Patient Characteristics and Real-World Use of Botulinum Toxins for the Treatment of Cervical Dystonia, Blepharospasm, and Hemifacial Spasm
Abstract
:1. Introduction
2. Results
2.1. Patient Populations
2.2. BoNT Utilization
2.3. Potential AEs
3. Discussion
4. Conclusions
5. Materials and Methods
5.1. Data Source
5.2. Study Design
5.3. Patient Selection
5.4. Patient Characteristics
5.5. Treatment Utilization
5.6. Potential Adverse Events
5.7. Statistical Analyses
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Cervical Dystonia | Blepharospasm | Hemifacial Spasm | ||||
---|---|---|---|---|---|---|
INCO | Non-INCO Botulinum Toxin | INCO | Non-INCO Botulinum Toxin | INCO | Non-INCO Botulinum Toxin | |
N = 1547 | N = 17,355 | N = 1395 | N = 9257 | N = 798 | N = 7178 | |
Age | ||||||
Mean, SD | 58.83 (14.88) | 56.80 (15.18) | 67.36 (12.47) | 65.14 (13.56) | 66.66 (13.19) | 63.27 (14.48) |
Median, IQR | 60.00 [48.00, 70.00] | 57.00 [46.00, 68.00] | 69.00 [61.00, 76.00] | 67.00 [57.00, 75.00] | 68.00 [59.00, 76.00] | 66.00 [54.00, 74.00] |
<18 years (N, %) | - | - | - | - | 1 (0.1%) | 27 (0.4%) |
18–44 years (N, %) | 284 (18.4%) | 3868 (22.3%) | 82 (5.9%) | 802 (8.7%) | 55 (6.9%) | 811 (11.3%) |
45–64 years (N, %) | 650 (42.0%) | 7559 (43.6%) | 374 (26.8%) | 2882 (31.1%) | 216 (27.1%) | 2389 (33.3%) |
65+ years (N, %) | 613 (39.6%) | 5928 (34.2%) | 939 (67.3%) | 5573 (60.2%) | 526 (65.9%) | 3951 (55.0%) |
Sex (N, %) | ||||||
Male | 380 (24.6%) | 4124 (23.8%) | 444 (31.8%) | 2811 (30.4%) | 247 (31.0%) | 2186 (30.5%) |
Female | 1167 (75.4%) | 13,231 (76.2%) | 951 (68.2%) | 6446 (69.6%) | 551 (69.0%) | 4992 (69.5%) |
Race (N, %) | ||||||
Non-Hispanic White | 1301 (84.1%) | 14,430 (83.1%) | 1009 (72.3%) | 6878 (74.3%) | 532 (66.7%) | 5076 (70.7%) |
Non-Hispanic Black | 111 (7.2%) | 1185 (6.8%) | 121 (8.7%) | 703 (7.6%) | 73 (9.1%) | 542 (7.6%) |
Non-Hispanic Asian | 42 (2.7%) | 381 (2.2%) | 61 (4.4%) | 507 (5.5%) | 59 (7.4%) | 483 (6.7%) |
Hispanic | 93 (6.0%) | 1359 (7.8%) | 204 (14.6%) | 1169 (12.6%) | 134 (16.8%) | 1077 (15.0%) |
Other | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
Region (N, %) | ||||||
Northeast | 129 (8.3%) | 1981 (11.4%) | 130 (9.3%) | 1095 (11.8%) | 79 (9.9%) | 893 (12.4%) |
Midwest | 347 (22.4%) | 4069 (23.4%) | 283 (20.3%) | 2095 (22.6%) | 181 (22.7%) | 1802 (25.1%) |
South | 707 (45.7%) | 7096 (40.9%) | 693 (49.7%) | 3851 (41.6%) | 352 (44.1%) | 2718 (37.9%) |
West | 363 (23.5%) | 4193 (24.2%) | 289 (20.7%) | 2209 (23.9%) | 185 (23.2%) | 1753 (24.4%) |
Other | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (0.0%) |
Unknown | 1 (0.1%) | 16 (0.1%) | 0 (0.0%) | 7 (0.1%) | 1 (0.1%) | 11 (0.2%) |
Co-Medications at Index Date (60 Days Before to 30 Days After) (N, %) | ||||||
Aminoglycoside antibiotics and spectinomycin | 2 (0.1%) | 56 (0.3%) | 3 (0.2%) | 20 (0.2%) | 3 (0.4%) | 13 (0.2%) |
Parenterally administered drugs that interfere with neuromuscular transmission | 5 (0.3%) | 90 (0.5%) | 3 (0.2%) | 33 (0.4%) | 2 (0.3%) | 36 (0.5%) |
Aminoquinolines | 25 (1.6%) | 264 (1.5%) | 20 (1.4%) | 86 (0.9%) | 3 (0.4%) | 76 (1.1%) |
Anticholinergic drugs | 1228 (79.4%) | 14,207 (81.9%) | 936 (67.1%) | 6331 (68.4%) | 516 (64.7%) | 4771 (66.5%) |
Anticoagulants | 69 (4.5%) | 865 (5.0%) | 63 (4.5%) | 495 (5.3%) | 47 (5.9%) | 352 (4.9%) |
Peripheral muscle relaxants | 453 (29.3%) | 5326 (30.7%) | 113 (8.1%) | 850 (9.2%) | 75 (9.4%) | 692 (9.6%) |
Co-Medications after Index Date (N, %) * | ||||||
Aminoglycoside antibiotics and spectinomycin | 10 (0.6%) | 147 (0.8%) | 8 (0.6%) | 81 (0.9%) | 7 (0.9%) | 53 (0.7%) |
Parenterally administered drugs that interfere with neuromuscular transmission | 12 (0.8%) | 261 (1.5%) | 15 (1.1%) | 119 (1.3%) | 2 (0.3%) | 82 (1.1%) |
Aminoquinolines | 27 (1.7%) | 276 (1.6%) | 17 (1.2%) | 118 (1.3%) | 1 (0.1%) | 90 (1.3%) |
Anticholinergic drugs | 861 (55.7%) | 10,444 (60.2%) | 662 (47.5%) | 5539 (59.8%) | 397 (49.7%) | 4095 (57.0%) |
Anticoagulants | 76 (4.9%) | 1068 (6.2%) | 74 (5.3%) | 797 (8.6%) | 44 (5.5%) | 571 (8.0%) |
Peripheral muscle relaxants | 381 (24.6%) | 4661 (26.9%) | 124 (8.9%) | 1168 (12.6%) | 69 (8.6%) | 856 (11.9%) |
Previous Botulinum Toxin Use Any Time Prior to Index Date (N, %) | ||||||
INCO | 405 (26.2%) | 0 (0.0%) | 380 (27.2%) | 0 (0.0%) | 170 (21.3%) | 0 (0.0%) |
OnabotulinumtoxinA | 486 (31.4%) | 6151 (35.4%) | 613 (43.9%) | 4015 (43.4%) | 376 (47.1%) | 2953 (41.1%) |
RimabotulinumtoxinB | 51 (3.3%) | 307 (1.8%) | 16 (1.1%) | 48 (0.5%) | - | - |
AbobotulinumtoxinA | 32 (2.1%) | 184 (1.1%) | 8 (0.6%) | 40 (0.4%) | 8 (1.0%) | 26 (0.4%) |
Any | 772 (49.9%) | 6483 (37.4%) | 850 (60.9%) | 4058 (43.8%) | 477 (59.8%) | 2965 (41.3%) |
Cervical Dystonia | Blepharospasm | Hemifacial Spasm | ||||
---|---|---|---|---|---|---|
INCO | Non-INCO Botulinum Toxin | INCO | Non-INCO Botulinum Toxin | INCO | Non-INCO Botulinum Toxin | |
N = 1218 | N = 11,243 | N = 1002 | N = 5154 | N = 567 | N = 3973 | |
Follow-Up, Person-Years | ||||||
Mean per person, SD | 0.85 (0.98) | 0.94 (1.23) | 0.88 (1.03) | 1.23 (1.64) | 0.91 (1.03) | 1.15 (1.54) |
Median, IQR | 0.53 [0.31, 1.04] | 0.51 [0.31, 1.04] | 0.49 [0.31, 1.02] | 0.57 [0.31, 1.47] | 0.54 [0.31, 1.10] | 0.55 [0.31, 1.33] |
Number of Injections | ||||||
Mean number of injections per person, SD | 3.28 (3.66) | 3.56 (4.61) | 3.35 (3.90) | 4.54 (6.16) | 3.35 (3.76) | 4.16 (5.57) |
Median, IQR | 2.00 [1.00, 4.00] | 2.00 [1.00, 4.00] | 2.00 [1.00, 4.00] | 2.00 [1.00, 5.00] | 2.00 [1.00, 4.00] | 2.00 [1.00, 5.00] |
Mean number of injections per person-year, SD | 2.24 (1.25) | 2.18 (1.22) | 2.17 (1.29) | 2.27 (1.27) | 2.17 (1.20) | 2.20 (1.20) |
Median, IQR | 2.00 [1.00, 3.30] | 2.00 [1.00, 3.16] | 2.00 [1.00, 3.01] | 2.00 [1.00, 3.34] | 2.00 [1.00, 3.14] | 2.00 [1.00, 3.23] |
Weeks between Injections | ||||||
Number of patients with more than 1 injection | 708 (58.1%) | 6424 (57.1%) | 554 (55.3%) | 3055 (59.3%) | 326 (57.5%) | 2316 (58.3%) |
Mean number of average weeks between injections per person, SD | 14.51 (3.10) | 14.73 (3.45) | 15.13 (4.01) | 15.41 (4.08) | 15.64 (3.92) | 15.65 (3.94) |
Median, IQR | 13.81 [13.00, 15.60] | 13.86 [13.00, 15.86] | 14.14 [13.00, 16.50] | 14.44 [13.06, 17.07] | 14.43 [13.25, 16.78] | 14.64 [13.19, 17.23] |
Switching * (N, %) | ||||||
Number of patients with an administration of a non-incobotulinumtoxinA BoNT during follow-up | 147 (12.1%) | 142 (1.3%) | 143 (14.3%) | 36 (0.7%) | 83 (14.6%) | 10 (0.3%) |
OnabotulinumtoxinA use | 131 (10.8%) | 135 (13.5%) | 81 (14.3%) | |||
RimabotulinumtoxinB use | 4 (0.3%) | 2 (0.2%) | ||||
AbobotulinumtoxinA use | 12 (1.0%) | 6 (0.6%) | 2 (0.4%) | |||
OnabotulinumtoxinA on index date and switch to AbobotulinumtoxinA | 50 (0.4%) | 12 (0.2%) | 7 (0.2%) | |||
OnabotulinumtoxinA on index date and switch to RimabotulinumtoxinB | 32 (0.3%) | 10 (0.2%) | ||||
AbobotulinumtoxinA on index date and switch to OnabotulinumtoxinA | 25 (0.2%) | 7 (0.1%) | 3 (0.1%) | |||
AbobotulinumtoxinA on index date and switch to RimabotulinumtoxinB | 1 (0.0%) | 0 (0.0%) | ||||
RimabotulinumtoxinB on index date and switch to OnabotulinumtoxinA | 29 (0.3%) | 7 (0.1%) | ||||
RimabotulinumtoxinB on index date and switch to AbobotulinumtoxinA | 5 (0.0%) | 0 (0.0%) |
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Hast, M.A.; Kong, A.M.; Desai, S.; Back, S.; Syed, S.; Holmes, J. Patient Characteristics and Real-World Use of Botulinum Toxins for the Treatment of Cervical Dystonia, Blepharospasm, and Hemifacial Spasm. Toxins 2024, 16, 362. https://doi.org/10.3390/toxins16080362
Hast MA, Kong AM, Desai S, Back S, Syed S, Holmes J. Patient Characteristics and Real-World Use of Botulinum Toxins for the Treatment of Cervical Dystonia, Blepharospasm, and Hemifacial Spasm. Toxins. 2024; 16(8):362. https://doi.org/10.3390/toxins16080362
Chicago/Turabian StyleHast, Michael A., Amanda M. Kong, Shaina Desai, Soo Back, Sahar Syed, and Jordan Holmes. 2024. "Patient Characteristics and Real-World Use of Botulinum Toxins for the Treatment of Cervical Dystonia, Blepharospasm, and Hemifacial Spasm" Toxins 16, no. 8: 362. https://doi.org/10.3390/toxins16080362