Skip to main content
Top
Published in: Clinical Rheumatology 1/2021

01-01-2021 | Adalimumab | Original Article

Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases

Authors: Cosimo Bruni, Roberta Bitti, Francesca Nacci, Laura Cometi, Lorenzo Tofani, Francesca Bartoli, Ginevra Fiori, Marco Matucci-Cerinic

Published in: Clinical Rheumatology | Issue 1/2021

Login to get access

Abstract

Objective

SB5 showed comparable efficacy and safety profile in respect to adalimumab originator (ADA) in randomized clinical trials of rheumatoid arthritis (RA) and psoriasis. We aimed to describe the efficacy and safety of SB5 after switching from ADA in RA, axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) and juvenile idiopathic arthritis (JIA) patients.

Method

Adult RA, PsA, axSpA, JIA patients treated with ADA for at least 6 months, switched to SB5 in stable clinical conditions, were eligible. Data on safety, activity indexes and patient-reported outcomes were collected at baseline, 3 and 6 months after switching.

Results

Eighty-two patients (19 RA, 28 PsA, 32 axSpA and 3 JIA; 45 females, mean age 54 ± 14 years, disease duration 13 ± 7 years, ADA duration 6 ± 3 years) were enrolled. RA patients showed stable conditions, while PsA patients showed an increase in both HAQ, DAS28(CRP) and DAPSA and axSpA patients an increase in VAS pain, VAS patient disease activity and ASDAS, both at 3 months. There were changes in the concomitant medications profile, with regression of activity indexes increases at 6 months. Adverse events were reported by 33.7% patients at 3 months and 16.6% patients at 6 months, mostly disease flares and infectious events. Two patients stopped SB5.

Conclusions

Despite temporary changes in the concomitant medication profile for mild disease flares, our real-life data replicate the safety profile of switching from ADA to SB5 in RA, with additional data for its applicability in PsA and axSpA patients, further supporting switching to biosimilars in treating inflammatory rheumatic conditions.
Key Points
• Switching from adalimumab originator to SB5 is feasible in real life rheumatic inflammatory joint diseases.
• Mild disease flares can present after switching from originator adalimumab to SB5, in particular in axial spondyloarthritis and psoriatic arthritis.
• Changes in concomitant medications profile allows the control of minor disease flares presenting after switching from adalimumab originator to SB5.
Appendix
Available only for authorised users
Literature
6.
go back to reference Smolen JS, Landewé R, Bijlsma J, Burmester G, Chatzidionysiou K, Dougados M, Nam J, Ramiro S, Voshaar M, van Vollenhoven R, Aletaha D, Aringer M, Boers M, Buckley CD, Buttgereit F, Bykerk V, Cardiel M, Combe B, Cutolo M, van Eijk-Hustings Y, Emery P, Finckh A, Gabay C, Gomez-Reino J, Gossec L, Gottenberg JE, Hazes JMW, Huizinga T, Jani M, Karateev D, Kouloumas M, Kvien T, Li Z, Mariette X, McInnes I, Mysler E, Nash P, Pavelka K, Poór G, Richez C, van Riel P, Rubbert-Roth A, Saag K, da Silva J, Stamm T, Takeuchi T, Westhovens R, de Wit M, van der Heijde D (2016) EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 76(6):960–977. https://doi.org/10.1136/annrheumdis-2016-210715CrossRef Smolen JS, Landewé R, Bijlsma J, Burmester G, Chatzidionysiou K, Dougados M, Nam J, Ramiro S, Voshaar M, van Vollenhoven R, Aletaha D, Aringer M, Boers M, Buckley CD, Buttgereit F, Bykerk V, Cardiel M, Combe B, Cutolo M, van Eijk-Hustings Y, Emery P, Finckh A, Gabay C, Gomez-Reino J, Gossec L, Gottenberg JE, Hazes JMW, Huizinga T, Jani M, Karateev D, Kouloumas M, Kvien T, Li Z, Mariette X, McInnes I, Mysler E, Nash P, Pavelka K, Poór G, Richez C, van Riel P, Rubbert-Roth A, Saag K, da Silva J, Stamm T, Takeuchi T, Westhovens R, de Wit M, van der Heijde D (2016) EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 76(6):960–977. https://​doi.​org/​10.​1136/​annrheumdis-2016-210715CrossRef
8.
go back to reference Kerschbaumer A, Sepriano A, Smolen JS, van der Heijde D, Dougados M, van Vollenhoven R, McInnes IB, Bijlsma JWJ, Burmester GR, de Wit M, Falzon L, Landewé R (2019) Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis https://doi.org/10.1136/annrheumdis-2019-216656, annrheumdis-2019-216656 Kerschbaumer A, Sepriano A, Smolen JS, van der Heijde D, Dougados M, van Vollenhoven R, McInnes IB, Bijlsma JWJ, Burmester GR, de Wit M, Falzon L, Landewé R (2019) Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis https://​doi.​org/​10.​1136/​annrheumdis-2019-216656, annrheumdis-2019-216656
9.
go back to reference Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, Emery P, Landewé R, Oliver S, Aletaha D, Betteridge N, Braun J, Burmester G, Cañete JD, Damjanov N, FitzGerald O, Haglund E, Helliwell P, Kvien TK, Lories R, Luger T, Maccarone M, Marzo-Ortega H, McGonagle D, McInnes IB, Olivieri I, Pavelka K, Schett G, Sieper J, van den Bosch F, Veale DJ, Wollenhaupt J, Zink A, van der Heijde D (2016) European league against rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis 75(3):499–510. https://doi.org/10.1136/annrheumdis-2015-208337CrossRefPubMed Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, Emery P, Landewé R, Oliver S, Aletaha D, Betteridge N, Braun J, Burmester G, Cañete JD, Damjanov N, FitzGerald O, Haglund E, Helliwell P, Kvien TK, Lories R, Luger T, Maccarone M, Marzo-Ortega H, McGonagle D, McInnes IB, Olivieri I, Pavelka K, Schett G, Sieper J, van den Bosch F, Veale DJ, Wollenhaupt J, Zink A, van der Heijde D (2016) European league against rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis 75(3):499–510. https://​doi.​org/​10.​1136/​annrheumdis-2015-208337CrossRefPubMed
10.
go back to reference Ringold S, Weiss PF, Beukelman T, DeWitt E, Ilowite NT, Kimura Y, Laxer RM, Lovell DJ, Nigrovic PA, Robinson AB, Vehe RK, American Collge of Rheumatology (2013) 2013 update of the 2011 American College of Rheumatology Recommendations for the treatment of juvenile idiopathic arthritis. Arthritis Rheum 65(10):2499–2512. https://doi.org/10.1002/art.38092CrossRefPubMedPubMedCentral Ringold S, Weiss PF, Beukelman T, DeWitt E, Ilowite NT, Kimura Y, Laxer RM, Lovell DJ, Nigrovic PA, Robinson AB, Vehe RK, American Collge of Rheumatology (2013) 2013 update of the 2011 American College of Rheumatology Recommendations for the treatment of juvenile idiopathic arthritis. Arthritis Rheum 65(10):2499–2512. https://​doi.​org/​10.​1002/​art.​38092CrossRefPubMedPubMedCentral
11.
go back to reference van der Heijde D, Ramiro S, Landewé R, Baraliakos X, van den Bosch F, Sepriano A, Regel A, Ciurea A, Dagfinrud H, Dougados M, van Gaalen F, Géher P, van der Horst-Bruinsma I, Inman RD, Jongkees M, Kiltz U, Kvien TK, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compàn V, Ozgocmen S, Pimentel-Santos FM, Reveille J, Rudwaleit M, Sieper J, Sampaio-Barros P, Wiek D, Braun J (2017) 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis 76(6):978–991. https://doi.org/10.1136/annrheumdis-2016-210770CrossRefPubMed van der Heijde D, Ramiro S, Landewé R, Baraliakos X, van den Bosch F, Sepriano A, Regel A, Ciurea A, Dagfinrud H, Dougados M, van Gaalen F, Géher P, van der Horst-Bruinsma I, Inman RD, Jongkees M, Kiltz U, Kvien TK, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compàn V, Ozgocmen S, Pimentel-Santos FM, Reveille J, Rudwaleit M, Sieper J, Sampaio-Barros P, Wiek D, Braun J (2017) 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis 76(6):978–991. https://​doi.​org/​10.​1136/​annrheumdis-2016-210770CrossRefPubMed
12.
go back to reference Maksymowych WP, Gladman D, Rahman P, Boonen A, Bykerk V, Choquette D, Dimond S, Fortin P, Karsh J, Klinkhoff AV, Mosher D, Mulholland K, Olszynski WP, Russell AS, Savage L, Shanner L, Shojania K, Starr M, Thomson G, Zummer M, Inman R, Canadian Rheumatology Association/ Spondyloarthritis Research Consortium of Canada (2007) The Canadian rheumatology association/ Spondyloarthritis research consortium of Canada treatment recommendations for the management of spondyloarthritis: a national multidisciplinary stakeholder project. J Rheumatol 34(11):2273–2284PubMed Maksymowych WP, Gladman D, Rahman P, Boonen A, Bykerk V, Choquette D, Dimond S, Fortin P, Karsh J, Klinkhoff AV, Mosher D, Mulholland K, Olszynski WP, Russell AS, Savage L, Shanner L, Shojania K, Starr M, Thomson G, Zummer M, Inman R, Canadian Rheumatology Association/ Spondyloarthritis Research Consortium of Canada (2007) The Canadian rheumatology association/ Spondyloarthritis research consortium of Canada treatment recommendations for the management of spondyloarthritis: a national multidisciplinary stakeholder project. J Rheumatol 34(11):2273–2284PubMed
13.
go back to reference Ward MM, Deodhar A, Akl EA, Lui A, Ermann J, Gensler LS, Smith JA, Borenstein D, Hiratzka J, Weiss PF, Inman RD, Majithia V, Haroon N, Maksymowych WP, Joyce J, Clark BM, Colbert RA, Figgie MP, Hallegua DS, Prete PE, Rosenbaum JT, Stebulis JA, van den Bosch F, Yu DTY, Miller AS, Reveille JD, Caplan L (2016) American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 recommendations for the treatment of Ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol Hoboken NJ 68(2):282–298. https://doi.org/10.1002/art.39298CrossRef Ward MM, Deodhar A, Akl EA, Lui A, Ermann J, Gensler LS, Smith JA, Borenstein D, Hiratzka J, Weiss PF, Inman RD, Majithia V, Haroon N, Maksymowych WP, Joyce J, Clark BM, Colbert RA, Figgie MP, Hallegua DS, Prete PE, Rosenbaum JT, Stebulis JA, van den Bosch F, Yu DTY, Miller AS, Reveille JD, Caplan L (2016) American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 recommendations for the treatment of Ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol Hoboken NJ 68(2):282–298. https://​doi.​org/​10.​1002/​art.​39298CrossRef
14.
go back to reference Ruiz S (2017) Biosimilars in the EU. Biosimilar Drug Prod Dev 395–411 Ruiz S (2017) Biosimilars in the EU. Biosimilar Drug Prod Dev 395–411
16.
go back to reference Weinblatt ME, Baranauskaite A, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, Pileckyte M, Jedrychowicz-Rosiak K, Baek I, Ghil J (2018) Switching from reference adalimumab to SB5 (adalimumab biosimilar) in patients with rheumatoid arthritis: fifty-two-week phase III randomized study results. Arthritis Rheumatol Hoboken NJ 70(6):832–840. https://doi.org/10.1002/art.40444CrossRef Weinblatt ME, Baranauskaite A, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, Pileckyte M, Jedrychowicz-Rosiak K, Baek I, Ghil J (2018) Switching from reference adalimumab to SB5 (adalimumab biosimilar) in patients with rheumatoid arthritis: fifty-two-week phase III randomized study results. Arthritis Rheumatol Hoboken NJ 70(6):832–840. https://​doi.​org/​10.​1002/​art.​40444CrossRef
17.
go back to reference Weinblatt ME, Baranauskaite A, Niebrzydowski J, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, Pileckyte M, Jedrychowicz-Rosiak K, Cheong SY, Ghil J, Sokolovic S, Mekic M, Prodanovic N, Gajic B, Karaselimovic-Dzambasovic E, Pojskic B, Toncheva A, Dimitar P, Rodina L, Geneva-Popova M, Staykov I, Stoilov R, Podrazilova L, Mosterova Z, Simkova G, Kopackova J, Stejfova Z, Vencovsky J, Urbanova Z, Janska L, Galatíkova D, Stropuviene S, Sniuoliene I, Sitek-Ziolkowska K, Rell-Bakalarska M, Kolasa R, Daniluk S, Sliwowska B, Bartosik-Twardowska M, Brzezicki J, Konieczny M, Jeka S, Choe J, Bae S, Kang Y, Prystupa L, Vyacheslav Z, Gasanov I, Yatsyshyn R, Rekalov D, Iaremenko O, Stanislavchuk M, Tseluyko V (2018) Phase III randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis. Arthritis Rheumatol Hoboken NJ 70(1):40–48. https://doi.org/10.1002/art.40336CrossRef Weinblatt ME, Baranauskaite A, Niebrzydowski J, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, Pileckyte M, Jedrychowicz-Rosiak K, Cheong SY, Ghil J, Sokolovic S, Mekic M, Prodanovic N, Gajic B, Karaselimovic-Dzambasovic E, Pojskic B, Toncheva A, Dimitar P, Rodina L, Geneva-Popova M, Staykov I, Stoilov R, Podrazilova L, Mosterova Z, Simkova G, Kopackova J, Stejfova Z, Vencovsky J, Urbanova Z, Janska L, Galatíkova D, Stropuviene S, Sniuoliene I, Sitek-Ziolkowska K, Rell-Bakalarska M, Kolasa R, Daniluk S, Sliwowska B, Bartosik-Twardowska M, Brzezicki J, Konieczny M, Jeka S, Choe J, Bae S, Kang Y, Prystupa L, Vyacheslav Z, Gasanov I, Yatsyshyn R, Rekalov D, Iaremenko O, Stanislavchuk M, Tseluyko V (2018) Phase III randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis. Arthritis Rheumatol Hoboken NJ 70(1):40–48. https://​doi.​org/​10.​1002/​art.​40336CrossRef
18.
go back to reference Bae SC, Lee YH (2018) Comparative efficacy and safety of biosimilar adalimumab and originator adalimumab in combination with methotrexate in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials. Clin Rheumatol 37(5):1199–1205CrossRef Bae SC, Lee YH (2018) Comparative efficacy and safety of biosimilar adalimumab and originator adalimumab in combination with methotrexate in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials. Clin Rheumatol 37(5):1199–1205CrossRef
20.
go back to reference Wolfe F, Michaud K, Strand V (2005) Expanding the definition of clinical differences: from minimally clinically important differences to really important differences. Analyses in 8931 patients with rheumatoid arthritis. J Rheumatol 32(4):583–589PubMed Wolfe F, Michaud K, Strand V (2005) Expanding the definition of clinical differences: from minimally clinically important differences to really important differences. Analyses in 8931 patients with rheumatoid arthritis. J Rheumatol 32(4):583–589PubMed
Metadata
Title
Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases
Authors
Cosimo Bruni
Roberta Bitti
Francesca Nacci
Laura Cometi
Lorenzo Tofani
Francesca Bartoli
Ginevra Fiori
Marco Matucci-Cerinic
Publication date
01-01-2021
Publisher
Springer International Publishing
Published in
Clinical Rheumatology / Issue 1/2021
Print ISSN: 0770-3198
Electronic ISSN: 1434-9949
DOI
https://doi.org/10.1007/s10067-020-05199-w

Other articles of this Issue 1/2021

Clinical Rheumatology 1/2021 Go to the issue