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Comparative efficacy and safety of adalimumab biosimilars and adalimumab in patients with rheumatoid arthritis presenting an insufficient response to methotrexate: a network meta-analysis

Vergleichbare Wirksamkeit und Sicherheit von Adalimumab-Biosimilars und Adalimumab bei Patienten mit rheumatoider Arthritis und unzureichendem Ansprechen auf Methotrexat: eine Netzwerk-Metaanalyse

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Abstract

Objective

We assessed the relative efficacy and safety of adalimumab and biosimilars in patients with active rheumatoid arthritis (RA) presenting an inadequate response to methotrexate (MTX).

Methods

We performed a Bayesian network meta-analysis combining direct and indirect evidence from randomized controlled trials (RCTs) examining efficacy and safety of adalimumab biosimilars versus adalimumab in patients with active RA despite MTX therapy.

Results

Overall, 8 RCTs involving 3577 patients, including 8 biologic types, met the inclusion criteria. MSB11022 is listed at the top left of the diagonal of the league table, as it was associated with the most favorable surface under the cumulative ranking curve (SUCRA) for the American College of Rheumatology 20 (ACR20) response rate; FKB327 is listed at the bottom right of the diagonal of the league table, as it was associated with the least favorable results. Based on SUCRA, MSB11022 presented the highest probability of being the best treatment for achieving the ACR20 response rate (SUCRA = 0.623), followed by PF-06410293, CinnoRA, BI 695501, ABP 50, Exemptia, SB5, adalimumab, and FKB327 (SUCRA = 0.390); no difference was observed in ACR20 response rates between biosimilars and adalimumab. Although statistically non-significant, differences in safety ranking were observed for serious adverse events (SAEs) among the interventions, with MSB11022 presenting the highest probability of being safe (SUCRA = 0.865) and Exemptia the lowest (SUCRA = 0.300).

Conclusion

No significant difference was detected between adalimumab biosimilars and the originator in terms of ACR20 response rates and SAEs in the studied patients.

Zusammenfassung

Ziel

Untersucht wurde die relative Wirksamkeit und Sicherheit von Adalimumab und entsprechenden Biosimilars bei Patienten mit aktiver rheumatoider Arthritis (RA), bei denen das Ansprechen auf Methotrexat (MTX) unzureichend war.

Methoden

Dazu führten die Autoren eine Bayes-Netzwerk-Metaanalyse durch, bei der die direkte und die indirekte Evidenz aus randomisierten kontrollierten Studien (RCT) zur Wirksamkeit und Sicherheit von Adalimumab-Biosimilars vs. Adalimumab bei Patienten mit aktiver RA trotz MTX-Therapie kombiniert wurden.

Ergebnisse

Insgesamt erfüllten 8 RCT mit 3577 Patienten, in denen 8 Typen von Biologika untersucht wurden, die Einschlusskriterien. MSB11022 ist links oben auf der Diagonale der Rangliste aufgeführt, da es mit der günstigsten SUCRA („surface under the cumulative ranking curve“) für die Responserate mit 20 % Verbesserung gemäß American College of Rheumatology (ACR20) einherging; FKB327 ist rechts unten auf der Diagonale der Rangliste aufgeführt, da es mit den ungünstigsten Ergebnissen einherging. Auf Grundlage der SUCRA besteht für MSB11022 die höchste Wahrscheinlichkeit, die beste Behandlung zur Erzielung der ACR20-Responserate zu sein (SUCRA = 0,623), es folgten PF-06410293, CinnoRA, BI 695501, ABP 50, Exemptia, SB5, Adalimumab und FKB327 (SUCRA = 0,390); zwischen Biosimilars und Adalimumab wurde kein Unterschied in Bezug auf die ACR20-Responserate festgestellt. Zwar waren sie statistisch nicht signifikant, doch wurden Unterschiede in der Rangliste der Sicherheit für schwere unerwünschte Ereignisse (SAE) zwischen den Interventionen beobachtet, dabei bestand für MSB11022 höchste Wahrscheinlichkeit, sicher zu sein (SUCRA = 0,865), und für Exemptia die diesbezüglich geringste Wahrscheinlichkeit (SUCRA = 0,300).

Schlussfolgerung

Zwischen Adalimumab-Biosimilars und der Originalsubstanz wurde kein signifikanter Unterschied hinsichtlich der ACR20-Responserate und SAE bei den untersuchten Patienten festgestellt.

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Authors and Affiliations

  1. Division of Rheumatology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, 73, Goryeodae-ro, Seongbuk-gu, 02841, Seoul, Korea (Republic of)

    Young Ho Lee MD, PhD

  2. Division of Rheumatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea (Republic of)

    Gwan Gyu Song

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  1. Young Ho Lee MD, PhD
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Correspondence to Young Ho Lee MD, PhD.

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Conflict of interest

Y.H. Lee and G.G. Song declare that they have no competing interests.

For this article no studies with human participants or animals were performed by any of the authors. All studies performed were in accordance with the ethical standards indicated in each case.

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U. Müller-Ladner, Bad Nauheim

U. Lange, Bad Nauheim

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Lee, Y.H., Song, G.G. Comparative efficacy and safety of adalimumab biosimilars and adalimumab in patients with rheumatoid arthritis presenting an insufficient response to methotrexate: a network meta-analysis. Z Rheumatol 82, 64–70 (2023). https://doi.org/10.1007/s00393-021-01013-3

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  • DOI: https://doi.org/10.1007/s00393-021-01013-3

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