Real World SB4 (Etanercept Biosimilar) Use in Patients With Psoriasis: Data from the British Association of Dermatologists Biologic Interventions Register (BADBIR)

March 2020 | Volume 19 | Issue 3 | Case Reports | 316 | Copyright © March 2020


Published online February 5, 2020

Alexander Egeberg , Giampiero Girolomoni , Steven R. Feldman , Marc-Alexander Radtke , José Manuel Carrascosa , Jeehoon Ghil , Jung Won Keum , Jieun Lee , Hyoryeong Seo

aDepartment of Dermatology and Allergy, Herlev and Gentofte Hospital, Copenhagen, Denmark bSection of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy cDepartment of Dermatology, Wake Forest University School of Medicine, NC dDermatologikum Hamburg dermatologic practice, Hamburg, Germany eHospital Universitari Germans Trias i Pujol, Universidad Autónoma de Barcelona, Barcelona, Spain fSamsung Bioepis Co., Ltd., Incheon, Republic of Korea

tinuation rate for reference etanercept at 1 year at BADBIR was reported to be 30%. The slight difference in discontinuation rate might come from the fact that in our study biologic experienced patients and patients with lower baseline PASI were included. Other studies also suggest no significant differences in risk of discontinuation between SB4 and reference etanercept, not only in psoriasis but also in RA.6,7,14

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.

DISCLOSURES

A.E. has received research funding from Pfizer, Eli Lilly, the Danish National Psoriasis Foundation, and the Kgl Hofbundtmager Aage Bang Foundation, and honoraria as consultant and/or speaker from AbbVie, Almirall, Leo Pharma, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly and Company, Novartis, Galderma, Dermavant, Bristol-Myers Squibb, and Janssen Pharmaceuticals. G.G. has been the principal investigator in clinical trials sponsored by and/or and has received personal fees from AbbVie, Abiogen, Almirall, Amgen, Bayer, Biogen, Celgene, Eli Lilly, Galderma, Hospira, Janssen, LEO Pharma, Merck, MSD, Mundipharma, Novartis, Pfizer, Pierre Fabre, Regeneron, Samsung Bioepis, Sandoz, Sanofi and Sun Pharma. S.R.F. has received research, speaking, and/or consulting support from Almirall, Leo Pharma, Boehringer Ingelheim, Mylan, Celgene, Pfizer, Ortho Dermatology, AbbVie, Samsung Bioepis, Janssen, Lilly, Merck, Novartis, and Sun Pharma. M.A.R. has served as a consultant and/or paid speaker for and/or has received research grants and/or honoraria for consulting and/or scientific lectures for and/or got travel expenses reimbursed and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Abbott/AbbVie, Almirall, Amgen, Astellas, Biogen, Biologix, Boehringer Ingelheim, Celgene, Galderma, Hexal, Janssen-Cilag, La Roche Posay, Leo, Lilly Pharma, Medac, Merck, MSD, Mundipharma, Novartis, Pfizer, Sandoz, Sanofi and Takeda Pharmaceutical. J.M.C. has nothing to disclose. J.G., J.W.K., J.L. and H.S. are full-time employees of Samsung Bioepis. The study was sponsored by Samsung Bioepis and Samsung Bioepis received raw data from BADBIR and performed analyses.

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AUTHOR CORRESPONDENCE

Alexander Egeberg MD PhD alexander.egeberg@gmail.com