Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis: Fifty-Two–Week Phase III Randomized Study Results

Arthritis and Rheumatology

Volumn 70, Issue 6, 2018, Pages 832-840

  Weinblatt, Michael E ^a   Baranauskaite, Asta ^b   Dokoupilova, Eva ^c   Zielinska, Agnieszka ^d   Jaworski, Janusz ^e   Racewicz, Artur ^f   Pileckyte, Margarita ^b   Jedrychowicz Rosiak, Krystyna ^g   Baek, Inyoung ^h   Ghil, Jeehoon ^h  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b LITHUANIAN UNIVERSITY OF HEALTH SCIENCES   (Lithuania)

^c UNIVERSITY OF VETERINARY AND PHARMACEUTICAL SCIENCES   (Czech Republic)

^d Medica Pro Familia   (Poland)

^e Reumatika Centrum Reumatologii   (Poland)

^f ZDROWIE Osteo Medic   (Poland)

^g Mazowieckie Centrum Bada Klinicznych   (Poland)

^h Samsung Bioepis Co Ltd   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ALANINE AMINOTRANSFERASE; ANTIBODY; BIOSIMILAR AGENT; DRUG ANTIBODY; SB 5; UNCLASSIFIED DRUG; ANTIRHEUMATIC AGENT;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BONE EROSION; BRONCHITIS; CONTROLLED STUDY; CROHN DISEASE ACTIVITY INDEX; DAS28; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GLIOBLASTOMA; HEADACHE; HUMAN; IMMUNOGENICITY; INJECTION SITE REACTION; JOINT RADIOGRAPHY; LATENT TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SEMINOMA; SIDE EFFECT; SIMPLIFIED DISEASE ACTIVITY INDEX; SMALL CELL LUNG CANCER; SPINAL PAIN; TREATMENT DURATION; TREATMENT RESPONSE; TUBERCULOSIS; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; CLINICAL TRIAL; SEVERITY OF ILLNESS INDEX; TIME FACTOR; TREATMENT OUTCOME;

ADALIMUMAB; ADULT; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; DOUBLE-BLIND METHOD; DRUG SUBSTITUTION; FEMALE; HUMANS; MALE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 85046263133     PISSN: 23265191     EISSN: 23265205     Source Type: Journal    
DOI: 10.1002/art.40444     Document Type: Article

References (31)

1. McInnes IB, O'Dell JR. State-of-the-art: rheumatoid arthritis. Ann Rheum Dis 2010;69:1898–906.
2. Smolen JS, Landewe R, Bijlsma J, Burmester G, Chatzidionysiou K, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 2017;76:960–77.
3. Singh JA, Saag KG, Bridges SL Jr, Akl EA, Bannuru RR, Sullivan MC, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 2016;68:1–25.
4. Dorner T, Strand V, Castaneda-Hernandez G, Ferraccioli G, Isaacs JD, Kvien TK, et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 2013;72:322–8.
5. Graudal N, Hubeck-Graudal T, Faurschou M, Baslund B, Jürgens G. Combination therapy with and without tumor necrosis factor inhibitors in rheumatoid arthritis: a meta-analysis of randomized trials. Arthritis Care Res (Hoboken) 2015;67:1487–95.
6. Hirsch BR, Lyman GH. Biosimilars: a cure to the U.S. health care cost conundrum? Blood Rev 2014;28:263–8.
7. Humira (adalimumab) medication guide. North Chicago: AbbVie; 2016.
8. Shin D, Lee Y, Kim H, Kornicke T, Fuhr R. A randomized phase I comparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers. J Clin Pharm Ther 2017;42:672–8.
9. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727–35.
10. Weinblatt ME, Baranauskaite A, Niebrzydowski J, Dokoupilova E, Zielinska A, Jaworski J, et al. Phase III randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis. Arthritis Rheumatol 2018;70:40–8.
11. Moots R, Azevedo V, Coindreau JL, Dorner T, Mahgoub E, Mysler E, et al. Switching between reference biologics and biosimilars for the treatment of rheumatology, gastroenterology, and dermatology inflammatory conditions: considerations for the clinician. Curr Rheumatol Rep 2017;19:37.
12. Schiff M, Weaver A, Keystone E, Moreland L, Spencer-Green G. Comparison of ACR response, numeric ACR, and ACR AUC as measures of clinical improvement in RA clinical trials [abstract]. Arthritis Rheum 1999;42 Suppl:S81.
13. Prevoo ML, van ‘t Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight–joint counts: development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44–8.
14. Van Gestel AM, Prevoo ML, van ‘t Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis: comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism criteria. Arthritis Rheum 1996;39:34–40.
15. Smolen JS, Breedveld FC, Schiff MH, Kalden JR, Emery P, Eberl G, et al. A Simplified Disease Activity Index for rheumatoid arthritis for use in clinical practice. Rheumatology (Oxford) 2003;42:244–57.
16. Aletaha D, Nell VP, Stamm T, Uffmann M, Pflugbeil S, Machold K, et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther 2005;7:R796–806.
17. Van der Heijde DM, van Riel PL, Gribnau FW, Nuver-Zwart IH, van de Putte LB. Effects of hydroxychloroquine and sulphasalazine on progression of joint damage in rheumatoid arthritis. Lancet 1989;1:1036–8.
18. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 2006;54:26–37.
19. Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti–tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum 2004;50:1400–11.
20. Weinblatt ME, Keystone EC, Furst DE, Kavanaugh AF, Chartash EK, Segurado OG. Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study. Ann Rheum Dis 2006;65:753–9.
21. Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti–tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003;48:35–45.
22. Sampson HA, Munoz-Furlong A, Campbell RL, Adkinson NF Jr, Bock SA, Branum A, et al. Second symposium on the definition and management of anaphylaxis: summary report–second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. Ann Emerg Med 2006;47:373–80.
23. Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, Twisk JW, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 2011;305:1460–8.
24. Van de Putte LB, Atkins C, Malaise M, Sany J, Russell AS, van Riel PL, et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis 2004;63:508–16.
25. Lai Z, La Noce A. Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example. RMD Open 2016;2:e000154.
26. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. 2015. URL: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf.
27. Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis 2017;76:355–63.
28. Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Urena S, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis 2017;76:346–54.
29. Emery P, Vencovsky J, Sylwestrzak A, Leszczynski P, Porawska W, Stasiuk B, et al. Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4. Ann Rheum Dis 2017. E-pub ahead of print.
30. Cohen S, Genovese MC, Choy E, Perez-Ruiz F, Matsumoto A, Pavelka K, et al. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis 2017;76:1679–87.
31. Jorgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 2017;389:2304–16.