The 5 patients who stopped SB4 for patient choice or non-compliance may reflect nocebo effects associated with biosimilars. Nocebo effects, patients’ negative anticipation of biosimilar treatment, are often observed in real world settings and result in suboptimal outcomes.10 Such nocebo effect can be managed by obtaining informed consent prior to switching to biosimilars and by educating both HCP and patients to increase awareness on biosimilars.11 Real world evidence on biosimilars can provide additional reassurance to reduce nocebo effect.12
Analysis on reduction in PASI and DLQI at 6 month from the patients with available data showed SB4 either maintained or improved disease activity. This is in line with other studies where similar levels of PASI reduction are observed with SB4 treatment.7,15
While a limitation of this study is that we did not have access to raw data on other biologics in the register for comparison, we were able to compare our findings to previously published BADBIR data on etanercept.
In conclusion, data from BADBIR show that the use of SB4 in clinical practice was effective in patients with psoriasis. As more long-term real world evidence on biosimilars accumulates, confidence in biosimilars will likely be increased, and nocebo effect with biosimilar use may be reduced, thereby helping to realize more fully the cost saving potiential of biosimilars.
2. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues https://www.ema.europa.eu/en/documents/ scientific-guideline/guideline-similar-biological-medicinal-products-containing- biotechnology-derived-proteins-active_en-2.pdf Accessed Oct 31, 2019.
3. Kim S, Song J, Park S, et al. Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar. MAbs. 2017;9(4):704-714.
4. Carrascosa J-M, Jacobs I, Petersel D, Strohal R. Biosimilar drugs for psoriasis: principles, present, and near future. Dermatol Ther (Heidelb). 2018;8(2):173-194.
5. European Medicines Agency. Benepali summary of product characteristics. https://www.ema.europa.eu/en/documents/variation-report/benepali-h-c- 4007-x-0016-epar-assessment-report_en.pdf Accessed Oct 31, 2019.
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8. Burden AD, Warren RB, Kleyn CE, et al. The British Association of Dermatologists' Biologic Interventions Register (BADBIR): design, methodology and objectives. Br J Dermatol. 2012;166(3):545-554.
9. Medicine optimisation dashboard. NHS Trusts https://apps.nhsbsa.nhs.uk/ MOD/AtlasTrustsMedsOp/atlas.html Assessed Sep 18, 2019 10. Rezk MF, Pieper B. Treatment outcomes with biosimilars: be aware of the nocebo effect. Rheumatol Ther. 2017;4(2):209-218.
11. Kristensen LE, Alten R, Puig L, et al. Non-pharmacological effects in switching medication: the nocebo effect in switching from originator to biosimilar agent. BioDrugs. 2018;32(5):397-404.
12. Ebbers HC, Pieper B, Issa A, Addison J, Freudensprung U, Rezk MF. Realworld evidence on etanercept biosimilar sb4 in etanercept-naïve or switching patients: a systematic review. Rheumatol Ther. 2019;6(3):317-338.
13. Warren RB, Smith CH, Yiu ZZN, et al. Differential drug survival of biologic therapies for the treatment of psoriasis: a prospective observational cohort study from the British Association of Dermatologists Biologic Interventions Register (BADBIR). J Invest Dermatol. 2015;135(11):2632-2640.
14. Glintborg B, Loft AG, Omerovic E, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis. 2019;78(2):192-200.
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