Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent

. 2018 Oct ; 32 (5) : 397-404.

Jazyk angličtina Země Nový Zéland Médium print

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid30269270
Odkazy

PubMed 30269270
PubMed Central PMC6182448
DOI 10.1007/s40259-018-0306-1
PII: 10.1007/s40259-018-0306-1
Knihovny.cz E-zdroje

The nocebo effect is defined as the incitement or the worsening of symptoms induced by any negative attitude from non-pharmacological therapeutic intervention, sham, or active therapies. When a patient anticipates a negative effect associated with an intervention, medication or change in medication, they may then experience either an increase in this effect or experience it de novo. Although less is known about the nocebo effect compared with the placebo effect, widespread interest in the nocebo effect observed with statin therapy and a literature review highlighting the nocebo effect across at least ten different disease areas strongly suggests this is a common phenomenon. This effect has also recently been shown to play a role when introducing a medication or changing an established medication, for example, when switching patients from a reference biologic to a biosimilar. Given the important role biosimilars play in providing cost-effective alternatives to reference biologics, increasing physician treatment options and patient access to effective biologic treatment, it is important that we understand this phenomenon and aim to reduce this effect when possible. In this paper, we propose three key strategies to help mitigate the nocebo effect in clinical practice when switching patients from reference biologic to biosimilar: positive framing, increasing patient and healthcare professionals' understanding of biosimilars and utilising a managed switching programme.

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Orwell G. Politics and the English language. 1. London: Penguin Classics; 2013.

Häuser W, Hansen E, Enck P. Nocebo phenomena in medicine: their relevance in everyday clinical practice. Dtsch Arztebl Int. 2012;109:459–465. PubMed PMC

Planès S, Villier C, Mallaret M. The nocebo effect of drugs. Pharmacol Res Perspect. 2016;4:e00208. doi: 10.1002/prp2.208. PubMed DOI PMC

Shapiro AK, Shapiro E. The powerful placebo: from ancient priest to modern physician. 1. Baltimore: The Johns Hopkins University Press; 1998. PubMed

Levine JD, Gordon NC, Fields HL. The mechanism of placebo analgesia. Lancet. 1978;2:654–657. doi: 10.1016/S0140-6736(78)92762-9. PubMed DOI

Aslaksen PM, Åsli O, Øvervoll M, Bjørkedal E. Nocebo hyperalgesia and the startle response. Neuroscience. 2016;339:599–607. doi: 10.1016/j.neuroscience.2016.10.040. PubMed DOI

Gagne JJ, Avorn J, Shrank WH, Schneeweiss S. Refilling and switching of antiepileptic drugs and seizure-related events. Clin Pharmacol Ther. 2010;88:347–353. doi: 10.1038/clpt.2010.90. PubMed DOI PMC

Napadow V, Li A, Loggia ML, Kim J, Mawla I, Desbordes G, et al. The imagined itch: brain circuitry supporting nocebo-induced itch in atopic dermatitis patients. Allergy. 2015;70:1485–1492. doi: 10.1111/all.12727. PubMed DOI PMC

Weissenfeld J, Stock S, Lungen M, Gerber A. The nocebo effect: a reason for patients’ non-adherence to generic substitution? Pharmazie. 2010;65:451–456. PubMed

Kesselheim AS, Stedman MR, Bubrick EJ, Gagne JJ, Misono AS, Lee JL, et al. Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: a systematic review and meta-analysis. Drugs. 2010;70:605–621. doi: 10.2165/10898530-000000000-00000. PubMed DOI PMC

Mitsikostas DD, Mantonakis LI, Chalarakis NG. Nocebo is the enemy, not placebo. A meta-analysis of reported side effects after placebo treatment in headaches. Cephalalgia. 2011;31:550–561. doi: 10.1177/0333102410391485. PubMed DOI

Papadopoulos D, Mitsikostas DD. A meta-analytic approach to estimating nocebo effects in neuropathic pain trials. J Neurol. 2012;259:436–447. doi: 10.1007/s00415-011-6197-4. PubMed DOI

Okais C, Gay C, Seon F, Buchaille L, Chary E, Soubeyrand B. Disease-specific adverse events following nonlive vaccines: a paradoxical placebo effect or a nocebo phenomenon? Vaccine. 2011;29:6321–6326. doi: 10.1016/j.vaccine.2011.05.045. PubMed DOI

Liccardi G, Senna G, Russo M, Bonadonna P, Crivellaro M, Dama A, et al. Evaluation of the nocebo effect during oral challenge in patients with adverse drug reactions. J Investig Allergol Clin Immunol. 2004;14:104–107. PubMed

Vernia P, Di Camillo M, Foglietta T, Avallone VE, De Carolis A. Diagnosis of lactose intolerance and the “nocebo” effect: the role of negative expectations. Dig Liver Dis. 2010;42:616–619. doi: 10.1016/j.dld.2010.02.005. PubMed DOI

Voelker R. Nocebos contribute to host of ills. JAMA. 1996;275:345–347. doi: 10.1001/jama.1996.03530290015007. PubMed DOI

Pollo A, Torre E, Lopiano L, Rizzone M, Lanotte M, Cavanna A, et al. Expectation modulates the response to subthalamic nucleus stimulation in Parkinsonian patients. NeuroReport. 2002;13:1383–1386. doi: 10.1097/00001756-200208070-00006. PubMed DOI

Bootzin RR, Bailey ET. Understanding placebo, nocebo, and iatrogenic treatment effects. J Clin Psychol. 2005;61:871–880. doi: 10.1002/jclp.20131. PubMed DOI

Barsky AJ, Saintfort R, Rogers MP, Borus JF. Nonspecific medication side effects and the nocebo phenomenon. JAMA. 2002;287:622–627. doi: 10.1001/jama.287.5.622. PubMed DOI

Mitsikostas DD, Mantonakis L, Chalarakis N. Nocebo in clinical trials for depression: a meta-analysis. Psychiatry Res. 2014;215:82–86. doi: 10.1016/j.psychres.2013.10.019. PubMed DOI

Jørgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389:2304–2316. doi: 10.1016/S0140-6736(17)30068-5. PubMed DOI

Khan NA, Spencer HJ, Abda E, Aggarwal A, Alten R, Ancuta C, et al. Determinants of discordance in patients’ and physicians’ rating of rheumatoid arthritis disease activity. Arthritis Care Res (Hoboken). 2012;64:206–214. doi: 10.1002/acr.20685. PubMed DOI PMC

Nikiphorou E, Radner H, Chatzidionysiou K, Desthieux C, Zabalan C, van Eijk-Hustings Y, et al. Patient global assessment in measuring disease activity in rheumatoid arthritis: a review of the literature. Arthritis Res Ther. 2016;18:251. doi: 10.1186/s13075-016-1151-6. PubMed DOI PMC

Tweehuysen Lieke, Huiskes Victor J. B., van den Bemt Bart J. F, Vriezekolk Johanna E., Teerenstra Steven, van den Hoogen Frank H. J., van den Ende Cornelia H., den Broeder Alfons A. Open-Label, Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4. Arthritis & Rheumatology. 2018;70(9):1408–1418. doi: 10.1002/art.40516. PubMed DOI

Tweehuysen L, van den Bemt BJF, van Ingen IL, de Jong AJL, van der Laan WH, van den Hoogen FHJ, et al. Subjective complaints as the main reason for biosimilar discontinuation after open-label transition from reference infliximab to biosimilar infliximab. Arthritis Rheumatol. 2018;70:60–68. doi: 10.1002/art.40324. PubMed DOI

Tweehuysen L, Huiskes VJB, van den Bemt BJF, van den Hoogen FHJ, den Broeder AA. FRI0200 Higher acceptance and persistence rates after biosimilar transitioning in patients with a rheumatic disease after employing an enhanced communication strategy. Ann Rheum Dis. 2017;76:557.

Nikiphorou E, Kautiainen H, Hannonen P, Asikainen J, Kokko A, Rannio T, et al. Clinical effectiveness of CT-P13 (infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther. 2015;15:1677–1683. doi: 10.1517/14712598.2015.1103733. PubMed DOI

Glintborg B, Sørensen IJ, Jensen DV, Krogh NS, Loft AG, Espesen J, et al. A nationwide non-medical switch from originator to biosimilar infliximab in patients with inflammatory arthritis. eleven months’ clinical outcomes from the Danbio Registry. Abstract 951. Arthritis Rheumatol. 2016;68(Suppl 10). https://acrabstracts.org/abstract/clinical-and-immunogenicity-outcomes-after-switching-treatment-from-innovator-infliximab-to-biosimilar-infliximab-in-rheumatic-diseases-in-daily-clinical-practice/. Accessed 1 Jan 2018.

Tweehuysen L, van den Bemt BJF, van Ingen IL, de Jong AJL, van der Laan WH, van den Hoogen FHJ, et al. Clinical and immunogenicity outcomes after switching treatment from innovator infliximab to biosimilar infliximab in rheumatic diseases in daily clinical practice. Abstract 627. Arthritis Rheumatol. 2016;68(Suppl 10). https://acrabstracts.org/abstract/clinical-and-immunogenicity-outcomes-after-switching-treatment-from-innovator-infliximab-to-biosimilar-infliximab-in-rheumatic-diseases-in-daily-clinical-practice/. Accessed 1 Jan 2018.

Glintborg B, Sørensen IJ, Loft AG, Esbesen J, Lindegaard H, Jensen DV, et al. FRI0190 Clinical outcomes from a nationwide non-medical switch from originator to biosimilar etanercept in patients with inflammatory arthritis after 5 months follow-up. Results from the danbio registry. Ann Rheum Dis. 2017;76:553–554. doi: 10.1136/annrheumdis-2016-210742. PubMed DOI

Scherlinger Marc, Germain Vincent, Labadie Céline, Barnetche Thomas, Truchetet Marie-Elise, Bannwarth Bernard, Mehsen-Cetre Nadia, Richez Christophe, Schaeverbeke Thierry. Switching from originator infliximab to biosimilar CT-P13 in real-life: The weight of patient acceptance. Joint Bone Spine. 2018;85(5):561–567. doi: 10.1016/j.jbspin.2017.10.003. PubMed DOI

Boone NW, Liu L, Romberg-Camps MJ, Duijsens L, Houwen C, van der Kuy PHM, et al. The nocebo effect challenges the non-medical infliximab switch in practice. Eur J Clin Pharmacol. 2018;74:655–661. doi: 10.1007/s00228-018-2418-4. PubMed DOI PMC

Rodriguez-Raecke R, Doganci B, Breimhorst M, Stankewitz A, Buchel C, Birklein F, et al. Insular cortex activity is associated with effects of negative expectation on nociceptive long-term habituation. J Neurosci. 2010;30:11363–11368. doi: 10.1523/JNEUROSCI.2197-10.2010. PubMed DOI PMC

Smolen JS, Landewé R, Bijlsma J, Burmester G, Chatzidionysiou K, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76:960–977. doi: 10.1136/annrheumdis-2016-210715. PubMed DOI

Jacobs I, Singh E, Sewell KL, Al-Sabbagh A, Shane LG. Patient attitudes and understanding about biosimilars: an international cross-sectional survey. Patient Prefer Adherence. 2016;10:937–948. doi: 10.2147/PPA.S104891. PubMed DOI PMC

Cohen H, Beydoun D, Chien D, Lessor T, McCabe D, Muenzberg M, et al. Awareness, knowledge, and perceptions of biosimilars among specialty physicians. Adv Ther. 2017;33:2160–2172. doi: 10.1007/s12325-016-0431-5. PubMed DOI PMC

Akl EA, Oxman AD, Herrin J, Vist GE, Terrenato I, Sperati F, et al. Framing of health information messages. Cochrane Database Syst Rev. 2011:CD006777. 10.1002/14651858.CD006777.pub2. PubMed

Varelmann D, Pancaro C, Cappiello EC, Camann WR. Nocebo-induced hyperalgesia during local anesthetic injection. Anesth Analg. 2010;110:868–870. doi: 10.1213/ANE.0b013e3181cc5727. PubMed DOI

Colloca L, Finniss D. Nocebo effects, patient-clinician communication, and therapeutic outcomes. JAMA. 2012;307:567–568. doi: 10.1001/jama.2012.115. PubMed DOI PMC

Edwards C, editor. Switching patients from originator to biosimilar medications in rheumatoid arthritis: limiting the ‘nocebo’ effect. Madrid: EULAR. 2017.

Federatie Medisch Specialisten, NVZA. NVZA Toolbox Biosimilars: Een praktische handleiding voor succesvolle implementatie van biosimilars in de medisch specialistische zorg. 2017. http://nvza.nl/wp-content/uploads/2017/04/NVZA-Toolbox-biosimilars_7-april-2017.pdf. Accessed Mar 2018.

Rezk MF, Pieper B. Treatment outcomes with biosimilars: be aware of the nocebo effect. Rheumatol Ther. 2017;4:209–218. doi: 10.1007/s40744-017-0085-z. PubMed DOI PMC

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