Resumen
Introducción: las toxinas botulínicas son medicamentos bioterapéuticos con grandes aplicaciones en el campo de la neurología, como la cefalea y los movimientos anormales. Debido a la importancia médica y al incremento de las indicaciones terapéuticas de la toxina botulínica, este artículo pretende hacer claridad acerca de la terminología básica con respecto a la naturaleza de este medicamento, a las diferencias estructurales con medicamentos convencionales y aspectos importantes en relación con su potencia biológica e inmunogenicidad, para así comprender las potenciales diferencias entre las toxinas disponibles y conceptuar en torno a la no intercambiabilidad o sustitución de una toxina por otra.
Materiales y métodos: revisión no sistemática, según lo recomendado en la Escala para la Verificación de los Artículos Revisiones Narrativas (Sanra).
Conclusiones: los medicamentos biológicos no son intercambiables entre sí, aunque demuestren bioequivalencia. No cumplen con la definición de biosimilar de la FDA; no se pueden evaluar como medicamentos genéricos intercambiables porque son biológicos; no existen estudios comparativos cabeza a cabeza; son diferentes, debido al proceso individual de manufactura.
Citas
Baethge C, Goldbeck-Wood S, Mertens S. SANRA - a scale for the quality assessment of narrative review articles. Res Integr Peer Rev. 2019;4:5. https://doi.org/10.1186/s41073-019-0064-8
U.S. Food & Drug Administration (FDA). Biosimilar and interchangeable products [consultado el 19 de junio del 2022]. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products#generic
Verrill M, Declerck P, Loibl S, Lee J, Cortes J. The rise of oncology biosimilars: from process to promise. Future Oncol. 2019;15(28):3255-65. https://doi.org/10.2217/fon-2019-0145
Biosimilars info sheet. Generics and biosimilars. https://www.fda.gov/media/154912/download
U.S. Food & Drug Administration (FDA). Biosimilar product information [consultado el 19 de abril del 2021]. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
European Medicines Agency. Medicines type-biosimilars [consultado el 26 de abril del 2021]. https://www.ema.europa.eu/en/medicines/search_api_aggregation_ema_medicine_types/field_ema_med_biosimilar
Gherghescu I, Delgado-Charro MB. The biosimilar landscape: an overview of regulatory approvals by the EMA and FDA. Pharmaceutics. 2021;13(1):48. https://doi.org/10.3390/pharmaceutics13010048
Kresse GB. Biosimilars - science, status, and strategic perspective. Eur J Pharm Biopharm. 2009;72(3):479-86. https://doi.org/10.1016/j.ejpb.2009.02.014
Chiu SY, Burns MR, Malaty IA. An update on botulinum toxin in neurology. Neurol Clin. 2021;39(1):209-29. https://doi.org/10.1016/j.ncl.2020.09.014
Burstein R, Blumenfeld AM, Silberstein SD, Manack Adams, A, Brin MF. Mechanism of action of onabotulinumtoxinA in chronic migraine: a narrative review. Headache. 2020;60:1259-72. https://doi.org/10.1111/head.13849
Davletov B, Bajohrs M, Binz T. Beyond Botox: Advantages and limitations of individual botulinum neurotoxins. Trends Neurosci. 2005;28(8):446-52. https://doi.org/10.1016/j.tins.2005.06.001
Chen R, Karp BI, Goldstein SR, Bara-Jimenez W, Yaseen Z, Hallett M. Effect of muscle activity immediately after botulinum toxin injection for writer's cramp. Mov Disord. 1999;14(2):307-12. https://doi.org/10.1002/1531-8257(199903)14:2<307::AID-MDS1016>3.0.CO;2-3
Eleopra R, Tugnoli V, De Grandis D. The variability in the clinical effect induced by botulinum toxin type A: The role of muscle activity in humans. Mov Disord. 1997;12(1):89-94. https://doi.org/10.1002/mds.870120115
Rosales RL, Arimura K, Takenaga S, Osame M. Extrafusal and intrafusal muscle effects in experimental botulinum toxin-A injection. Muscle Nerve. 1996;19(4):488-96. https://doi.org/10.1002/(SICI)1097-4598(199604)19:4%3C488::AID-MUS9%3E3.0.CO;2-8
Trompetto C, Currà A, Buccolieri A, Suppa A, Abbruzzese G, Berardelli A. Botulinum toxin changes intrafusal feedback in dystonia: a study with the tonic vibration reflex. Mov Disord. 2006;21(6):777-82. https://doi.org/10.1002/mds.20801
Ramachandran R, Lam C, Yaksh TL. Botulinum toxin in migraine: Role of transport in trigemino-somatic and trigemino-vascular afferents. Neurobiol Dis. 2015;79:111-22. https://doi.org/10.1016/j.nbd.2015.04.011
Pellett S, Yaksh TL, Ramachandran R. Current status and future directions of botulinum neurotoxins for targeting pain processing. Toxins. 2015;7(11):4519-63. https://doi.org/10.3390/toxins7114519
Zhang X, Strassman AM, Novack V, Brin MF, Burstein R. Extracranial injections of botulinum neurotoxin type A inhibit intracranial meningeal nociceptors’ responses to stimulation of TRPV1 and TRPA1 channels: Are we getting closer to solving this puzzle? Cephalalgia. 2016;36(9):875-86. https://doi.org/10.1177/0333102416636843
Smith TJ, Hill KK, Raphael BH. Historical and current perspectives on Clostridium botulinum diversity. Res Microbiol. 2015;166(4):290-302. https://doi.org/10.1016/j. resmic.2014.09.007
Dashtipour K, Chen JJ, Espay AJ, Mari Z, Ondo W. Onabotulinumtoxin A and abobotulinumtoxin A dose conversion: a systematic literature review. Mov Disord Clin Pract. 2016;3(2):109-15. https://doi.org/10.1002/mdc3.12235 .
Scaglione F. Conversion ratio between Botox®, Dysport®, and Xeomin® in clinical practice. Toxins (Basel). 2016;8(3):65. https://doi.org/10.3390/toxins8030065
Brin MF, James C, Maltman J. Botulinum toxin type A products are not interchangeable: a review of the evidence. Biologics. 2014;8:227-41. https://doi.org/10.2147/BTT.S65603
Car H, Bogucki A, Bonikowski M, Dec-?wiek M, Dru?d? A, Koziorowski D, et al. Botulinum toxin type-A preparations are not the same medications - basic science (part 1). Neurol Neurochir Pol. 2021;55:133-40. https://doi.org/10.5603/PJNNS.a2021.0027
Becker WJ. Botulinum toxin in the treatment of headache. Toxins (Basel). 2020;12(12):803. https://doi.org/10.3390/toxins12120803
Bentivoglio AR, Del Grande A, Petracca M, Ialongo T, Ricciardi L. Clinical differences between botulinum neurotoxin type A and B. Toxicon. 2015;107(Pt A):77-84. https://doi.org/10.1016/j.toxicon.2015.08.001
Fonfria E, Maignel J, Lezmi S, Martin V, Splevins A, Shubber S, et al. the expanding therapeutic utility of botulinum neurotoxins. Toxins. 2018;10(5):208. https://doi.org/10.3390/toxins10050208
Allergan I. Package insert, Botox (botulinum toxin type A purified neurotoxin complex). Madison, NJ: Irvine Allergan; 2019.
Merz Pharmaceuticals. Package insert, Xeomin (incobotulinumtoxintype A). Frankfurt: Merz Pharmaceuticals GmbH; 2018.
Solstice Neurosciences. Package Insert, Myobloc (botulinum toxin type B injectable solution). Louisville (KY): Solstice Neurosciences, LLC; 2019.
Ipsen. Package insert, Dysport (abobotulinumtoxin A). Basking Ridge (NJ): Ipsen Biopharmaceuticals; 2019.
Field M, Splevins A, Picaut P, van der Schans M, Langenberg J, Noort D, et al. AbobotulinumtoxinA (Dysport®), OnabotulinumtoxinA (Botox®), and IncobotulinumtoxinA (Xeomin®) Neurotoxin content and potential implications for duration of response in patients. Toxins (Basel). 2018;10(12):535. https://doi.org/10.3390/toxins10120535
Wenzel R, Jones D, Borrego JA. Comparing two botulinum toxin type A formulations using manufacturers’ product summaries. J Clin Pharm Ther. 2007;32(4):387-402. https://doi.org/10.1111/j.1365-2710.2007.00835.x
Rupp D, Nicholson G, Canty D, Wang J, Rhéaume C, Le L, et al. OnabotulinumtoxinA displays greater biological activity compared to IncobotulinumtoxinA, demonstrating non-interchangeability in both in vitro and in vivo assays. Toxins (Basel). 2020;12(6):393. https://doi.org/10.3390/toxins12060393
Hunt T, Clarke K. Potency evaluation of a formulated drug product containing 150-kd botulinum neurotoxin type A. Clin Neuropharmacol. 2009;32(1):28-31. https://doi.org/10.1097/WNF.0b013e3181692735
Brown M, Nicholson G, Ardila MC, Satorius A, Broide RS, Clarke K, et al. Comparative evaluation of the potency and antigenicity of two distinct BoNT/A-derived formulations. J Neural Transm. 2013;120(2):291-8. https://doi.org/10.1007/s00702-012-0854-3
Hunt T, Clarke K, Rupp D, Shimizu G, Weidler J. 50-U incobotulinumtoxinA drug product demonstrates lower potency when compared to 50-U onabotulinumtoxinA drug product with concurrent lower light-chain activity and atypical substrate cleavage; Poster presented at 6th European Master’s in Aesthetic and Anti-Aging Medicine; October 15–17, 2010; París, Francia.
Aurora SK, Dodick DW, Turkel CC, DeGryse RE, Silberstein SD, Lipton RB, et al; PREEMPT 1 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the Preempt 1 trial. Cephalalgia. 2010;30(7):793-803. https://doi.org/10.1177/0333102410364676
Diener HC, Dodick DW, Aurora SK, Turkel CC, DeGryse RE, Lipton RB, et al; PREEMPT 2 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the Preempt 2 trial. Cephalalgia. 2010;30(7):804-14. https://doi.org/10.1177/0333102410364677
Chankrachang S, Arayawichanont A, Poungvarin N, Nidhinandana S, Boonkongchuen P, Towanabut S, et al. Prophylactic botulinum type A toxin complex (Dysport®) for migraine without aura. Headache. 2011;51(1):52-63. https://doi.org/10.1111/j.1526-4610.2010.01807.x
Simpson DM, Hallett M, Ashman EJ, Comella CL, Green MW, Gronseth GS, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016;86(19):1818-26. https://doi.org/10.1212/WNL.0000000000002560
Jackson JL, Kuriyama A, Hayashino Y. Botulinum toxin A for prophylactic treatment of migraine and tension headaches in adults: a meta-analysis. JAMA. 2012;307(16):1736-45. https://doi.org/10.1001/jama.2012.505
Shamliyan TA, Kane RL, Taylor FR. Migraine in adults: preventive pharmacologic treatments. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013.
Tassorelli C, Sances G, Avenali M, De Icco R, Martinelli D, Bitetto V, et al. Botulinum toxin for chronic migraine: Clinical trials and technical aspects. Toxicon. 2018;147:111-5. https://doi.org/10.1016/j.toxicon.2017.08.026
Bellows S, Jankovic J. Immunogenicity associated with botulinum toxin treatment. Toxins (Basel). 2019;11(9):491. https://doi.org/10.3390/toxins11090491
Albrecht P, Jansen A, Lee JI, Moll M, Ringelstein M, Rosenthal D, et al. High prevalence of neutralizing antibodies after long-term botulinum neurotoxin therapy. Neurology. 2019;92(1):e48-54. https://doi.org/10.1212/WNL.0000000000006688
Lange O, Bigalke H, Dengler R, Wegner F, deGroot M, Wohlfarth K. Neutralizing antibodies and secondary therapy failure after treatment with botulinum toxin type A: much ado about nothing?. Clin Neuropharmacol. 2009;32(4):213-8. https://doi.org/10.1097/WNF.0b013e3181914d0a
Naumann M, Carruthers A, Carruthers J, Aurora SK, Zafonte R, Abu-Shakra S, et al. Meta-analysis of neutralizing antibody conversion with onabotulinumtoxinA (Botox(R)) across multiple indications. Mov Disord. 2010;25(13):2211-8. https://doi.org/10.1002/mds.23254
Gelb DJ, Yoshimura DM, Olney RK, Lowenstein DH, Aminoff MJ. Change in pattern of muscle activity following botulinum toxin injections for torticollis. Ann Neurol. 1991;29(4):370-6. https://doi.org/10.1002/ana.410290407
Dressler D. Clinical presentation and management of antibody-induced failure of botulinum toxin therapy. Mov Disord. 2004;19 Suppl 8:S92-S100. https://doi.org/10.1002/mds.20022
Fabbri M, Leodori G, Fernandes RM, Bhidayasiri R, Marti MJ, Colosimo C, et al. Neutralizing antibody and botulinum toxin therapy: a systematic review and meta-analysis. Neurotox Res. 2016;29(1):105-17. https://doi.org/10.1007/s12640-015-9565-5
Brashear A, Bergan K, Wojcieszek J, Siemers ER, Ambrosius W. Patients’ perception of stopping or continuing treatment of cervical dystonia with botulinum toxin type A. Mov Disord. 2000;15(1):150-3. https://doi.org/10.1002/1531-8257(200001)15:1%3C150::AID-MDS1024%3E3.0.CO;2-X
Srinoulprasert Y, Wanitphakdeedecha R. Antibody-induced botulinum toxin treatment failure: A review and novel management approach. J Cosmet Dermatol. 2020;19(10):2491-6. https://doi.org/10.1111/jocd.13637
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