BACKGROUND: MSB11022 is a proposed adalimumab biosimilar. OBJECTIVES: To compare the efficacy, safety and immunogenicity of MSB11022 with reference adalimumab. METHODS: AURIEL-PsO was a double-blind randomized controlled equivalence trial, in which patients with moderate-to-severe chronic plaque-type psoriasis were randomized 1 : 1 to MSB11022 or reference adalimumab. The primary end point was ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 16, with a prespecified equivalence interval of ± 18%. Patients with a ≥50% improvement in PASI at week 16 were eligible to enter a double-blind extension period: patients receiving MSB11022 continued treatment, and patients receiving reference adalimumab were rerandomized 1 : 1 either to continue reference adalimumab or to switch to MSB11022. Other efficacy end points and safety, immunogenicity and pharmacokinetic parameters were evaluated at scheduled visits up to weeks 52 (efficacy and immunogenicity), 54 and 66 (safety). RESULTS: In total, 443 patients were randomized. The difference in PASI 75 response rates at week 16 between the treatment arms was -1·9%, and the 95% confidence interval (-7·8% to 4·1%) was within the prespecified equivalence interval. No notable difference in the incidence of treatment-emergent adverse events was observed between treatment arms up to the end of the trial, and no new safety signals were observed. Following treatment switch at week 16, no clinically meaningful differences in safety or immunogenicity were seen between treatment arms through to the end of the observation period. CONCLUSIONS: Therapeutic equivalence between MSB11022 and reference adalimumab was demonstrated. AURIEL-PsO provides evidence to support the similarity of both products with regard to efficacy, safety and immunogenicity. What's already known about this topic? Adalimumab is a fully human antitumour necrosis factor-α monoclonal antibody, indicated for the treatment of multiple inflammatory disorders, including psoriasis, psoriatic arthritis, rheumatoid arthritis, inflammatory bowel diseases and ankylosing spondylitis. MSB11022 is a proposed adalimumab biosimilar that has shown structural and functional similarity to the reference product in an extensive analytical comparability exercise. MSB11022 has demonstrated bioequivalence and comparable safety and immunogenicity profiles in a phase I study in healthy volunteers. What does this study add? This phase III study confirmed equivalent efficacy for MSB11022 and reference adalimumab in patients without any immunomodulation comedication in moderate-to-severe chronic plaque-type psoriasis at week 16. The efficacy, safety and immunogenicity of MSB11022 and reference adalimumab were similar over the respective observation periods (week 52 for efficacy and immunogenicity, week 66 for safety). A switch from reference adalimumab to MSB11022 at week 16 did not impact efficacy, safety or immunogenicity.

Cytel Geneva Switzerland

Dermatology Department 2nd Medical Faculty Charles University and Na Bulovce Hospital Prague Czech Republic

Fresenius Kabi Eysin Switzerland

K Papp Clinical Research and Probity Medical Research Inc Waterloo ON Canada

NIHR Clinical Research Facility University of Southampton Southampton U K

Br J Dermatol. 2020 Feb;182(2):266. doi: 10.1111/bjd.18717. PubMed

See more in PubMed

Feldmann M, Maini RN. Anti‐TNF therapy, from rationale to standard of care: what lessons has it taught us? J Immunol 2010; 185:791–4. PubMed

Kaymakcalan Z, Sakorafas P, Bose S PubMed

Lapadula G, Marchesoni A, Armuzzi A PubMed

Putrik P, Ramiro S, Kvien TK PubMed

Kalo Z, Voko Z, Ostor A PubMed PMC

Carrascosa JM, Jacobs I, Petersel D PubMed PMC

Blauvelt A, Cohen AD, Puig L PubMed

Blauvelt A, Puig L, Chimenti S PubMed

Cohen AD, Wu JJ, Puig L PubMed

Cohen HP, Blauvelt A, Rifkin RM PubMed PMC

European Medicines Agency . Guideline on similar biological medicinal products containing biotechnology‐derived proteins as active substance: non‐clinical and clinical issues. Available at: https://www.ema.europa.eu/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf (last accessed 18 July 2019).

Magnenat L, Palmese A, Fremaux C PubMed PMC

Hyland E, Mant T, Vlachos P PubMed PMC

Menter A, Tyring SK, Gordon K PubMed

Saurat JH, Stingl G, Dubertret L PubMed

Fredriksson T, Pettersson U. Severe psoriasis – oral therapy with a new retinoid. Dermatologica 1978; 157:238–44. PubMed

Schmitt J, Wozel G. The Psoriasis Area and Severity Index is the adequate criterion to define severity in chronic plaque‐type psoriasis. Dermatology 2005; 210:194–9. PubMed

Langley RG, Feldman SR, Nyirady J PubMed

Piaggio G, Elbourne DR, Pocock SJ PubMed

Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) – a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19:210–16. PubMed

Yfantopoulos J, Chantzaras A, Kontodimas S. Assessment of the psychometric properties of the EQ‐5D‐3L and EQ‐5D‐5L instruments in psoriasis. Arch Dermatol Res 2017; 309:357–70. PubMed

Bruce B, Fries JF. The Health Assessment Questionnaire (HAQ). Clin Exp Rheumatol 2005; 23 (5 Suppl. 39):S14–18. PubMed

Cauli A, Gladman DD, Mathieu A PubMed

Mrowietz U, Kragballe K, Reich K PubMed

Van Lumig PP, Lecluse LL, Driessen RJ PubMed

Woolf RT, Smith CH, Robertson K PubMed

Bissonnette R, Bolduc C, Poulin Y PubMed

Pitarch G, Sanchez‐Carazo JL, Mahiques L PubMed

Ryan C, Kirby B, Collins P PubMed

Menter A, Gordon KB, Leonardi CL PubMed

Prussick R, Unnebrink K, Valdecantos WC. Efficacy of adalimumab compared with methotrexate or placebo stratified by baseline BMI in a randomized placebo‐controlled trial in patients with psoriasis. J Drugs Dermatol 2015; 14:864–8. PubMed

Thaçi D, Ortonne JP, Chimenti S PubMed

Wu JJ. Contemporary management of moderate to severe plaque psoriasis. Am J Manag Care 2017; 23 (21 Suppl.):S403–16. PubMed

Asahina A, Nakagawa H, Etoh T PubMed

Cai L, Gu J, Zheng J PubMed PMC

Papp K, Bachelez H, Costanzo A PubMed

Lafuente‐Urrez RF, Perez‐Pelegay J. Impact of obesity on the effectiveness of adalimumab for the treatment of psoriasis: a retrospective study of 30 patients in daily practice. Eur J Dermatol 2014; 24:217–23. PubMed

Gordon KB, Duffin KC, Bissonnette R PubMed

Gordon KB, Langley RG, Leonardi C PubMed

AbbVie Inc . Prescribing information: HUMIRA (adalimumab) injection, for subcutaneous use. Available at: http://www.rxabbvie.com/pdf/humira.pdf (last accessed 18 July 2019).

Song S, Yang L, Trepicchio WL PubMed PMC

Gorovits B, Baltrukonis DJ, Bhattacharya I PubMed PMC

Menting SP, Coussens E, Pouw MF PubMed

Blauvelt A, Lacour JP, Fowler JF Jr PubMed

Jorgensen KK, Olsen IC, Goll GL PubMed

Weinblatt ME, Baranauskaite A, Dokoupilova E PubMed PMC

Yoo DH, Prodanovic N, Jaworski J PubMed PMC