Safety profile of ocrelizumab for the treatment of multiple sclerosis: a systematic review

References

• Leary S, Porter B, Thompson A. Multiple sclerosis: diagnosis and the management of acute relapses. Postgrad Med J. 2005;81:302–308.
   PubMed Web of Science ®Google Scholar
• Amankwah N, Marrie RA, Bancej C, et al. Multiple sclerosis in Canada 2011 to 2031: results of a microsimulation modelling study of epidemiological and economic impacts. Health Promot Chronic Dis Prev Can. 2017;37:37–48.
   PubMed Web of Science ®Google Scholar
• Feigin VL, Abajobir AA, Abate KH, et al. Global, regional, and national burden of neurological disorders during 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017;16:877–897.
   PubMed Web of Science ®Google Scholar
• Wallin MT, Culpepper WJ, Campbell JD, et al. The prevalence of MS in the United States: a population-based estimate using health claims data. Neurology. 2019;92:e1029–e40.
   PubMed Web of Science ®Google Scholar
• Reich DS, Lucchinetti CF, Calabresi PA. Multiple sclerosis. N Engl J Med. 2018;378:169–180.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Salter A, Wallström E, et al. Evolution of clinical trials in multiple sclerosis. Ther Adv Neurol Disord. 2019;12:1–14.
   Web of Science ®Google Scholar
• FDA News Release. FDA approves new drug to treat multiple sclerosis. 2017 [cited 2020 Apr 3]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treat-multiple-sclerosis
   Google Scholar
• Kappos L, Li D, Calabresi PA, et al. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011;378:1779–1787.
   PubMed Web of Science ®Google Scholar
• Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376:221–234.
   PubMed Web of Science ®Google Scholar
• Montalban X, Hauser SL, Kappos L, et al. Ocrelizumab versus placebo in primary progressive multiple sclerosis. N Engl J Med. 2017;376:209–220.
   PubMed Web of Science ®Google Scholar
• Mulero P, Midaglia L, Montalban X. Ocrelizumab: a new milestone in multiple sclerosis therapy. Ther Adv Neurol Disord. 2018;11:1–6.
   Web of Science ®Google Scholar
• Zorzela L, Loke YK, Ioannidis JP, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ. 2016;352:i157.
   PubMedGoogle Scholar
• Higgins JPT, Thomas J, Chandler J, et al., editors. Cochrane handbook for systematic reviews of interventions version 6.0. Cochrane, 2019 [cited 2020 July 8]. Available from: www.training.cochrane.org/handbook.
   Google Scholar
• Peryer G, Golder S, Junqueira DR, et al. Chapter 19: adverse effects. In: Higgins JPT, Thomas J, Chandler J, et al., editors. Cochrane handbook for systematic reviews of interventions version 6.0. Cochrane, 2019 [cited 2020 July 8]. Available from: www.training.cochrane.org/handbook
   Google Scholar
• U.S. Department of Health and Human Services. Common terminology criteria for adverse events (CTCAE). Version 5.0. 2017 [cited 2020 Apr 3]. Available from: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf
   Google Scholar
• U.S. Food and Drug Administration. What is a serious adverse event? FDA; 2016 [cited 2020 Apr 3]. Available from: https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event
   Google Scholar
• Song A, Hendricks R, Chung S, et al. Immunogenicity with repeated dosing of ocrelizumab in patients with multiple sclerosis. Neurology. 2016;86:P2.087.
   PubMed Web of Science ®Google Scholar
• Jakimovski D, Weinstock-Guttman B, Ramanathan M, et al. Ocrelizumab: a b-cell depleting therapy for multiple sclerosis. Expert Opin Biol Ther. 2017;17:1163–1172.
   PubMed Web of Science ®Google Scholar
• European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). ECTRIMS Online Library. 2020 [cited 2020 Apr 3]. Available from: https://onlinelibrary.ectrims-congress.eu/ectrims/
   Google Scholar
• American Academy of Neurology (AAN). AAN annual meeting online abstract. 2020 [cited 2020 Jul 8]. Available from: https://index.mirasmart.com/AAN2020/index.php
   Google Scholar
• The Cochrane Collaboration. Review Manager (RevMan) [Computer program]. Version 5.3. 2019.
   Google Scholar
• Hartung HP. ENSEMBLE Steering Committee members and study investigators. Ocrelizumab shorter infusion: primary results from the ENSEMBLE PLUS substudy in patients with MS. Neurol Neuroimmunol Neuroinflamm. 2020;7:e807.
   PubMedGoogle Scholar
• Bar-Or A, Gelfand J, Fiore D, et al. Interim analysis of the OBOE (Ocrelizumab Biomarker Outcome Evaluation) study in multiple sclerosis (MS). Neurology. 2018;90:S24.002.
   PubMed Web of Science ®Google Scholar
• Leist TP, Reder AT, Bermel R, et al. Year one interim analysis results of the Phase IIIb CHORDS study evaluating ocrelizumab effectiveness and safety in patients with relapsing-remitting multiple sclerosis who had suboptimal response with prior disease-modifying treatments (P635). Mult Scler. 2018;24:318.
   Web of Science ®Google Scholar
• Vermersch P, Eralinna JP, Nicholas R, et al. Efficacy and safety of ocrelizumab in patients with relapsing-remitting multiple sclerosis with a suboptimal response to previous disease-modifying therapies (1-year interim results) (P690). Mult Scler. 2019;25:344.
   PubMedGoogle Scholar
• Vollmer T, Alvarez E, Nair KV, et al. Safety results for administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing multiple sclerosis (P1406). Mult Scler. 2019;25:778.
   Web of Science ®Google Scholar
• Baklan M, Tuncel R, Ekmekci O, et al. Adverse effects of monoclonal antibodies in patients with multiple sclerosis: a real world experience (EP 1586). Mult Scler. 2019;25:881.
   Web of Science ®Google Scholar
• Beckmann Y, Uzunköprü C. A real world data of ocrelizumab in multiple sclerosis (EPO1240). Eur J Neurol. 2020;27:671.
   Google Scholar
• Belcher S, Edwards K, Willams T, et al. Reduction of infusion related reactions during ocrelizumab infusions in a comprehensive multiple sclerosis care center (P1257). Mult Scler. 2018;24:717–718.
   Web of Science ®Google Scholar
• Bewick C, Das E, Collins J, et al. The incidence of infusion associated reactions in ocrelizumab-treated relapsing-remitting multiple sclerosis patients (EPO1260). Eur J Neurol. 2020;27:684–684.
   Web of Science ®Google Scholar
• Bolling J, Vasquez M, Sollero CEV, et al. Real-world experience with ocrelizumab - a safety analysis. Neurology. 2020;94:4199.
   Web of Science ®Google Scholar
• Chang L, Jehle L, Simkover R, et al. Association of immunoglobulin levels, risk of infections with use of ocrelizumab in MS patients (P1387). Mult Scler. 2019;25:766.
   PubMed Web of Science ®Google Scholar
• Conte WL, Arndt N, Cipriani VP, et al. Reduction in ocrelizumab-induced infusion reactions by a modified premedication protocol. Mult Scler Relat Disord. 2019;27:397–399.
   PubMed Web of Science ®Google Scholar
• Ellwardt E, Rolfes L, Klein J, et al. Ocrelizumab initiation in patients with MS: a multicenter observational study. Neurol Neuroimmunol Neuroinflamm. 2020;7:e719.
   PubMed Web of Science ®Google Scholar
• Evertsson B, Hoyt T, Christensen A, et al. Comparative study of tolerability and effects on immunoglobulin levels and CD19 cell counts with ocrelizumab vs rituximab in multiple sclerosis (P979). Mult Scler. 2019;25:515–516.
   PubMed Web of Science ®Google Scholar
• Fruns M, Scherpenisse J, Hornung G. Ocrelizumab in patients with multiple sclerosis. Descriptive study of a case series in Chile (0137). Mult Scler. 2019;25:171–172.
   Google Scholar
• Goldschmidt C, Rensel M, Mahajan K, et al. A retrospective chart review of the safety and tolerability in ocrelizumab in pediatric and young-adult onset multiple sclerosis. Neurology. 2020;94:4568.
   Web of Science ®Google Scholar
• Harding K, Ingram G, Horton E, et al. Early real-world experience of ocrelizumab in MS (179). J Neurol Neurosurg Psychiatry. 2019;90:e8.
   Web of Science ®Google Scholar
• Kolb C, Eckert S, Hojnacki D, et al. Safety and efficacy of ocrelizumab in multiple sclerosis patients with increased disability. Neurology. 2018;90:P6.353.
   PubMed Web of Science ®Google Scholar
• Lapucci C, Frau J, Cocco E, et al. Short-term safety and efficacy of switching from alemtuzumab to ocrelizumab in MS patients with disease activity after two alemtuzumab courses: an Italian multicentric, real-life study (EPO2263). Eur J Neurol. 2020;27:929–929.
   Web of Science ®Google Scholar
• Law L, Lin T, Do L, et al. Optimizing a center’s post-marketing experience with an infusible treatment: ocrelizumab for MS (P1414). Mult Scler. 2019;25:783.
   PubMed Web of Science ®Google Scholar
• Levin SN, Ezuma C, Levine L, et al. Switching from natalizumab to ocrelizumab in patients with multiple sclerosis. Mult Scler. 2020. DOI:10.1177/1352458520927631.
   PubMed Web of Science ®Google Scholar
• Madrid-Paredes A, Alvarez-Sanchez R, Nieto-Gomez P, et al. Effectiveness and safety of ocrelizumab in patients with multiple sclerosis. Int J Clin Phar. 2020;42:287–287.
   Web of Science ®Google Scholar
• Moss B, Parrotta E, Baldassari L, et al. Real-world experience with ocrelizumab (P1409). Mult Scler. 2019;25:780–781.
   Google Scholar
• Novi G, Cellerino M, Nesi L, et al. Ocrelizumab in an expanded cohort of primary progressive MS patients: safety outcomes and clinical/paraclinical follow-up (EP1596). Mult Scler. 2018;24:901–902.
   Web of Science ®Google Scholar
• Prockl V, Nickel FT, Utz KS, et al. Real world application of ocrelizumab in multiple sclerosis: single-center experience of 128 patients. J Neurol Sci. 2020;415:116973.
   PubMed Web of Science ®Google Scholar
• Sequeira J, Parra J, Brum M, et al. Ocrelizumab in a real-world primary progressive multiple sclerosis portuguese population (EPII019). Neurol Ther. 2019;8:S12.
   Google Scholar
• Signoriello E, Bonavita S, Di Pietro A, et al. BMI influences CD20 kinetics in multiple sclerosis patients treated with ocrelizumab. Mult Scler Relat Disord. 2020;43:102186.
   PubMed Web of Science ®Google Scholar
• Smoot K, Stuchiner T, Lucas L, et al. Utilization, safety, and tolerability of ocrelizumab: year 2 data from the providence ocrelizumab registry (P1011). Mult Scler. 2019;25:534–535.
   Web of Science ®Google Scholar
• Smoot K, Chen C, Gervasi-Follmar T, et al. Evaluating the efficacy and safety of transitioning patients from natalizumab to ocrelizumab (OCTAVE). Neurology. 2019;92:P3.2–056.
   Web of Science ®Google Scholar
• Tran V, Miller PA, Jarrar R, et al. Real world efficacy and safety profile of ocrelizumab therapy in patients with multiple sclerosis (EP1557). Mult Scler. 2019;25:864.
   Google Scholar
• van Hall V, Hartung H-P, Dirks P, et al. Assessing the long-term outcomes of ocrelizumab treatment in Germany - CONFIDENCE baseline characteristics (EP1559). Mult Scler. 2019;25:865.
   Web of Science ®Google Scholar
• Vollmer B, Nair K, Sillau S, et al. Ocrelizumab real-world safety and effectiveness in the one year treatment of multiple sclerosis compared to other disease modifying therapies (P1357). Mult Scler. 2019;25:747–748.
   Google Scholar
• Vural E, Terzi M, Sunter G, et al. Real-life outcomes of ocrelizumab treatment from 3 multiple sclerosis centers in Turkey (P1364). Mult Scler. 2019;25:751.
   Google Scholar
• Zappulo E, Buonomo AR, Saccà F, et al. Incidence and predictive risk factors of infective events in patients with multiple sclerosis treated with agents targeting CD20 and CD52 surface antigens. Open Forum Infect Dis. 2019;6:ofz445.
   PubMed Web of Science ®Google Scholar
• Akram A, Valasek M, Patel D. De novo colitis after ocrelizumab therapy (P096). Gastroenterology. 2020;158:S1–S2.
   Web of Science ®Google Scholar
• Auer M, Bsteh G, Hegen H, et al. Late-onset neutropenia in a multiple sclerosis patient after first dose ocrelizumab switched from rituximab. Mult Scler Relat Disord. 2020;43:102155.
   PubMed Web of Science ®Google Scholar
• Bouchachi S, Hillen M. Should elderly MS patients follow conventional dosing of ocrelizumab? Neurology. 2020;94:4669.
   Web of Science ®Google Scholar
• Chin LD, AbuHilal M. Ocrelizumab-induced alopecia areata- a series of five patients from Ontario, Canada: a case report. SAGE Open Med Case Rep. 2020;8:1–3.
   Web of Science ®Google Scholar
• Ciardi MR, Iannetta M, Zingaropoli MA, et al. Reactivation of hepatitis b virus with immune-escape mutations after ocrelizumab treatment for multiple sclerosis. Open Forum Infect Dis. 2019;6. DOI:10.1093/ofid/ofy356.
   PubMed Web of Science ®Google Scholar
• Claunch J, Stanton K, Valizadeh N, et al. Two cases of atypical psychiatric presentations after ocrelizumab induction with near complete resolution (P614). Mult Scler. 2018;24:303–304.
   Web of Science ®Google Scholar
• Clifford DB, Gass A, Richert N, et al. Cases reported as progressive multifocal leukoencephalopathy in ocrelizumab-treated patients with multiple sclerosis (P970). Mult Scler J. 2019;25:509.
   Web of Science ®Google Scholar
• Cohen BA. Late-onset neutropenia following ocrelizumab therapy for multiple sclerosis. Neurology. 2019;92:435–436.
   PubMed Web of Science ®Google Scholar
• Darwin E, Romanelli P, Lev-Tov H. Ocrelizumab-induced psoriasiform dermatitis in a patient with multiple sclerosis. Dermatol Online J. 2018;24:1–3.
   Google Scholar
• Dudek MIR, Thies K, Kammenhuber S, et al. HSV-2-encephalitis in a patient with multiple sclerosis treated with ocrelizumab. J Neurol. 2019;266:2322–2323.
   PubMed Web of Science ®Google Scholar
• Fa issnerS, Schwake C, Gotzmann M, et al. Endocarditis following ocrelizumab in relapsing-remitting MS. Neurol Neuroimmunol Neuroinflamm. 2020;7:e680.
   PubMed Web of Science ®Google Scholar
• Fast J, Miller PA, Miravalle A, et al. HPV infection in an MS patient treated with ocrelizumab therapy. Mult Scler. 2020;26:62–63.
   Web of Science ®Google Scholar
• Hernández-Echebarría L, Luque AA, Martinez ER, et al. Severe reactivation of rheumatic cardiopathy during treatment with ocrelizumab. Neurology. 2020;94:2111.
   Web of Science ®Google Scholar
• Kadish R, Robertson D, Sweeney M. Fatal leukoencephalopathy in a patient with multiple sclerosis following treatment with ocrelizumab. Neurology. 2018;90:P5.353.
   Google Scholar
• Lattanzi S, Carlini G, Acciarri MC, et al. Parvovirus B19 infection in a patient with multiple sclerosis treated with ocrelizumab. Acta Neurol Belg. 2020;120:231–232.
   PubMed Web of Science ®Google Scholar
• Meca-Lallana V, Aguirre C, Sanchez P, et al. Neutropenia associated with ocrelizumab in a multiple sclerosis progresive patient (EP1583). Mult Scler. 2019;25:879.
   PubMed Web of Science ®Google Scholar
• Moreira Ferreira VF, Meredith D, Stankiewicz JM. Tumefactive demyelination in a patient with relapsing-remitting MS on ocrelizumab. Neurol Neuroimmunol Neuroinflamm. 2019;6:e589.
   PubMed Web of Science ®Google Scholar
• Moreira Ferreira VF, Kimbrough DJ, Stankiewicz JM. A possible case of serum sickness after ocrelizumab infusion. Mult Scler. 2020. DOI:10.1177/1352458520910486
   PubMed Web of Science ®Google Scholar
• Nassau Clements S, Banta E. Successful desensitization of two patients with immediate hypersensitivity reactions to ocrelizumab (M058). Ann Allergy Asthma Immunol. 2019;123:S79–S80.
   Web of Science ®Google Scholar
• Nicolini LA, Canepa P, Caligiuri P, et al. Fulminant hepatitis associated with echovirus 25 during treatment with ocrelizumab for multiple sclerosis. JAMA Neurol. 2019;76:866–867.
   PubMed Web of Science ®Google Scholar
• Novi G, Ivaldi F, Sbragia E, et al. Ocrelizumab does not impair B- and T-cell responses to primary VZV infection in a patient with MS. Neurol Neuroimmunol Neuroinflamm. 2020;7:e695.
   PubMed Web of Science ®Google Scholar
• Nylund M, Vuorinen T, Airas L. Drug reaction with eosinophilia and systemic symptoms after ocrelizumab therapy. Mult Scler Relat Disord. 2020;42:102058.
   PubMed Web of Science ®Google Scholar
• Pala VK, Sianati B, Scott T. Rapid onset drug induced neutropenia associated with ocrelizumab in multiple sclerosis. Neurology. 2020;94:4919.
   Web of Science ®Google Scholar
• Sul J, Patel A, Gordon ML, et al. Progressive multifocal leukoencephalopathy in a patient on ocrelizumab monotherapy. Neurology. 2020;94:4875.
   Web of Science ®Google Scholar
• Theriault M, Solomon AJ. Two cases of meningitis associated with ocrelizumab therapy. Mult Scler Relat Disord. 2020;38:101866.
   PubMed Web of Science ®Google Scholar
• Trivedi A, Tsang J, Gounder M, et al. Succesful desensitisation to ocrelizumab in a patient with multiple sclerosis and IgE-mediated hypersensitivity. Intern Med J. 2019;49:33–33.
   Web of Science ®Google Scholar
• Zanetta C, Robotti M, Nozzolillo A, et al. Late onset absolute neutropenia associated with ocrelizumab treatment in multiple sclerosis: a case report and review of the literature. J Neurol Sci. 2020;409:116603.
   PubMed Web of Science ®Google Scholar
• F. Hoffmann La-Roche Ltd. Ocrelizumab and fatalities. 2020 [cited 2020 Jul 8]. Available from: https://www.ocrelizumabinfo.global/en/homepage/additional-topics-of-interest/fatalities.html
   Google Scholar
• F. Hoffmann La-Roche Ltd. Ocrelizumab and PML. 2020 [cited 2020 Jul 8]. Available from: https://www.ocrelizumabinfo.global/en/homepage/additional-topics-of-interest/progressive-multifocal.html
   Google Scholar
• F. Hoffmann La-Roche Ltd. Ocrelizumab and malignancies. 2020 [cited 2020 Jul 8]. https://www.ocrelizumabinfo.global/en/homepage/additional-topics-of-interest/malignancies.html
   Google Scholar
• F. Hoffmann La-Roche Ltd. Ocrelizumab and infections. 2020 [cited 2020 Jul 8]. Available from: https://www.ocrelizumabinfo.global/en/homepage/additional-topics-of-interest/infections.html
   Google Scholar
• Oreja-Guevara C, Wray S, Buffels R, et al. Pregnancy outcomes in patients treated with ocrelizumab (P780). Mult Scler. 2019;25:398.
   Google Scholar
• Genentech Inc. Ocrelizumab (Ocrevus) prescribing information. 2020 [cited 2020 Jul 8]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s024lbl.pdf
   Google Scholar
• Hoffmann-La Roche Limited. Ocrelizumab (Ocrevus) product monograph. 2019 [cited 2020 Jul 8]. Available from: https://pdf.hres.ca/dpd_pm/00050590.PDF
   Google Scholar
• Mayer L, Kappos L, Racke MK, et al. Ocrelizumab infusion experience in patients with relapsing and primary progressive multiple sclerosis: results from the phase 3 randomized OPERA I, OPERA II, and ORATORIO studies. Mult Scler Relat Disord. 2019;30:236–243.
   PubMed Web of Science ®Google Scholar
• Wolinsky J, Kappos L, Montalban X, et al. Routine laboratory measures in the controlled-treatment period of phase III ocrelizumab trials in relapsing and progressive multiple sclerosis. Neurology. 2018;90:P5.425.
   Web of Science ®Google Scholar
• Derfuss T, Weber MS, Hughes R, et al. Serum immunoglobulin levels and risk of serious infections in the pivotal phase III trials of ocrelizumab in multiple sclerosis and their open-label extensions. Mult Scler. 2019;25:20–21.
   Web of Science ®Google Scholar
• Hauser SL, Kappos L, Montalban X, et al. Safety of ocrelizumab in multiple sclerosis: updated analysis in patients with relapsing and primary progressive multiple sclerosis (P648). Mult Scler. 2019;25:317–318.
   Google Scholar
• Bermel R, Waubant E, Pardo G, et al. Evaluation of shorter infusion times for ocrelizumab treatment in an extension substudy of the phase IIIb CHORDS trial (P1408). Mult Scler. 2019;25:779–780.
   Web of Science ®Google Scholar
• Miller P, Tran V, Jarrar R, et al. Safety and efficacy of ocrelizumab in patients who transitioned directly from alemtuzumab therapy. Neurology. 2020;94:4136.
   Web of Science ®Google Scholar
• Smoot K, Lucas L, Stuchiner T, et al. The impact of ocrelizumab on immunoglobulin levels and the risk of infection (P1010). Mult Scler. 2019;25:534.
   Web of Science ®Google Scholar
• Medical Dictionary for Regulatory Activities (MedDRA). Introductory guide MedDRA Version 21.0. 2018 [cited 2020 Apr 3]. Available from: https://www.meddra.org/sites/default/files/guidance/file/intguide_21_0_english.pdf
   Google Scholar
• Dirks P, Zingler V, Leemhuis J, et al. Design of a non-interventional post-marketing study to assess the long-term safety and effectiveness of ocrelizumab in German real world multiple sclerosis cohorts - the CONFIDENCE study protocol. BMC Neurol. 2020;20:95–95.
   PubMed Web of Science ®Google Scholar
• Wormser D, Evershed J, Ferreira G, et al. VERISMO: a post-marketing safety study to determine the incidence of all malignancies and breast cancer in patients with multiple sclerosis treated with ocrelizumab. Neurology. 2019;92:P4.2–043.
   Web of Science ®Google Scholar
• Wormser D, Butzkueven H, Hillert J, et al. MANUSCRIPT: long-term surveillance of ocrelizumab-treated patients with multiple sclerosis (EPO3217). Eur J Neurol. 2019;26:871.
   Web of Science ®Google Scholar
• Durali D, de Goër de Herve M-G, Gasnault J, et al. B cells and progressive multifocal leukoencephalopathy: search for the missing link. Front Immunol. 2015;6:241.
   PubMed Web of Science ®Google Scholar
• Epstein DJ, Dunn J, Deresinski S. Infectious complications of multiple sclerosis therapies: implications for screening, prophylaxis, and management. Open Forum Infect Dis. 2018;5:1–8.
   Web of Science ®Google Scholar
• Killestein J, Bermel R, Brochet B, et al. ENSEMBLE baseline results and ENSEMBLE PLUS study design: an investigation of shorter ocrelizumab infusion time in patients with relapsing-remitting multiple sclerosis. Eur J Neurol. 2019;26:664.
   Web of Science ®Google Scholar
• Rauer S, Stork L, Urbach H, et al. Drug reaction with eosinophilia and systemic symptoms after daclizumab therapy. Neurology. 2018;91:e359–e63.
   PubMed Web of Science ®Google Scholar
• Choudhary S, McLeod M, Torchia D, et al. Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome. J Clin Aesthet Dermatol. 2013;6:31–37.
   PubMedGoogle Scholar
• Luo J, Eldredge C, Cho CC, et al. Population analysis of adverse events in different age groups using big clinical trials data. JMIR Med Inform. 2016;4:e30.
   PubMed Web of Science ®Google Scholar
• Bourgeois FT, Shannon MW, Valim C, et al. Adverse drug events in the outpatient setting: an 11-year national analysis. Pharmacoepidemiol Drug Saf. 2010;19:901–910.
   PubMed Web of Science ®Google Scholar
• Davies EA, O’Mahony MS. Adverse drug reactions in special populations – the elderly. Br J Clin Pharmacol. 2015;80:796–807.
   PubMed Web of Science ®Google Scholar
• Scherer RW, Saldanha IJ. How should systematic reviewers handle conference abstracts? A view from the trenches. Syst Rev. 2019;8:264.
   PubMed Web of Science ®Google Scholar
• Zorzela L, Golder S, Liu Y, et al. Quality of reporting in systematic reviews of adverse events: systematic review. BMJ. 2014;348:f7668.
   PubMed Web of Science ®Google Scholar
• Auricchio F, Scavone C, Cimmaruta D, et al. Drugs approved for the treatment of multiple sclerosis: review of their safety profile. Expert Opin Drug Saf. 2017;16:1359–1371.
   PubMed Web of Science ®Google Scholar
• Wingerchuk DM, Carter JL. Multiple sclerosis: current and emerging disease-modifying therapies and treatment strategies. Mayo Clin Proc. 2014;89:225–240.
   PubMed Web of Science ®Google Scholar
• Lebrun C, Rocher F. Cancer risk in patients with multiple sclerosis: potential impact of disease-modifying drugs. CNS Drugs. 2018;32:939–949.
   PubMed Web of Science ®Google Scholar
• Tramacere I, Del Giovane C, Salanti G, et al. Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis. Cochrane Database Syst Rev. 2015. DOI:10.1002/14651858.CD011381.pub2.
   PubMed Web of Science ®Google Scholar