378
Views
39
CrossRef citations to date
0
Altmetric
Review

Infliximab and biosimilar infliximab in psoriasis: efficacy, loss of efficacy, and adverse events

, , &
Pages 2491-2502 | Published online: 23 Jul 2019

References

  • Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826–850. doi:10.1016/j.jaad.2008.02.03918423260
  • Ding X, Wang T, Shen Y, et al. Prevalence of psoriasis in China: a population-based study in six cities. Eur J Dermatol. 2012;22(5):663–667. doi:10.1684/ejd.2012.180222910173
  • Parisi R, Symmons DP, Griffiths CE, Ashcroft DM. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013;133(2):377–385. doi:10.1038/jid.2012.33923014338
  • Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet. 2007;370(9583):263–271. doi:10.1016/S0140-6736(07)61128-317658397
  • Asadullah K, Sterry W, Trefzer U. Cytokines: interleukin and interferon therapy in dermatology. Clin Exp Dermatol. 2002;27(7):578–584.12464153
  • Mahil SK, Capon F, Barker JN. Update on psoriasis immunopathogenesis and targeted immunotherapy. Semin Immunopathol. 2016;38(1):11–27. doi:10.1007/s00281-015-0539-826573299
  • Kerdel FA, Strober BE. Tumor necrosis factor inhibitors in psoriasis: an update. Semin Cutan Med Surg. 2014;33(2 Suppl 2):S31–S36. doi:10.12788/j.sder.006624979543
  • Pathirana D, Ormerod AD, Saiag P, et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venereol. 2009;23(Suppl 2):1–70. doi:10.1111/j.1468-3083.2009.03389.x
  • Nast A, Sporbeck B, Rosumeck S, et al. Which antipsoriatic drug has the fastest onset of action? Systematic review on the rapidity of the onset of action. J Invest Dermatol. 2013;133(8):1963–1970. doi:10.1038/jid.2013.7823426133
  • de Vries AC, Thio HB, de Kort WJ, et al. A prospective randomized controlled trial comparing infliximab and etanercept in patients with moderate-to-severe chronic plaque-type psoriasis: the Psoriasis Infliximab vs. Etanercept Comparison Evaluation (PIECE) study. Br J Dermatol. 2017;176(3):624–633. doi:10.1111/bjd.1486727416891
  • Antoni C, Krueger GG, de Vlam K, et al. Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Ann Rheum Dis. 2005;64(8):1150–1157. doi:10.1136/ard.2004.03226815677701
  • Antoni CE, Kavanaugh A, Kirkham B, et al. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT). Arthritis Rheum. 2005;52(4):1227–1236. doi:10.1002/art.2096715818699
  • Reich K, Wozel G, Zheng H, van Hoogstraten HJ, Flint L, Barker J. Efficacy and safety of infliximab as continuous or intermittent therapy in patients with moderate-to-severe plaque psoriasis: results of a randomized, long-term extension trial (RESTORE2). Br J Dermatol. 2013;168(6):1325–1334. doi:10.1111/bjd.1240423621698
  • Menter A, Feldman SR, Weinstein GD, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2007;56(1):31.e31-15. doi:10.1016/j.jaad.2006.07.017
  • Kim WB, Marinas JE, Qiang J, Shahbaz A, Greaves S, Yeung J. Adverse events resulting in withdrawal of biologic therapy for psoriasis in real-world clinical practice: a Canadian multicenter retrospective study. J Am Acad Dermatol. 2015;73(2):237–241. doi:10.1016/j.jaad.2015.04.02326026334
  • Kleyn CE, Griffiths CE. Infliximab for the treatment of psoriasis. Expert Opin Biol Ther. 2006;6(8):797–805. doi:10.1517/14712598.6.8.79716856801
  • Lecluse LL, Piskin G, Mekkes JR, Bos JD, de Rie MA. Review and expert opinion on prevention and treatment of infliximab-related infusion reactions. Br J Dermatol. 2008;159(3):527–536. doi:10.1111/j.1365-2133.2008.08728.x18627374
  • Wee JS, Petrof G, Jackson K, Barker JN, Smith CH. Infliximab for the treatment of psoriasis in the U.K.: 9 years’ experience of infusion reactions at a single centre. Br J Dermatol. 2012;167(2):411–416. doi:10.1111/j.1365-2133.2012.10931.x22404545
  • Cheifetz A, Smedley M, Martin S, et al. The incidence and management of infusion reactions to infliximab: a large center experience. Am J Gastroenterol. 2003;98(6):1315–1324. doi:10.1111/j.1572-0241.2003.07457.x12818276
  • Sehgal VN, Pandhi D, Khurana A. Biologics in dermatology: adverse effects. Int J Dermatol. 2015;54(12):1442–1460. doi:10.1111/ijd.1280226147909
  • Reich K, Nestle FO, Papp K, et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet. 2005;366(9494):1367–1374. doi:10.1016/S0140-6736(05)67566-616226614
  • Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn’s disease. N Engl J Med. 2003;348(7):601–608. doi:10.1056/NEJMoa02088812584368
  • Hanauer SB, Wagner CL, Bala M, et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn’s disease. Clin Gastroenterol Hepatol. 2004;2(7):542–553.15224278
  • Torii H, Nakano M, Yano T, Kondo K, Nakagawa H. Efficacy and safety of dose escalation of infliximab therapy in Japanese patients with psoriasis: results of the SPREAD study. J Dermatol. 2017;44(5):552–559. doi:10.1111/1346-8138.1369827882586
  • Vermeire S, Noman M, Van Assche G, Baert F, D’Haens G, Rutgeerts P. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn’s disease. Gut. 2007;56(9):1226–1231. doi:10.1136/gut.2006.09997817229796
  • Candon S, Mosca A, Ruemmele F, Goulet O, Chatenoud L, Cezard JP. Clinical and biological consequences of immunization to infliximab in pediatric Crohn’s disease. Clin Immunol. 2006;118(1):11–19. doi:10.1016/j.clim.2005.07.01016125467
  • Dommasch ED, Abuabara K, Shin DB, Nguyen J, Troxel AB, Gelfand JM. The risk of infection and malignancy with tumor necrosis factor antagonists in adults with psoriatic disease: a systematic review and meta-analysis of randomized controlled trials. J Am Acad Dermatol. 2011;64(6):1035–1050. doi:10.1016/j.jaad.2010.09.73421315483
  • Gardam MA, Keystone EC, Menzies R, et al. Anti-tumour necrosis factor agents and tuberculosis risk: mechanisms of action and clinical management. Lancet Infect Dis. 2003;3(3):148–155.12614731
  • Wallis RS. Biologics and infections: lessons from tumor necrosis factor blocking agents. Infect Dis Clin North Am. 2011;25(4):895–910. doi:10.1016/j.idc.2011.08.00222054762
  • Tubach F, Salmon D, Ravaud P, et al. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: the three-year prospective French research axed on tolerance of biotherapies registry. Arthritis Rheum. 2009;60(7):1884–1894. doi:10.1002/art.2463219565495
  • Wallis RS. Mathematical modeling of the cause of tuberculosis during tumor necrosis factor blockade. Arthritis Rheum. 2008;58(4):947–952. doi:10.1002/art.2328518383389
  • Smith CH, Jabbar-Lopez ZK, Yiu ZZ, et al. British association of dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017;177(3):628–636. doi:10.1111/bjd.1566528513835
  • Doherty SD, Van Voorhees A, Lebwohl MG, et al. National psoriasis foundation consensus statement on screening for latent tuberculosis infection in patients with psoriasis treated with systemic and biologic agents. J Am Acad Dermatol. 2008;59(2):209–217. doi:10.1016/j.jaad.2008.03.02318485527
  • Mariette X, Salmon D. French guidelines for diagnosis and treating latent and active tuberculosis in patients with RA treated with TNF blockers. Ann Rheum Dis. 2003;62(8):791. doi:10.1136/ard.62.8.79112860745
  • British Thoracic Society Standards of Care Committee. BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-TNF-alpha treatment. Thorax. 2005;60(10):800–805. doi:10.1136/thx.2005.04679716055611
  • Rychly DJ, DiPiro JT. Infections associated with tumor necrosis factor-alpha antagonists. Pharmacotherapy. 2005;25(9):1181–1192. doi:10.1592/phco.2005.25.9.118116164393
  • Atzeni F, Sarzi-Puttini P, Sebastiani M, et al.; GISEA group. Rate of serious infections in spondyloarthropathy patients treated with anti-tumour necrosis factor drugs: a survey from the Italian registry GISEA. Clin Exp Rheumatol. 2019;11.
  • Dogra S, Khullar G. Tumor necrosis factor-alpha antagonists: side effects and their management. Indian J Dermatol Venereol Leprol. 2013;79(Suppl 7):S35–S46. doi:10.4103/0378-6323.11552623974693
  • Poulalhon N, Begon E, Lebbe C, et al. A follow-up study in 28 patients treated with infliximab for severe recalcitrant psoriasis: evidence for efficacy and high incidence of biological autoimmunity. Br J Dermatol. 2007;156(2):329–336. doi:10.1111/j.1365-2133.2006.07639.x17223874
  • Gottlieb AB, Evans R, Li S, et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004;51(4):534–542. doi:10.1016/j.jaad.2004.02.02115389187
  • Dang LJ, Lubel JS, Gunatheesan S, Hosking P, Su J. Drug-induced lupus and autoimmune hepatitis secondary to infliximab for psoriasis. Australas J Dermatol. 2014;55(1):75–79. doi:10.1111/ajd.1205423651182
  • Poulin Y, Therien G. Drug-induced hepatitis and lupus during infliximab treatment for psoriasis: case report and literature review. J Cutan Med Surg. 2010;14(2):100–104. doi:10.2310/7750.2009.0900720338127
  • Patel RV, Clark LN, Lebwohl M, Weinberg JM. Treatments for psoriasis and the risk of malignancy. J Am Acad Dermatol. 2009;60(6):1001–1017. doi:10.1016/j.jaad.2008.12.03119344980
  • Fiorentino D, Ho V, Lebwohl MG, et al. Risk of malignancy with systemic psoriasis treatment in the psoriasis longitudinal assessment registry. J Am Acad Dermatol. 2017;77(5):845–854.e845. doi:10.1016/j.jaad.2017.07.01328893407
  • Shear NH, Hartmann M, Toledo-Bahena M, et al. Long-term efficacy and safety of infliximab maintenance therapy in patients with plaque-type psoriasis in real-world practice. Br J Dermatol. 2014;171(3):631–641. doi:10.1111/bjd.1300424673357
  • Ohtsuki M, Terui T, Ozawa A, et al. Japanese guidance for use of biologics for psoriasis (the 2013 version). J Dermatol. 2013;40(9):683–695. doi:10.1111/1346-8138.1223924033880
  • Bessissow T, Renard M, Hoffman I, Vermeire S, Rutgeerts P, Van Assche G. Review article: non-malignant haematological complications of anti-tumour necrosis factor alpha therapy. Aliment Pharmacol Ther. 2012;36(4):312–323. doi:10.1111/j.1365-2036.2012.05189.x22725726
  • Gottlieb AB, Kalb RE, Blauvelt A, et al. The efficacy and safety of infliximab in patients with plaque psoriasis who had an inadequate response to etanercept: results of a prospective, multicenter, open-label study. J Am Acad Dermatol. 2012;67(4):642–650. doi:10.1016/j.jaad.2011.10.02022153792
  • Tristano AG. Neurological adverse events associated with anti-tumor necrosis factor alpha treatment. J Neurol. 2010;257(9):1421–1431. doi:10.1007/s00415-010-5591-720495815
  • Rungapiromnan W, Yiu ZZN, Warren RB, Griffiths CEM, Ashcroft DM. Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials. Br J Dermatol. 2017;176(4):890–901. doi:10.1111/bjd.1496427518205
  • Bissonnette R, Kerdel F, Naldi L, et al. Evaluation of risk of major adverse cardiovascular events with biologic therapy in patients with psoriasis. J Drugs Dermatol. 2017;16(10):1002–1013.29036254
  • Mössner R, Thaci D, Mohr J, et al. Manifestation of palmoplantar pustulosis during or after infliximab therapy for plaque-type psoriasis: report on five cases. Arch Dermatol Res. 2008;300(3):101–105. doi:10.1007/s00403-008-0831-818239925
  • Shmidt E, Wetter DA, Ferguson SB, Pittelkow MR. Psoriasis and palmoplantar pustulosis associated with tumor necrosis factor-alpha inhibitors: the Mayo Clinic experience, 1998 to 2010. J Am Acad Dermatol. 2012;67(5):e179–e185. doi:10.1016/j.jaad.2011.05.03821752492
  • Sherlock ME, Walters T, Tabbers MM, et al. Infliximab-induced psoriasis and psoriasiform skin lesions in pediatric Crohn disease and a potential association with IL-23 receptor polymorphisms. J Pediatr Gastroenterol Nutr. 2013;56(5):512–518. doi:10.1097/MPG.0b013e31828390ba23274341
  • Wollina U, Hansel G, Koch A, Schonlebe J, Kostler E, Haroske G. Tumor necrosis factor-alpha inhibitor-induced psoriasis or psoriasiform exanthemata: first 120 cases from the literature including a series of six new patients. Am J Clin Dermatol. 2008;9(1):1–14. doi:10.2165/00128071-200809010-0000118092839
  • Adisen E, Aral A, Aybay C, Gurer MA. Anti-infliximab antibody status and its relation to clinical response in psoriatic patients: A pilot study. J Dermatol. 2010;37(8):708–713. doi:10.1111/j.1346-8138.2010.00882.x20649712
  • Torii H, Nakagawa H. Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial. J Dermatol Sci. 2010;59(1):40–49. doi:10.1016/j.jdermsci.2010.04.01420547039
  • Bito T, Nishikawa R, Hatakeyama M, et al. Influence of neutralizing antibodies to adalimumab and infliximab on the treatment of psoriasis. Br J Dermatol. 2014;170(4):922–929. doi:10.1111/bjd.1279124329764
  • Takahashi H, Tsuji H, Ishida-Yamamoto A, Iizuka H. Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis. J Dermatol. 2013;40(1):39–42. doi:10.1111/j.1346-8138.2012.01679.x23039179
  • Balsa A, Sanmarti R, Rosas J, et al. Drug immunogenicity in patients with inflammatory arthritis and secondary failure to tumour necrosis factor inhibitor therapies: the REASON study. Rheumatology (Oxford). 2018;57(4):688–693. doi:10.1093/rheumatology/kex47429365183
  • Kui R, Gal B, Gaal M, Kiss M, Kemeny L, Gyulai R. Presence of antidrug antibodies correlates inversely with the plasma tumor necrosis factor (TNF)-alpha level and the efficacy of TNF-inhibitor therapy in psoriasis. J Dermatol. 2016;43(9):1018–1023. doi:10.1111/1346-8138.1330126892625
  • Torii H, Sato N, Yoshinari T, Nakagawa H. Dramatic impact of a psoriasis area and severity index 90 response on the quality of life in patients with psoriasis: an analysis of Japanese clinical trials of infliximab. J Dermatol. 2012;39(3):253–259. doi:10.1111/j.1346-8138.2011.01459.x22211581
  • Agency EM. Questions and answers on biosimilar medicines (similar biological medicinal products). EMA/837805/2011; 2012.
  • Jørgensen KK, Olsen IC, Goll GL, 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(10086):2304–2316. doi:10.1016/S0140-6736(17)30068-528502609
  • Komaki Y, Yamada A, Komaki F, et al. Efficacy, safety and pharmacokinetics of biosimilars of anti-tumor necrosis factor-α agents in rheumatic diseases; A systematic review and meta-analysis. J Autoimmun. 2017;79:4–16. doi:10.1016/j.jaut.2017.02.00328209290
  • Yoo DH, Racewicz A, Brzezicki J, et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016;18:1. doi:10.1186/s13075-016-0981-626732314
  • Jung SK, Lee KH, Jeon JW, et al. Physicochemical characterization of Remsima. mAbs. 2014;6(5):1163–1177. doi:10.4161/mabs.3222125517302
  • Layegh Z, Ruwaard J, Hebing RCF, et al. Efficacious transition from reference infliximab to biosimilar infliximab in clinical practice. Int J Rheum Dis. 2019;22:869–873. doi:10.1111/1756-185X.1351230767391
  • O’Toole A, Moss AC. Optimizing biologic agents in ulcerative Colitis and Crohn’s disease. Curr Gastroenterol Rep. 2015;17. doi:10.1007/s11894-015-0453-1
  • Dapavo P, Vujic I, Fierro MT, Quaglino P, Sanlorenzo M. The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;75(4):736–739. doi:10.1016/j.jaad.2016.04.06827473452
  • Gisondi P, Bianchi L, Conti A, et al. Infliximab biosimilar CT-P13 in the treatment of chronic plaque psoriasis: data from the Psobiosimilars registry. Br J Dermatol. 2017;177(6):e325–e326. doi:10.1111/bjd.1565928498543
  • Lorenzin M, Ortolan A, Frallonardo P, Oliviero F, Punzi L, Ramonda R. Predictors of response and drug survival in ankylosing spondylitis patients treated with infliximab. BMC Musculoskelet Disord. 2015;16:166.26205000
  • Pink AE, Fonia A, Allen MH, Smith CH, Barker JN. Antinuclear antibodies associate with loss of response to antitumour necrosis factor-alpha therapy in psoriasis: a retrospective, observational study. Br J Dermatol. 2010;162(4):780–785. doi:10.1111/j.1365-2133.2009.09563.x19863499
  • Hoffmann JH, Hartmann M, Enk AH, Hadaschik EN. Autoantibodies in psoriasis as predictors for loss of response and anti-infliximab antibody induction. Br J Dermatol. 2011;165(6):1355–1358. doi:10.1111/j.1365-2133.2011.10555.x21801160
  • Reich K, Griffiths C, Barker J, et al. Recommendations for the long-term treatment of psoriasis with infliximab: a dermatology expert group consensus. Dermatology. 2008;217(3):268–275. doi:10.1159/00014997018685261
  • Luber AJ, Tsui CL, Heinecke GM, Lebwohl MG, Levitt JO. Long-term durability and dose escalation patterns in infliximab therapy for psoriasis. J Am Acad Dermatol. 2014;70(3):525–532. doi:10.1016/j.jaad.2013.10.05924388425
  • Vena G, Loconsole F, Mastrandrea V, Buquicchio R, Cassano N. Therapeutic hotline: re-induction may be useful to manage psoriasis relapse during long-term maintenance treatment with infliximab: a retrospective analysis. Dermatol Ther. 2010;23(2):199–202. doi:10.1111/j.1529-8019.2010.01315.x20415828
  • Dalaker M, Bonesronning JH. Long-term maintenance treatment of moderate-to-severe plaque psoriasis with infliximab in combination with methotrexate or azathioprine in a retrospective cohort. J Eur Acad Dermatol Venereol. 2009;23(3):277–282. doi:10.1111/j.1468-3083.2008.03039.x19207642
  • Torii H, Nakagawa H. Long-term study of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. J Dermatol. 2011;38(4):321–334.21544940
  • Barker J, Hoffmann M, Wozel G, et al. Efficacy and safety of infliximab vs. methotrexate in patients with moderate-to-severe plaque psoriasis: results of an open-label, active-controlled, randomized trial (RESTORE1). Br J Dermatol. 2011;165(5):1109–1117. doi:10.1111/j.1365-2133.2011.10615.x21910713