safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)safetyrisk-89Research ArticleОБЗОРЫ И ОРИГИНАЛЬНЫЕ СТАТЬИREVIEWS AND ORIGINAL ARTICLESБезопасность применения апремиласта: риск возникновения психических нарушенийSafety of apremilast: risk of psychical disordersБукатинаТ. М.BukatinaT. M.noemail@neicon.ruВельцН. Ю.VeltsN. Yu.noemail@neicon.ruДармостуковаМ. А.DarmostukovaM. A.noemail@neicon.ruПастернакЕ. Ю.PasternakE. Yu.noemail@neicon.ruРомановаТ. В.RomanovaT. V.noemail@neicon.ruНаучный центр экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation20172002201854182187Copyright © Букатина Т.М., Вельц Н.Ю., Дармостукова М.А., Пастернак Е.Ю., Романова Т.В., 20182018Букатина Т.М., Вельц Н.Ю., Дармостукова М.А., Пастернак Е.Ю., Романова Т.В.Bukatina T.M., Velts N.Y., Darmostukova M.A., Pasternak E.Y., Romanova T.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/89

Апремиласт - новый низкомолекулярный селективный ингибитор фосфодиэстеразы 4 (ФДЭ4), используемый для терапии псориатического артрита и псориаза. Эффективность и безопасность применения апремиласта при лечении бляшковидного псориаза средней и тяжелой степени тяжести были доказаны в многоцентровых рандомизированных двойных-слепых плацебо-контролируемых клинических исследованиях ESTEEM 1 и ESTEEM 2 (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis). В данных исследованиях описываются нежелательные реакции со стороны психики: депрессия, суицидальные мысли, суицидальное поведение. Однако доказательств повышения частоты развития данных нежелательных реакций при более длительном лечении апремиластом не было получено. В статье представлены сообщения регуляторного органа Великобритании (MHRA) и международной базы данных VigiBase о возросшем риске развития суицидальных мыслей, попыток суицида, завершенных суицидов и суицидального поведения на фоне приема апремиласта.

Apremilast is a new selective inhibitor of phosphodiesterase 4 (PDE4) of the class of small molecules, approved for treatment of psoriatic arthritis and psoriasis. The efficacy and safety of apremilast in the treatment of moderate to severe plaque psoriasis have been demonstrated in multicenter, randomized, double-blind, placebo-controlled clinical trials of ESTEEM 1 and ESTEEM 2 (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis). These studies describe adverse reactions such as mental disorders: depression, suicidal thoughts, suicidal behavior. However, data on the increase in the incidence of these adverse reactions during longer treatment with apremilast were not obtained. The article presents the reports from the UK regulator (MHRA) and international database VigiBase on the increased risk of developing suicidal thoughts, suicide attempts, completed suicides and suicidal behavior during treatment with apremilast.

ингибиторы фосфодиэстеразы 4препараты класса малых молекулапремиластнарушения психикисуицидальные мыслисуицидальные наклонностисуицидальное поведениеinhibitors of phosphodiesterase 4Aprimilastpsychical disorderssuicidal ideationsuicide attemptcompleted suicidesuicidal behaviorReferencesАстахова АВ, Лепахин ВК. Неблагоприятные побочные реакции и контроль безопастности лекарств: руководство по фармаконадзору. М.: Когито-Центр; 2004.Astakhova AV, Lepakhin VC. Adverse Reactions and Control of DragSafety: A Guide to Pharmacovigilance. Moscow: Kogito-Center; 2004.Олефир ЮВ, Верлан НВ, Романов БК, Двойникова НА, Кочкина ЕО. Проблемы мониторинга безопасности фармакотерапии. М.: Фолиум; 2017.Olefir SE, Verlan NV, Romanov BC, Dvojnikova NA, Kochkina EO. Problems monitoring the safety of pharmacotherapy. Moscow: Folium, 2017.Журавлева М. В., Кукес В. Г., Прокофьев А. Б., Архипов В. В., Олефир Ю. В., Сереброва С. Ю. и др. Эффективность и безопасность применения лекарственных средств: значение и возможности клинической фармакологии. Ведомости Научного центра экспертизы средств медицинского применения 2015; (2): 20-24.Zhuravleva MV, Kukes VG, Prokofiev AB, Arkhipov VV, Olefir YuV, Serebrova SYu, et al. Efficacy and safety of medicines: the value and opportunities of clinical pharmacology. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal products 2015; (2): 20 — 24.Fala L. Otezla (Apremilast), an Oral PDE-4 Inhibitor, Receives FDA Approval for the Treatment of Patients with Active Psoriatic Arthritis and Plaque Psoriasis. American Health Drug Benefits. 2015 Mar; 8(Spec Feature): 105-110.Fala L. Otezla (Apremilast), an Oral PDE-4 Inhibitor, Receives FDA Approval for the Treatment of Patients with Active Psoriatic Arthritis and Plaque Psoriasis. American Health Drug Benefits. 2015 Mar; 8(Spec Feature): 105–110.Young M, Heather L. Roebuck. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor: A novel treatment option for nurse practitioners treating patients with psoriatic disease. Jounal of the American Association of Nurse Practitioners. 2016 Dec; 28(12): 683-695.Young M, Heather L. Roebuck. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor: A novel treatment option for nurse practitioners treating patients with psoriatic disease. Jounal of the American Association of Nurse Practitioners. 2016 Dec; 28(12): 683–695.Dattola A, Del Duca E, Saraceno R, Gramiccia T, Bianchi L. Safety evaluation of apremilast for the treatment of psoriasis. Expert Opin Drug Saf. 2017 Mar;16(3):381-385.Dattola A, Del Duca E, Saraceno R, Gramiccia T, Bianchi L. Safety evaluation of apremilast for the treatment of psoriasis. Expert Opin Drug Saf. 2017 Mar; 16(3): 381–385.Gisondi P, Girolomoni G. Apremilast in the therapy of moderate-to-severe chronic plaque psoriasis. Drug Design, Development and Therapy. 2016; 10: 1763-1770.Gisondi P, Girolomoni G. Apremilast in the therapy of moderate-to-severe chronic plaque psoriasis. Drug Design, Development and Therapy. 2016; 10: 1763–1770.Torres T, Puig L. Apremilast: A Novel Oral Treatment for Psoriasis and Psoriatic Arthritis. Am J Clin Dermatol. 2017 Jun 8.Torres T, Puig L. Apremilast: A Novel Oral Treatment for Psoriasis and Psoriatic Arthritis. Am J Clin Dermatol. 2017 Jun 8.Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodi-esterase 4 inhibitor, in patients with moderate to severe plaque psoriasis: results of a phase III, randomized, controlled trial (ESTEEM 1) J Am Acad Dermatol. 2015;73:37-49.Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodi-esterase 4 inhibitor, in patients with moderate to severe plaque psoriasis: results of a phase III, randomized, controlled trial (ESTEEM 1) J Am Acad Dermatol. 2015; 73: 37–49.Reich K, Papp K, Gordon K, et al. Long-term safety and tolerability of apremilast in patients with psoriasis: pooled safety analysis of two phase 3, randomized, controlled trials (ESTEEM 1 and 2); Presented at: Annual Congress of the European Academy of Dermatology and Venereology; October 8-12, 2014; Amsterdam, The Netherlands.Reich K, Papp K, Gordon K, et al. Long-term safety and tolerability of apremilast in patients with psoriasis: pooled safety analysis of two phase 3, randomized, controlled trials (ESTEEM 1 and 2); Presented at: Annual Congress of the European Academy of Dermatology and Venereology; October 8–12, 2014; Amsterdam, The Netherlands.Letters sent to healthcare professionals in November 2016 (14.12.2016 г.). [Электронный ресурс]. URL: https://www.gov.uk/drug-safety-update.Letters sent to healthcare professionals in November 2016 (14.12.2016 ã.). [Electronic resource]: URL: https://www.gov.uk/drug-safety-update.

The authors declare that there are no conflicts of interest present.