Abstract
Symptoms of cervical dystonia (CD) can vary in severity and cause significant pain. OnabotulinumtoxinA is an approved treatment for CD. This study assessed health-related quality of life (HRQoL) in patients with CD who received multiple onabotulinumtoxinA treatments. This prospective, observational standard-of-care study was conducted at multiple neurology centers in Québec, Canada. Patients reported the health impact of CD using the Cervical Dystonia Impact Profile (CDIP)-58, before and after up to eight onabotulinumtoxinA treatments. Other measures included the Cervical Dystonia Severity Rating Scale by physician, employment status using the Work Productivity Questionnaire and pain using the Pain Numeric Rating Scale (PNRS). Adverse events (AEs) were recorded. Sixty-two patients were enrolled (safety population, n = 61; modified efficacy population, n = 58). Participants were mostly females who were employed; most (79.3%) had torticollis. In all, 21/62 patients (33.9%) discontinued the study. At the final visit, there was a statistically significant (p < 0.001) improvement in all eight CDIP-58 subscales, particularly head and neck symptoms (-31.0) and psychosocial functioning (-28.2). Employment increased from baseline (55%) to the end of the study (64%), and there was improvement in work productivity. There was a significant (p < 0.0001) reduction in pain measured by the PNRS, from -0.5 post-treatment 1 to -2.4 at end of study. AEs (neck pain, muscular weakness, dysphagia, nausea) were consistent with onabotulinumtoxinA use. These real-world data indicate that after repeated, long-term use, onabotulinumtoxinA continues to be a safe and effective treatment for CD, improving HRQoL and work productivity.
Highlights
Symptoms of cervical dystonia (CD) can vary in severity and cause significant pain
Adjudication by an independent safety committee of each episode of dysphagia determined that these events did not represent a distant spread of toxin. This multi-center, prospective, observational standard-of-care study evaluated the impact of treatment with onabotulinumtoxinA on CD using patient-reported outcomes
Significant improvements in CD symptoms were reported on all eight Cervical Dystonia Impact Profile (CDIP)-58 subscales, and on all three CDIP-58 conceptual domains, improvements were consistent across all disease severities
Summary
Symptoms of cervical dystonia (CD) can vary in severity and cause significant pain. OnabotulinumtoxinA is an approved treatment for CD. The prevalence of CD has been estimated to be in the range of 20 to 4100 cases per million individuals, and it occurs more commonly in women than in men.[4] The neck may move in several ways; in rotational torticollis, the sternocleidomastoid, splenius capitis, and obliquus capitis muscles are typically involved, whereas other more complex movements such as tilting (laterocollis) or forward (anterocollis) or backward (retrocollis) bending of the neck involve other muscle groups.[5] The most common presentation of CD is torticollis, followed by laterocollis, retrocollis, and anterocollis, but the majority of patients experience a combination of deviations.[6] Pain is the main reason for patients seeking treatment, with up to 90% of patients reporting pain associated with CD that greatly affects their quality of life (QoL).[7,8] Symptoms can range from mild to severe and have significant economic impact on the patient; CD has been reported to cause loss of employment in 18.9% to 38.5% of patients.[9,10]
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