Kvien TK. Epidemiology and burden of illness of rheumatoid arthritis. PharmacoEconomics. 2004;22(2 Suppl 1):1–12.
Article
PubMed
Google Scholar
Markusse IM, Akdemir G, Dirven L, Goekoop-Ruiterman YP, van Groenendael JH, Han KH, et al. Long-term outcomes of patients with recent-onset rheumatoid arthritis after 10 years of tight controlled treatment: a randomized trial. Ann Intern Med. 2016;164(8):523–31. https://doi.org/10.7326/M15-0919.
Article
PubMed
Google Scholar
Sparks JA, Lin TC, Camargo CA Jr, Barbhaiya M, Tedeschi SK, Costenbader KH, et al. Rheumatoid arthritis and risk of chronic obstructive pulmonary disease or asthma among women: a marginal structural model analysis in the Nurses’ Health Study. Semin Arthritis Rheum. 2018;47(5):639–48. https://doi.org/10.1016/j.semarthrit.2017.09.005.
Article
PubMed
Google Scholar
Lundkvist J, Kastang F, Kobelt G. The burden of rheumatoid arthritis and access to treatment: health burden and costs. Eur J Health Econ. 2008;8(Suppl 2):S49–60. https://doi.org/10.1007/s10198-007-0088-8.
Article
PubMed
Google Scholar
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(6):960–77. https://doi.org/10.1136/annrheumdis-2016-210715.
Article
PubMed
Google Scholar
Jacobsson LT, Turesson C, Nilsson JA, Petersson IF, Lindqvist E, Saxne T, et al. Treatment with TNF blockers and mortality risk in patients with rheumatoid arthritis. Ann Rheum Dis. 2007;66(5):670–5. https://doi.org/10.1136/ard.2006.062497.
Article
PubMed
Google Scholar
Listing J, Kekow J, Manger B, Burmester GR, Pattloch D, Zink A, et al. Mortality in rheumatoid arthritis: the impact of disease activity, treatment with glucocorticoids, TNFalpha inhibitors and rituximab. Ann Rheum Dis. 2015;74(2):415–21. https://doi.org/10.1136/annrheumdis-2013-204021.
CAS
Article
PubMed
Google Scholar
AbbVie. AbbVie Reports Full-Year and Fourth-Quarter 2017 Financial Results 2018. https://news.abbvie.com/news/abbvie-reports-full-year-and-fourth-quarter-2017-financial-results.htm. Accessed April 2018.
European Medicines Agency. European public assessment report (EPAR) for Humira. 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000481/WC500050865.pdf. Accessed April 2018.
World Health Organization. Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs). 2016. http://www.who.int/biologicals/biotherapeutics/similar_biotherapeutic_products/en/. March 2017.
Salfield J, Kaymakcalan J, Tracey D, Roberts A, Kamen R. Generation of fully human anti-TNF antibody D2E7. Arthritis Rheum. 1998;41(9):S57-S.
Google Scholar
Cvetkovic RS, Scott LJ. Adalimumab: a review of its use in adult patients with rheumatoid arthritis. BioDrugs. 2006;20(5):293–311.
CAS
Article
PubMed
Google Scholar
Moots RJ, Xavier RM, Mok CC, Rahman MU, Tsai WC, Al-Maini MH, et al. The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: results from a multinational, real-world clinical practice, non-interventional study. PLoS One. 2017;12(4):e0175207. https://doi.org/10.1371/journal.pone.0175207.
CAS
Article
PubMed
PubMed Central
Google Scholar
Keystone EC, Breedveld FC, van der Heijde D, Landewe R, Florentinus S, Arulmani U, et al. Longterm effect of delaying combination therapy with tumor necrosis factor inhibitor in patients with aggressive early rheumatoid arthritis: 10-year efficacy and safety of adalimumab from the randomized controlled PREMIER trial with open-label extension. J Rheumatol. 2014;41(1):5–14. https://doi.org/10.3899/jrheum.130543.
CAS
Article
PubMed
Google Scholar
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(6):753–9. https://doi.org/10.1136/ard.2005.044404.
CAS
Article
PubMed
Google Scholar
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(5):508–16. https://doi.org/10.1136/ard.2003.013052.
CAS
Article
PubMed
PubMed Central
Google Scholar
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(1):26–37. https://doi.org/10.1002/art.21519.
CAS
Article
PubMed
Google Scholar
Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum. 2003;48(1):35–45. https://doi.org/10.1002/art.10697.
CAS
Article
PubMed
Google Scholar
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(5):1400–11. https://doi.org/10.1002/art.20217.
CAS
Article
PubMed
Google Scholar
Furst DE, Schiff MH, Fleischmann RM, Strand V, Birbara CA, Compagnone D, et al. Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis). J Rheumatol. 2003;30(12):2563–71.
CAS
PubMed
Google Scholar
Smolen JS, Burmester GR, Combe B, Curtis JR, Hall S, Haraoui B, et al. Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study. Lancet. 2016;388(10061):2763–74. https://doi.org/10.1016/S0140-6736(16)31651-8.
CAS
Article
PubMed
Google Scholar
Fleischmann R, Mysler E, Hall S, Kivitz AJ, Moots RJ, Luo Z, et al. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Lancet. 2017;390(10093):457–68. https://doi.org/10.1016/S0140-6736(17)31618-5.
CAS
Article
PubMed
Google Scholar
Weinblatt ME, Schiff M, Valente R, van der Heijde D, Citera G, Zhao C, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum. 2013;65(1):28–38. https://doi.org/10.1002/art.37711.
CAS
Article
PubMed
PubMed Central
Google Scholar
Porter D, van Melckebeke J, Dale J, Messow CM, McConnachie A, Walker A, et al. Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): an open-label, randomised controlled, non-inferiority, trial. Lancet. 2016;388(10041):239–47. https://doi.org/10.1016/S0140-6736(16)00380-9.
CAS
Article
PubMed
Google Scholar
Singh JA, Christensen R, Wells GA, Suarez-Almazor ME, Buchbinder R, Lopez-Olivo MA, et al. A network meta-analysis of randomized controlled trials of biologics for rheumatoid arthritis: a Cochrane overview. CMAJ. 2009;181(11):787–96. https://doi.org/10.1503/cmaj.091391.
Article
PubMed
PubMed Central
Google Scholar
Jorgensen TS, Turesson C, Kapetanovic M, Englund M, Turkiewicz A, Christensen R, et al. EQ-5D utility, response and drug survival in rheumatoid arthritis patients on biologic monotherapy: a prospective observational study of patients registered in the south Swedish SSATG registry. PLoS One. 2017;12(2):e0169946. https://doi.org/10.1371/journal.pone.0169946.
CAS
Article
PubMed
PubMed Central
Google Scholar
Hetland ML, Christensen IJ, Tarp U, Dreyer L, Hansen A, Hansen IT, et al. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum. 2010;62(1):22–32. https://doi.org/10.1002/art.27227.
CAS
Article
PubMed
PubMed Central
Google Scholar
Burmester GR, Lin Y, Patel R, van Adelsberg J, Mangan EK, Graham NM, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis. 2017;76(5):840–7. https://doi.org/10.1136/annrheumdis-2016-210310.
CAS
Article
PubMed
Google Scholar
Gabay C, Emery P, van Vollenhoven R, Dikranian A, Alten R, Pavelka K, et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013;381(9877):1541–50. https://doi.org/10.1016/S0140-6736(13)60250-0.
CAS
Article
PubMed
Google Scholar
Taylor PC, Keystone EC, van der Heijde D, Weinblatt ME, Del Carmen ML, Reyes Gonzaga J, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2017;376(7):652–62. https://doi.org/10.1056/NEJMoa1608345.
CAS
Article
PubMed
Google Scholar
Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. 2015. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm290967.htm. March 2017.
European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2015 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp. March 2017.
Genovese MC, Glover J, Matsunaga N, Chisholm D, Alten R. Efficacy, safety and immunogenicity in randomized, double-blind (DB) and open label extension (OLE) studies comparing FKB327, an adalimumab biosimilar, with the adalimumab reference product (Humira (R); RP) in patients (pts) with active rheumatoid arthritis (RA). Arthritis Rheumatol. 2017;69:2.
Google Scholar
Alten R, Glover J, Matsunaga N, Chisholm D, Genovese M. Efficacy and safety results of a phase iii study comparing FKB327, an adalimumab biosimilar, with the adalimumab reference product in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017;76:59. https://doi.org/10.1136/annrheumdis-2017-eular.2220.
Article
Google Scholar
Blauvelt A, Lacour JP, Fowler J, Schuck E, Jauch-Lembach J, Balfour A, et al. Long-term efficacy, safety and immunogenicity results from a randomized, double-blind, phase III confirmatory efficacy and safety study comparing GP2017, a proposed biosimilar, with reference adalimumab. Arthritis Rheum. 2017;69:4.
Google Scholar
Sandoz. Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the European Medicines Agency. 2017. https://www.sandoz.com/news/media-releases/sandoz-proposed-biosimilars-adalimumab-and-infliximab-accepted-regulatory-review. Apri 2018.
Jamshidi A, Gharibdoost F, Vojdanian M, Soroosh SG, Soroush M, Ahmadzadeh A, et al. A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA(R)) to the reference product (Humira(R)) in patients with active rheumatoid arthritis. Arthritis Res Ther. 2017;19(1):168. https://doi.org/10.1186/s13075-017-1371-4.
Article
PubMed
PubMed Central
Google Scholar
Jani RH, Gupta R, Bhatia G, Rathi G, Ashok Kumar P, Sharma R, et al. A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis. Int J Rheum Dis. 2016;19(11):1157–68. https://doi.org/10.1111/1756-185X.12711.
CAS
Article
PubMed
Google Scholar
Business Standard. Torrent launches world's second biosimilar of generic auto-immune drug. 2016. http://www.business-standard.com/article/companies/torrent-launches-world-s-second-biosimilar-of-generic-auto-immune-drug-116011100615_1.html. April 2018.
Kaur P, Chow V, Zhang N, Moxness M, Kaliyaperumal A, Markus R. A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab. Ann Rheum Dis. 2017;76(3):526–33. https://doi.org/10.1136/annrheumdis-2015-208914.
CAS
Article
PubMed
PubMed Central
Google Scholar
Velayudhan J, Chen YF, Rohrbach A, Pastula C, Maher G, Thomas H, et al. Demonstration of functional similarity of proposed biosimilar ABP 501 to adalimumab. BioDrugs. 2016;30(4):339–51. https://doi.org/10.1007/s40259-016-0185-2.
CAS
Article
PubMed
PubMed Central
Google Scholar
Liu J, Eris T, Li C, Cao S, Kuhns S. Assessing analytical similarity of proposed Amgen biosimilar ABP 501 to adalimumab. BioDrugs. 2016;30(4):321–38. https://doi.org/10.1007/s40259-016-0184-3.
CAS
Article
PubMed
PubMed Central
Google Scholar
Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: a randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol. 2017;76(6):1093–102. https://doi.org/10.1016/j.jaad.2016.12.014.
CAS
Article
PubMed
Google Scholar
• 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(10):1679–87. https://doi.org/10.1136/annrheumdis-2016-210459. This is a large, high quality randomised controlled trial of an adalimumab biosimilar
Article
PubMed
PubMed Central
Google Scholar
European Medicines Agency. European public assessment report: SOLYMBIC. 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004373/WC500225367.pdf. Accessed April 2018.
European Medicines Agency. European public assessment report: AMGEVITA. 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004212/WC500225231.pdf. Accessed April 2018.
Wynne C, Altendorfer M, Sonderegger I, Gheyle L, Ellis-Pegler R, Buschke S, et al. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE(R)-PK) in healthy subjects. Expert Opin Investig Drugs. 2016;25(12):1361–70. https://doi.org/10.1080/13543784.2016.1255724.
CAS
Article
PubMed
Google Scholar
• Cohen SB, Alonso-Ruiz A, Klimiuk PA, Lee EC, Peter N, Sonderegger I, et al. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study. Ann Rheum Dis. 2018; https://doi.org/10.1136/annrheumdis-2017-212245. This is large, high quality randomised controlled trial of an adalimumab biosimilar
European Medicines Agency. European public assessment report: Cyltezo. 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004319/WC500238609.pdf. Accessed April 2018.
Shin D, Lee Y, Kim H, Körnicke 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.
CAS
Article
PubMed
Google Scholar
• 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 Rheum. 2018;70(1):40–8. https://doi.org/10.1002/art.40336. This is large, high quality randomised controlled trial of an adalimumab biosimilar
CAS
Article
Google Scholar
European Medicines Agency. European public assessment report: Imraldi. 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004279/WC500233922.pdf. Accessed April 2018.
Griffiths CEM, Thaci D, Gerdes S, Arenberger P, Pulka G, Kingo K, et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2017;176(4):928–38. https://doi.org/10.1111/bjd.15152.
CAS
Article
PubMed
Google Scholar
Leonardi CL, Powers JL, Matheson RT, Goffe BS, Zitnik R, Wang A, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003;349(21):2014–22. https://doi.org/10.1056/NEJMoa030409.
CAS
Article
PubMed
Google Scholar
Tyring S, Gottlieb A, Papp K, Gordon K, Leonardi C, Wang A, et al. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet. 2006;367(9504):29–35. https://doi.org/10.1016/S0140-6736(05)67763-X.
CAS
Article
PubMed
Google Scholar
Menter A, Tyring SK, Gordon K, Kimball AB, Leonardi CL, Langley RG, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58(1):106–15. https://doi.org/10.1016/j.jaad.2007.09.010.
Article
PubMed
Google Scholar
Saurat JH, Stingl G, Dubertret L, Papp K, Langley RG, Ortonne JP, et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol. 2008;158(3):558–66. https://doi.org/10.1111/j.1365-2133.2007.08315.x.
CAS
Article
PubMed
Google Scholar
Moots RJ, Curiale C, Petersel D, Rolland C, Jones H, Mysler E. Efficacy and safety outcomes for originator TNF inhibitors and biosimilars in rheumatoid arthritis and psoriasis trials: a systematic literature review. BioDrugs. 2018; https://doi.org/10.1007/s40259-018-0283-4.
CAS
Article
PubMed
Google Scholar
Smolen JS, Kay J, Doyle MK, Landewe R, Matteson EL, Wollenhaupt J, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009;374(9685):210–21. https://doi.org/10.1016/S0140-6736(09)60506-7.
CAS
Article
PubMed
Google Scholar
Karlsson JA, Kristensen LE, Kapetanovic MC, Gulfe A, Saxne T, Geborek P. Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment Group Register. Rheumatology. 2008;47(4):507–13. https://doi.org/10.1093/rheumatology/ken034.
CAS
Article
PubMed
Google Scholar
• 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(6):37. https://doi.org/10.1007/s11926-017-0658-4. Practical discussion on switching between bio-originator and biosimilars
Article
PubMed
PubMed Central
Google Scholar
Weinblatt ME, Baranauskaite A, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, et al. Switching from reference adalimumab to SB5 (adalimumab biosimilar) in patients with rheumatoid arthritis: fifty-two-week phase III randomized study results. Arthritis Rheumatol. 2018;70:832–40. https://doi.org/10.1002/art.40444.
CAS
Article
PubMed
PubMed Central
Google Scholar
Cohen S, Pablos JL, Wang H, Muller GA, Kivitz A, Matsumoto A, et al. ABP 501 biosmilar to adalimumab: final safety, immunogenicity, and efficacy results from an open-label extension study. Ann Rheum Dis. 2017;76:834–5. https://doi.org/10.1136/annrheumdis-2017-eular.3288.
Article
Google Scholar
Cohen S, Pablos JL, Zhang N, Rizzo W, Muller G, Padmanaban D, et al. ABP 501 long-term safety/efficacy: interim results from an open-label extension study. Arthritis Rheumatol. 2016;68:2.
Google Scholar