Golimumab (anti-TNF monoclonal antibody): where we stand today

References

• Pelechas E, Voulgari PV, Drosos AA. Golimumab for rheumatoid arthritis. J Clin Med. 2019 Mar 20;8(3):387. doi:10.3390/jcm8030387.
   PubMed Web of Science ®Google Scholar
• Shealy DJ, Cai A, Staquet K, Baker A, Lacy ER, Johns L, Vafa O, Gunn G, Tam S, Sague S, et al. Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor α. mAbs. 2010 Aug;2(4):428–39. doi:10.4161/mabs.12304.
   PubMed Web of Science ®Google Scholar
• Wong M, Ziring D, Korin Y, Desai S, Kim S, Lin J, Gjertson D, Braun J, Reed E, Singh RR, et al. TNFalpha blockade in human diseases: mechanisms and future directions. Clin Immunol Orlando Fla. 2008 Feb;126(2):121–36. doi:10.1016/j.clim.2007.08.013.
   PubMed Web of Science ®Google Scholar
• Mantravadi S, Ogdie A, Kraft WK. Tumor necrosis factor inhibitors in psoriatic arthritis. Expert Rev Clin Pharmacol. 2017 Aug;10(8):899–910. doi:10.1080/17512433.2017.1329009.
   PubMed Web of Science ®Google Scholar
• Mitoma H, Horiuchi T, Tsukamoto H, Ueda N. Molecular mechanisms of action of anti-TNF-α agents - Comparison among therapeutic TNF-α antagonists. Cytokine. 2018;101:56–63. doi:10.1016/j.cyto.2016.08.014.
   PubMed Web of Science ®Google Scholar
• Olesen CM, Coskun M, Peyrin-Biroulet L, Nielsen OH. Mechanisms behind efficacy of tumor necrosis factor inhibitors in inflammatory bowel diseases. Pharmacol Ther. 2016 Mar;159:110–19. doi:10.1016/j.pharmthera.2016.01.001.
   PubMed Web of Science ®Google Scholar
• Steeland S, Libert C, Vandenbroucke RE, New A. Venue of TNF targeting. Int J Mol Sci. 2018 May 11;19(5):1–55.
   PubMed Web of Science ®Google Scholar
• Nguyen DX, Ehrenstein MR. Anti-TNF drives regulatory T cell expansion by paradoxically promoting membrane TNF–TNF-RII binding in rheumatoid arthritis. J Exp Med. 2016 Jun 27;213(7):1241–53. doi:10.1084/jem.20151255.
   PubMed Web of Science ®Google Scholar
• Flamant M, Paul S, Roblin X. Golimumab for the treatment of ulcerative colitis. Expert Opin Biol Ther. 2017 Jul 3;17(7):879–86. doi:10.1080/14712598.2017.1327576.
   PubMed Web of Science ®Google Scholar
• Nestorov I. Clinical pharmacokinetics of TNF antagonists: how do they differ? Semin Arthritis Rheum. 2005 Apr;34(5 Suppl1):12–18. doi:10.1016/j.semarthrit.2005.01.004.
   PubMed Web of Science ®Google Scholar
• Baddley JW, Cantini F, Goletti D, Gómez-Reino JJ, Mylonakis E, San-Juan R, Fernandez-Ruiz M, Torre-Cisneros J. ESCMID study group for infections in compromised hosts (ESGICH) consensus document on the safety of targeted and biological therapies: an infectious diseases perspective (Soluble immune effector molecules [I]: anti-tumor necrosis factor-α agents). Clin Microbiol Infect Off Publ Eur Soc Clin Microbiol Infect Dis. 2018Jun;24(Suppl 2): S10–20.
   PubMed Web of Science ®Google Scholar
• Chu CQ, Field M, Feldmann M, Maini RN. Localization of tumor necrosis factor alpha in synovial tissues and at the cartilage-pannus junction in patients with rheumatoid arthritis. Arthritis Rheum. 1991 Sep;34(9):1125–32. doi:10.1002/art.1780340908.
   PubMed Web of Science ®Google Scholar
• Cornillie F, Shealy D, D’Haens G, Geboes K, Van Assche G, Ceuppens J, Wagner C, Schaible T, Plevy SE, Targan SR, et al. Infliximab induces potent anti-inflammatory and local immunomodulatory activity but no systemic immune suppression in patients with Crohn’s disease. Aliment Pharmacol Ther. 2001 Apr;15(4):463–73. doi:10.1046/j.1365-2036.2001.00956.x.
   PubMed Web of Science ®Google Scholar
• Bonifati C, Ameglio F. Cytokines in psoriasis. Int J Dermatol. 1999 Apr;38(4):241–51. doi:10.1046/j.1365-4362.1999.00622.x.
   PubMed Web of Science ®Google Scholar
• Knight DM, Trinh H, Le J, Siegel S, Shealy D, McDonough M, Scallon B, Moore MA, Vilcek J, Daddona P, et al. Construction and initial characterization of a mouse-human chimeric anti-TNF antibody. Mol Immunol. 1993 Nov 1;30(16):1443–53. doi:10.1016/0161-5890(93)90106-L.
   PubMed Web of Science ®Google Scholar
• Hutas G. Golimumab, a fully human monoclonal antibody against TNFalpha. Curr Opin Mol Ther. 2008 Aug;10(4):393–406.
   PubMedGoogle Scholar
• Hassett B, Singh E, Mahgoub E, O’Brien J, Vicik SM, Fitzpatrick B. Manufacturing history of etanercept (Enbrel®): consistency of product quality through major process revisions. mAbs. 2017 Nov 29;10(1):159–65. doi:10.1080/19420862.2017.1388483.
   PubMed Web of Science ®Google Scholar
• Lee JU, Shin W, Son JY, Yoo K-Y, Heo Y-S. Molecular basis for the neutralization of tumor necrosis factor α by certolizumab pegol in the treatment of inflammatory autoimmune diseases. Int J Mol Sci. 2017 Jan 23;18(1). [Internet]. [cited 2020 Sep 5]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297857/
   Web of Science ®Google Scholar
• Thomas SS, Borazan N, Barroso N, Duan L, Taroumian S, Kretzmann B, Bardales R, Elashoff D, Vangala S, Furst DE, et al. Comparative immunogenicity of TNF inhibitors: impact on clinical efficacy and tolerability in the management of autoimmune diseases. a systematic review and meta-analysis. BioDrugs. 2015 Aug 1;29(4):241–58. doi:10.1007/s40259-015-0134-5.
   PubMed Web of Science ®Google Scholar
• Fishwild DM, O’Donnell SL, Bengoechea T, Hudson DV, Harding F, Bernhard SL, Jones D, Kay RM, Higgins KM, Schramm SR, et al. High-avidity human IgG kappa monoclonal antibodies from a novel strain of minilocus transgenic mice. Nat Biotechnol. 1996 Jul;14(7):845–51. doi:10.1038/nbt0796-845.
   PubMed Web of Science ®Google Scholar
• Boyce EG, Halilovic J, Stan-Ugbene O. Golimumab: review of the efficacy and tolerability of a recently approved tumor necrosis factor-α inhibitor. Clin Ther. 2010 Sep;32(10):1681–703. doi:10.1016/j.clinthera.2010.09.003.
   PubMed Web of Science ®Google Scholar
• Gelfer G, Perry L, Deodhar A. Golimumab for the treatment of axial spondyloarthritis. Expert Rev Clin Immunol. 2016;12(1):9–18. doi:10.1586/1744666X.2016.1106941.
   PubMed Web of Science ®Google Scholar
• Martin PL, Cornacoff J, Prabhakar U, Lohr T, Treacy G, Sutherland JE, Hersey S, Martin E. Reviews preclinical safety and immune-modulating effects of therapeutic monoclonal antibodies to interleukin-6 and tumor necrosis factor-alpha in cynomolgus macaques. J Immunotoxicol. 2005 Jul 1;1(3):131–39. doi:10.1080/15476910490894904.
   PubMedGoogle Scholar
• Nelson AL, Dhimolea E, Reichert JM. Development trends for human monoclonal antibody therapeutics. Nat Rev Drug Discov. 2010 Oct;9(10):767–74. doi:10.1038/nrd3229.
   PubMed Web of Science ®Google Scholar
• Huffstutter JE, Kafka S, Brent LH, Matucci-Cerinic M, Tang KL, Chevrier M, Sprabery T, DeHoratius RJ. Clinical response to golimumab in rheumatoid arthritis patients who were receiving etanercept or adalimumab: results of a multicenter active treatment study. Curr Med Res Opin. 2017;33(4):657–66. doi:10.1080/03007995.2016.1277195.
   PubMed Web of Science ®Google Scholar
• Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, Nash P, Amante EJ, Churchill M, Park W, Pons-Estel BA, et al. Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum. 2009Aug;60(8): 2272–83.
   PubMed Web of Science ®Google Scholar
• Keystone EC, Genovese MC, Klareskog L, Hsia EC, Hall ST, Miranda PC, Pazdur J, Bae S-C, Palmer W, Zrubek J, et al. Golimumab, a human antibody to tumour necrosis factor given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis. 2009 Jun 1;68(6):789–96. doi:10.1136/ard.2008.099010.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Kay J, Doyle MK, Landewé R, Matteson EL, Wollenhaupt J, Gaylis N, Murphy FT, Neal JS, Zhou Y, 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 Lond Engl. 2009 Jul 18;374(9685):210–21. doi:10.1016/S0140-6736(09)60506-7.
   PubMed Web of Science ®Google Scholar
• Inman RD, Davis JC, van der Heijde D, Diekman L, Sieper J, Kim SI, Mack M, Han J, Visvanathan S, Xu Z, et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. Arthritis Rheum. 2008 Nov;58(11):3402–12. doi:10.1002/art.23969.
   PubMed Web of Science ®Google Scholar
• Kavanaugh A, McInnes I, Mease P, Krueger GG, Gladman D, Gomez-Reino J, Papp K, Zrubek J, Mudivarthy S, Mack M, et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum. 2009 Apr;60(4):976–86. doi:10.1002/art.24403.
   PubMed Web of Science ®Google Scholar
• Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Mack M, Goldstein N, Braun J, Kavanaugh A. Golimumab 3-year safety update: an analysis of pooled data from the long-term extensions of randomised, double-blind, placebo-controlled trials conducted in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis. Ann Rheum Dis. 2015 Mar 1;74(3):538–46. doi:10.1136/annrheumdis-2013-204195.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Feagan BG, Marano C. Achieving clinical response and remission in moderate-to-severe ulcerative colitis with golimumab. Gastroenterol Hepatol. 2014Jul;10(7): 452–54.
   Google Scholar
• Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel J, Reinisch W, et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan 1;146(1):96–109.e1. doi:10.1053/j.gastro.2013.06.010.
   PubMed Web of Science ®Google Scholar
• Simponi [Internet]. European medicines agency. 2018 [cited 2020 Jul 13]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/simponi
   Google Scholar
• Zhou H, Jang H, Fleischmann RM, Bouman-Thio E, Xu Z, Marini JC, Pendley C, Jiao Q, Shankar G, Marciniak SJ, et al. Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis. J Clin Pharmacol. 2007 Mar;47(3):383–96. doi:10.1177/0091270006298188.
   PubMed Web of Science ®Google Scholar
• Xu Z, Wang Q, Zhuang Y, Frederick B, Yan H, Bouman-Thio E, Marini JC, Keen M, Snead D, Davis HM, et al. Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects. J Clin Pharmacol. 2010 Mar;50(3):276–84. doi:10.1177/0091270009340782.
   PubMed Web of Science ®Google Scholar
• Clinical efficacy and safety: clinical pharmacology pharmacokinetics [Internet]. European Medicines Agency. 2018 [cited 2020 Jun 10]. Available from: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/clinical-efficacy-safety-clinical-pharmacology-pharmacokinetics
   Google Scholar
• Simsek I, Yazici Y. Safety and clinical efficacy of golimumab in the treatment of arthritides. Drug Healthc Patient Saf. 2010;2:169–80.
   PubMedGoogle Scholar
• Strand V, Balsa A, Al-Saleh J, Barile-Fabris L, Horiuchi T, Takeuchi T, Lula S, Hawes C, Kola B, Marshall L. et al. Immunogenicity of biologics in chronic inflammatory diseases: a systematic review. BioDrugs Clin Immunother Biopharm Gene Ther. 2017Aug;31(4): 299–316.
   Google Scholar
• Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Rheumatol Oxf Engl. 2019 01;58(3):441–46. doi:10.1093/rheumatology/key309.
   PubMed Web of Science ®Google Scholar
• Adedokun OJ, Gunn GR, Leu JH, Gargano C, Xu Z, Sandborn WJ, Rutgeerts P, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with ulcerative colitis. Inflamm Bowel Dis. 2019 20;25(9):1532–40. doi:10.1093/ibd/izz003.
   PubMed Web of Science ®Google Scholar
• Kavanaugh A, Husni ME, Harrison DD, Kim L, Lo KH, Leu JH, Hsia EC. Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: results through week twenty-four of the GO-VIBRANT study. Arthritis Rheumatol Hoboken NJ. 2017;69(11):2151–61. doi:10.1002/art.40226.
   PubMed Web of Science ®Google Scholar
• Rutgeerts P, Feagan BG, Marano CW, Padgett L, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Zhang H, Colombel J-F, et al. Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis. Aliment Pharmacol Ther. 2015 Sep;42(5):504–14. doi:10.1111/apt.13291.
   PubMed Web of Science ®Google Scholar
• Sieper J, van der Heijde D, Dougados M, Maksymowych WP, Scott BB, Boice JA, Berd Y, Bergman G, Curtis S, Tzontcheva A, et al. A randomized, double‐blind, placebo‐controlled, sixteen‐week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol Hoboken Nj. 2015 Oct;67(10):2702–12. doi:10.1002/art.39257.
   PubMed Web of Science ®Google Scholar
• Brunner HI, Ruperto N, Tzaribachev N, Horneff G, Chasnyk VG, Panaviene V, Abud-Mendoza C, Reiff A, Alexeeva E, Rubio-Pérez N, et al. Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial. Ann Rheum Dis. 2018 Jan;77(1):21–29. doi:10.1136/annrheumdis-2016-210456.
   PubMed Web of Science ®Google Scholar
• Dehoratius RJ, Brent LH, Curtis JR, Ellis LA, Tang KL. Satisfaction with subcutaneous golimumab and its auto-injector among rheumatoid arthritis patients with inadequate response to adalimumab or etanercept. Patient - Patient-Centered Outcomes Res. 2018 Jun;11(3):361–69.
   Web of Science ®Google Scholar
• Kavanaugh A, van der Heijde D, McInnes IB, Mease P, Krueger GG, Gladman DD, Gómez-Reino J, Papp K, Baratelle A, Xu W, et al. Golimumab in psoriatic arthritis: one-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial. Arthritis Rheum. 2012 Aug;64(8):2504–17. doi:10.1002/art.34436.
   PubMed Web of Science ®Google Scholar
• Kavanaugh A, McInnes IB, Mease P, Krueger GG, Gladman D, van der Heijde D, Zhou Y, Lu J, Leu JH, Goldstein N, et al. Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study). Ann Rheum Dis. 2014 Sep;73(9):1689–94. doi:10.1136/annrheumdis-2013-204902.
   PubMed Web of Science ®Google Scholar
• Vieira-Sousa E, Alves P, Rodrigues AM, Teixeira F, Tavares-Costa J, Bernardo A, Pimenta S, Pimentel-Santos FM, Gomes JL, Aguiar R, et al. GO-DACT: a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis. Ann Rheum Dis. 2020 Apr 1;79(4):490–98. doi:10.1136/annrheumdis-2019-216500.
   PubMed Web of Science ®Google Scholar
• Maxwell LJ, Zochling J, Boonen A, Singh JA, Veras MMS, Tanjong Ghogomu E, Jandu MB, Tugwell P, Wells GA. TNF-alpha inhibitors for ankylosing spondylitis. Cochrane Database Syst Rev. 2015 Apr 18;(4):CD005468.
   PubMed Web of Science ®Google Scholar
• Mok CC, Li OC, Chan KL, Ho LY, Hui PK. Effect of golimumab and pamidronate on clinical efficacy and MRI inflammation in axial spondyloarthritis: a 48-week open randomized trial. Scand J Rheumatol. 2015;44(6):480–86. doi:10.3109/03009742.2015.1038300.
   PubMed Web of Science ®Google Scholar
• Sepriano A, Regel A, van der Heijde D, Braun J, Baraliakos X, Landewé R, Van den Bosch F, Falzon L, Ramiro S. Efficacy and safety of biological and targeted-synthetic DMARDs: a systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis. RMD Open. 2017;3(1):e000396.
   PubMed Web of Science ®Google Scholar
• Dragoni G, Le Grazie M, Orlandini B, Rogai F. Golimumab in inflammatory bowel diseases: present and future scenarios. Clin J Gastroenterol. 2019 Feb;12(1):1–9. doi:10.1007/s12328-018-0906-9.
   PubMed Web of Science ®Google Scholar
• Hibi T, Imai Y, Senoo A, Ohta K, Ukyo Y. Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study). J Gastroenterol. 2017;52(10):1101–11. doi:10.1007/s00535-017-1326-1.
   PubMed Web of Science ®Google Scholar
• Detrez I, Dreesen E, Van Stappen T, de Vries A, Brouwers E, Van Assche G, Vermeire S, Ferrante M, Gils A. Variability in golimumab exposure: a ‘real-life’ observational study in active ulcerative colitis. J Crohns Colitis. 2016 May;10(5):575–81. doi:10.1093/ecco-jcc/jjv241.
   PubMed Web of Science ®Google Scholar
• Castro-Laria L, Argüelles-Arias F, García-Sánchez V, Benítez JM, Fernández-Pérez R, Trapero-Fernández AM, Gallardo-Sanchez F, Pallares-Manrique H, Gomez-Garcia M, Cabello-Tapia Mj, Talavera-Fabuel A. et al. Initial experience with golimumab in clinical practice for ulcerative colitis. Rev Espanola Enfermedades Dig Organo Of Soc Espanola Patol Dig. 2016Mar;108(3): 129–32.
   PubMed Web of Science ®Google Scholar
• Bosca-Watts MM, Cortes X, Iborra M, Huguet JM, Sempere L, Garcia G, Gil R, Garcia M, Muñoz M, Almela P, et al. Short-term effectiveness of golimumab for ulcerative colitis: observational multicenter study. World J Gastroenterol. 2016 Dec 21;22(47):10432–39. doi:10.3748/wjg.v22.i47.10432.
   PubMed Web of Science ®Google Scholar
• Tursi A, Allegretta L, Buccianti N, Della Valle N, Elisei W, Forti G, Faggiani R, Gallina S, Hadad Y, Larussa T, et al. Effectiveness and safety of golimumab in treating outpatient ulcerative colitis: a real-life prospective, multicentre, observational study in primary inflammatory bowel diseases centers. J Gastrointest Liver Dis JGLD. 2017 Sep;26(3):239–44. doi:10.15403/jgld.2014.1121.263.trs.
   PubMed Web of Science ®Google Scholar
• Taxonera C, Rodríguez C, Bertoletti F, Menchén L, Arribas J, Sierra M, Arias L, Martinez-Montiel P, Juan A, Iglesias E, Algaba A. Clinical outcomes of golimumab as first, second or third anti-tnf agent in patients with moderate-to-severe ulcerative colitis. Inflamm Bowel Dis. 2017;23(8):1394–402.
   PubMed Web of Science ®Google Scholar
• Palazzi C, D’angelo S, Gilio M, Leccese P, Padula A, Olivieri I. Golimumab for the treatment of axial spondyloarthritis. Expert Opin Biol Ther. 2017;17(1):129–33. doi:10.1080/14712598.2017.1256387.
   PubMed Web of Science ®Google Scholar
• Russi L, Scharl M, Rogler G, Biedermann L. The efficacy and safety of golimumab as third- or fourth-line anti-tnf therapy in patients with refractory crohn’s disease: a case series. Inflamm Intest Dis. 2017 Nov;2(2):131–38. doi:10.1159/000481400.
   PubMedGoogle Scholar
• Greener T, Boland K, Steinhart AH, Silverberg MS. The unfinished symphony: golimumab therapy for anti-tumour necrosis factor refractory Crohn’s Disease. J Crohns Colitis. 2018 Mar 28;12(4):458–64. doi:10.1093/ecco-jcc/jjx176.
   PubMed Web of Science ®Google Scholar
• Efficacy and safety of golimumab in Crohn’s disease: a French national retrospective study. Abstract - Europe PMC [Internet]. [cited 2020 Jun 20]. Available from: https://europepmc.org/article/med/29027693
   Google Scholar
• Palmou-Fontana N, Calvo-Río V, Martín-Varillas JL, Fernández-Díaz C, Mesquida M, Adán A, Hernandez MV, Cordero-Coma M, Alonso OM, Diaz-Valle D, Fernandez-Cid C. Golimumab in refractory uveitis associated to juvenile idiopathic arthritis: multicentre study of 7 cases and literature review. Clin Exp Rheumatol. 2018Aug;36(4): 652–57.
   PubMed Web of Science ®Google Scholar
• Tosi GM, Sota J, Vitale A, Rigante D, Emmi G, Lopalco G, Guerriero S, Orlando I, Iannone F, Frediani B, et al. Efficacy and safety of certolizumab pegol and golimumab in the treatment of non-infectious uveitis. Clin Exp Rheumatol. 2019Aug;37(4): 680–83.
   PubMed Web of Science ®Google Scholar
• Singh J, Noorbaloochi S, Singh G. Golimumab for rheumatoid arthritis: a systematic review. J Rheumatol. 2010 Jun 1;37(6):1096–104. doi:10.3899/jrheum.091466.
   PubMed Web of Science ®Google Scholar
• Hussar DA. New drugs: golimumab, besifloxacin hydrochloride, and artemether/lumefantrine. J Am Pharm Assoc JAPhA. 2009 Aug;49(4):570–74. doi:10.1331/JAPhA.2009.09523.
   PubMed Web of Science ®Google Scholar
• Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Zhou Y, Goldstein N, Braun J. Five-year safety data from 5 clinical trials of subcutaneous golimumab in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. J Rheumatol. 2016 Dec 1;43(12):2120–30.
   PubMed Web of Science ®Google Scholar
• Kim E-M, Uhm W-S, Bae S-C, Yoo D-H, Kim T-H. Incidence of tuberculosis among korean patients with ankylosing spondylitis who are taking tumor necrosis factor blockers. J Rheumatol. 2011 Oct;38(10):2218–23. doi:10.3899/jrheum.110373.
   PubMed Web of Science ®Google Scholar
• Wallis D, Thavaneswaran A, Haroon N, Ayearst R, Inman RD. Tumour necrosis factor inhibitor therapy and infection risk in axial spondyloarthritis: results from a longitudinal observational cohort. Rheumatol Oxf Engl. 2015 Jan;54(1):152–56. doi:10.1093/rheumatology/keu255.
   PubMed Web of Science ®Google Scholar
• Mohan VP, Scanga CA, Yu K, Scott HM, Tanaka KE, Tsang E, Tsai MC, Flynn JL, Chan J. Effects of tumor necrosis factor alpha on host immune response in chronic persistent tuberculosis: possible role for limiting pathology. Infect Immun. 2001 Mar;69(3):1847–55. doi:10.1128/IAI.69.3.1847-1855.2001.
   PubMed Web of Science ®Google Scholar
• Godfrey MS, Friedman LN. Tuberculosis and Biologic Therapies: anti-Tumor Necrosis Factor-α and Beyond. Clin Chest Med. 2019;40(4):721–39. doi:10.1016/j.ccm.2019.07.003.
   PubMed Web of Science ®Google Scholar
• Ai J-W, Zhang S, Ruan Q-L, Yu Y-Q, Zhang B-Y, Liu Q-H, Zhang W-H. The risk of tuberculosis in patients with rheumatoid arthritis treated with tumor necrosis factor-α antagonist: a metaanalysis of both randomized controlled trials and registry/cohort studies. J Rheumatol. 2015 Dec;42(12):2229–37. doi:10.3899/jrheum.150057.
   PubMed Web of Science ®Google Scholar
• Fonseca JE, Lucas H, Canhão H, Duarte R, Santos MJ, Villar M, Faustino A, Raymundo E. Recommendations for the diagnosis and treatment of latent and active tuberculosis in inflammatory joint diseases candidates for therapy with tumor necrosis factor alpha inhibitors: march 2008 update. Acta Reumatol Port. 2008Mar;33(1): 77–85.
   PubMed Web of Science ®Google Scholar
• Pham T, Bachelez H, Berthelot J-M, Blacher J, Bouhnik Y, Claudepierre P, Constantin A, Fautrel B, Gaudin P, Goëb V, et al. TNF alpha antagonist therapy and safety monitoring. Joint Bone Spine. 2011 May;78(Suppl 1):15–185. doi:10.1016/S1297-319X(11)70001-X.
   PubMed Web of Science ®Google Scholar
• Segaert S, Hermans C. Clinical signs, pathophysiology and management of cutaneous side effects of anti-tumor necrosis factor agents. Am J Clin Dermatol. 2017 Dec;18(6):771–87. doi:10.1007/s40257-017-0296-7.
   PubMed Web of Science ®Google Scholar
• LE Blay P, Mouterde G, Barnetche T, Morel J, Combe B. Short-term risk of total malignancy and nonmelanoma skin cancers with certolizumab and golimumab in patients with rheumatoid arthritis: metaanalysis of randomized controlled trials. J Rheumatol. 2012 Apr;39(4):712–15. doi:10.3899/jrheum.110982.
   PubMed Web of Science ®Google Scholar
• Michaud TL, Rho YH, Shamliyan T, Kuntz KM, Choi HK. The comparative safety of tumor necrosis factor inhibitors in rheumatoid arthritis: a meta-analysis update of 44 trials. Am J Med. 2014 Dec;127(12):1208–32.
   PubMed Web of Science ®Google Scholar
• Moulis G, Sommet A, Béné J, Montastruc F, Sailler L, Montastruc J-L, Lapeyre-Mestre M. Cancer risk of anti-TNF-α at recommended doses in adult rheumatoid arthritis: a meta-analysis with intention to treat and per protocol analyses. PloS One. 2012;7(11):e48991. doi:10.1371/journal.pone.0048991.
   PubMed Web of Science ®Google Scholar
• Lemaitre M, Kirchgesner J, Rudnichi A, Carrat F, Zureik M, Carbonnel F, Dray-Spira R. Association between use of thiopurines or tumor necrosis factor antagonists alone or in combination and risk of lymphoma in patients with inflammatory bowel disease. JAMA. 2017 Nov 7;318(17):1679–86. doi:10.1001/jama.2017.16071.
   PubMed Web of Science ®Google Scholar
• Osterman MT, Sandborn WJ, Colombel J-F, Robinson AM, Lau W, Huang B, Pollack PF, Thakkar RB, Lewis JD. Increased risk of malignancy with adalimumab combination therapy, compared with monotherapy, for crohn’s disease. Gastroenterology. 2014 Apr 1;146(4):941–949.e2.
   PubMed Web of Science ®Google Scholar
• Lichtenstein GR, Feagan BG, Cohen RD, Salzberg BA, Diamond RH, Langholff W, Londhe A, Sandborn WJ. Drug therapies and the risk of malignancy in Crohn’s disease: results from the TREATTM Registry. Am J Gastroenterol. 2014 Feb;109(2):212–23. doi:10.1038/ajg.2013.441.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ. State-of-the-art: immunosuppression and biologic therapy. Dig Dis Basel Switz. 2010;28(3):536–42. doi:10.1159/000320413.
   PubMed Web of Science ®Google Scholar
• Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D’Haens G, Diamond RH, Broussard DL, et al. Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Engl J Med. 2010 Apr 15;362(15):1383–95. doi:10.1056/NEJMoa0904492.
   PubMed Web of Science ®Google Scholar
• Dulai PS, Siegel CA. The risk of malignancy associated with the use of biological agents in patients with inflammatory bowel disease. Gastroenterol Clin North Am. 2014 Sep;43(3):525–41. doi:10.1016/j.gtc.2014.05.010.
   PubMed Web of Science ®Google Scholar
• Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006 May 17;295(19):2275–85.
   PubMed Web of Science ®Google Scholar
• Askling J, Fahrbach K, Nordstrom B, Ross S, Schmid CH, Symmons D. Cancer risk with tumor necrosis factor alpha (TNF) inhibitors: meta-analysis of randomized controlled trials of adalimumab, etanercept, and infliximab using patient level data. Pharmacoepidemiol Drug Saf. 2011 Feb;20(2):119–30. doi:10.1002/pds.2046.
   PubMed Web of Science ®Google Scholar
• Zidi I, Bouaziz A, Mnif W, Bartegi A, Ben Amor N. Golimumab and malignancies: true or false association? Med Oncol Northwood Lond Engl. 2011 Jun;28(2):641–48. doi:10.1007/s12032-010-9490-7.
   PubMed Web of Science ®Google Scholar
• Hassid B, Mahadevan U. The use of biologic therapy in pregnancy: a gastroenterologist’s perspective. Curr Opin Rheumatol. 2014 May;26(3):347–53. doi:10.1097/BOR.0000000000000048.
   PubMed Web of Science ®Google Scholar
• Bröms G, Granath F, Ekbom A, Hellgren K, Pedersen L, Sørensen HT, Stephansson O, Kieler H. Low risk of birth defects for infants whose mothers are treated with anti-tumor necrosis factor agents during pregnancy. Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc. 2016Feb;14(2): 234–241.e1–5.
   Google Scholar
• Weber-Schoendorfer C, Oppermann M, Wacker E, Bernard N, Beghin D, Cuppers-Maarschalkerweerd B, Richardson JL, Rothuizen LE, Pistelli A, Malm H, et al. network of French pharmacovigilance centres, Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study. Br J Clin Pharmacol. 2015 Oct;80(4):727–39. doi:10.1111/bcp.12642.
   PubMed Web of Science ®Google Scholar
• Johansen CB, Jimenez-Solem E, Haerskjold A, Sand FL, Thomsen SF. The use and safety of TNF inhibitors during pregnancy in women with psoriasis: a review. Int J Mol Sci. 2018 May 3;19(5):1349. [Internet]. [cited 2020 Jul 12]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5983707/
   PubMed Web of Science ®Google Scholar
• Ben-Horin S, Yavzori M, Kopylov U, Picard O, Fudim E, Eliakim R, Chowers Y, Lang A. Detection of infliximab in breast milk of nursing mothers with inflammatory bowel disease. J Crohns Colitis. 2011 Dec;5(6):555–58. doi:10.1016/j.crohns.2011.05.006.
   PubMed Web of Science ®Google Scholar
• Hyams JS, Chan D, Adedokun OJ, Padgett L, Turner D, Griffiths A, Veereman G, Heyman MB, Rosh JR, Wahbeh G, et al. Subcutaneous Golimumab in Pediatric Ulcerative Colitis: pharmacokinetics and Clinical Benefit. Inflamm Bowel Dis. 2017;23(12):2227–37. doi:10.1097/MIB.0000000000001262.
   PubMed Web of Science ®Google Scholar