a gradual decline in the symptomatic benefits. Symptom re-emergence is common and has significant impact on quality of life. Greater patient/clinician awareness of this therapeutic profile should lead to better level of overall satisfaction with treatment, informed therapeutic discussions and treatment schedule planning.

Keywords: botulinum toxin; patient perspectives; patient survey; spasticity; waning of effect.

Figure 1

Current therapy for spasticity (other than BoNT-A). Which treatments are you currently receiving for your spasticity? (N = 210), *Oral medications such as muscle relaxant or baclofen. Overall, 97% respondents were currently receiving BoNT-A and 3% had stopped within the year prior to the survey.

Figure 2

Therapeutic effects of BoNT-A. Schematic representing the mean [95% CI] time to onset, peak therapeutic effect and time to symptom re-emergence. Respondents were asked: On average, how many days or weeks after your BoNT-A injections do you experience. ^aThe first effect of the treatment on your spasticity ^bthe maximum effects of the treatment on your spasticity (in days or weeks). In general, how long after your BoNT- A injections do your pre-existing symptoms begin to reappear. *Respondents were also asked to indicate the time between the last two sessions of Botulinum Toxin A [multichoice question].

Figure 3

Frequency of re-emergent symptoms by etiology. Among the following pre-existing symptoms, could you select the ones which reappear between two sessions of BoNT-A injections in their order of reappearance?

Figure 4

Severity of symptoms over a typical BoNT-A injection cycle. At these 3 different points of treatment [peak effect, waning of effect, just prior to next injection], how would you rate the intensity of your symptoms? n = 174 respondents whose symptoms reappear between two sessions of injections.

Figure 5

Impact of symptom re-emergence in past year. During the past 12 months, at the worst time, which of the following situations have you experienced as a consequence of your spasticity? n = 210 respondents.

Figure 6

Impact of symptom re-emergence on professional life (working patients). How does the reappearance of your spasticity pre-existing symptoms between two sessions of BoNT-A injections affect your work?, n = 133 respondents who are currently working and whose symptoms reappear between two sessions.

Figure 7

Impact of spasticity on patient quality of life over a typical BoNT-A injection cycle. At these 3 different points of treatment [peak effect, waning of effect, just prior to next injection], how would you rate the impact of spasticity on your quality of life?, n = 174 respondents whose symptoms reappear between two sessions of injections.

Figure 8

Respondent wish for improved BoNT-A treatment. What improvements with your BoNT-A treatment do you want in order to avoid reappearance of symptoms between sessions of injections?, n = 169 respondents whose symptoms reappear between two sessions of injections.