A phase 2a, randomized, double-blind, placebo-controlled trial of the efficacy and safety of the oral gonadotropin-releasing hormone antagonist, ASP1707, in postmenopausal female patients with rheumatoid arthritis taking methotrexate

References

• Bortoluzzi A, Furini F, Generali E, Silvagni E, Luciano N, Scirè CA, et al. One year in review 2018: novelties in the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2018;36(3):347–61.
   PubMed Web of Science ®Google Scholar
• Guo Q, Wang Y, Xu D, Nossent J, Pavlos NJ, Xu J, et al. Rheumatoid arthritis: pathological mechanisms and modern pharmacologic therapies. Bone Res. 2018;6(1):15.
   PubMed Web of Science ®Google Scholar
• Cross M, Smith E, Hoy D, Carmona L, Wolfe F, Vos T, et al. The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73(7):1316–22.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Landewé 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.
   PubMed Web of Science ®Google Scholar
• Thakur S, Riyaz B, Patil A, Kaur A, Kapoor B, Mishra V, et al. Novel drug delivery systems for NSAIDs in management of rheumatoid arthritis: an overview. Biomed Pharmacother. 2018;106:1011–23.
   PubMed Web of Science ®Google Scholar
• Kanik KS, Wilder RL. Hormonal alterations in rheumatoid arthritis, including the effects of pregnancy. Rheum Dis Clin North Am. 2000;26(4):805–23.
   PubMed Web of Science ®Google Scholar
• Chen A, Ganor Y, Rahimipour S, Ben-Aroya N, Koch Y, Levite M, et al. The neuropeptides GnRH-II and GnRH-I are produced by human T cells and trigger laminin receptor gene expression, adhesion, chemotaxis and homing to specific organs. Nat Med. 2002;8(12):1421–6.
   PubMed Web of Science ®Google Scholar
• Iqbal J, Sun L, Kumar TR, Blair HC, Zaidi M. Follicle-stimulating hormone stimulates TNF production from immune cells to enhance osteoblast and osteoclast formation. Proc Natl Acad Sci U S A. 2006;103(40):14925–30.
   PubMed Web of Science ®Google Scholar
• Sabharwal P, Varma S, Malarkey WB. Human thymocytes secrete luteinizing hormone: an autocrine regulator of T-cell proliferation. Biochem Biophys Res Commun. 1992;187(2):1187–92.
   PubMed Web of Science ®Google Scholar
• Ansari MA, Dhar M, Spieker S, Bakht N, Rahman AM, Moore WV, et al. Modulation of diabetes with gonadotropin-releasing hormone antagonists in the nonobese mouse model of autoimmune diabetes. Endocrinology. 2004;145(1):337–42.
   PubMed Web of Science ®Google Scholar
• Kass AS, Forre OT, Fagerland MW, Gulseth HC, Torjesen PA, Hollan I, et al. Short-term treatment with a gonadotropin-releasing hormone antagonist, cetrorelix, in rheumatoid arthritis (AGRA): a randomized, double-blind, placebo-controlled study. Scand J Rheumatol. 2014;43(1):22–7.
   PubMed Web of Science ®Google Scholar
• 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(6):727–35.
   PubMed Web of Science ®Google Scholar
• Fransen J, Welsing PMJ, De Keijzer RMH, Van Riel PLCM. Disease activity scores using C-reactive protein: CRP may replace ESR in the assessment of RA disease activity. Ann Rheum Dis. 2004;62(Suppl 1):151.
   Google Scholar
• Matsuda Y, Singh G, Yamanaka H, Tanaka E, Urano W, Taniguchi A, et al. Validation of a Japanese version of the Stanford Health Assessment Questionnaire in 3,763 patients with rheumatoid arthritis. Arthritis Rheum. 2003;49(6):784–8.
   PubMed Web of Science ®Google Scholar
• 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(1):34–40.
   PubMed Web of Science ®Google Scholar
• Tanaka Y, Emoto K, Cai Z, Aoki T, Schlichting D, Rooney T, et al. Efficacy and safety of baricitinib in Japanese patients with active rheumatoid arthritis receiving background methotrexate therapy: a 12-week, double-blind, randomized placebo-controlled study. J Rheumatol. 2016;43(3):504–11.
   PubMed Web of Science ®Google Scholar
• Tanaka Y, Harigai M, Takeuchi T, Yamanaka H, Ishiguro N, Yamamoto K, et al. Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study. Ann Rheum Dis. 2012;71(6):817–24.
   PubMed Web of Science ®Google Scholar
• Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, et al. Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial. Modern Rheumatology. 2014;24(5):715–24.
   PubMed Web of Science ®Google Scholar
• Xeljanz (tofacitinib) [package insert]. Japan: Pfizer Inc; 2019.
   Google Scholar
• Zhu D, Li X, Macrae VE, Simoncini T, Fu X. Extragonadal effects of follicle-stimulating hormone on osteoporosis and cardiovascular disease in women during menopausal transition. Trends Endocrinol Metab. 2018;29(8):571–80.
   PubMed Web of Science ®Google Scholar
• Prior JC. Perimenopause: the complex endocrinology of the menopausal transition. Endocr Rev. 1998;19(4):397–428.
   PubMed Web of Science ®Google Scholar
• Kass A, Hollan I, Fagerland MW, Gulseth HC, Torjesen PA, Forre OT. Rapid anti-inflammatory effects of gonadotropin-releasing hormone antagonism in rheumatoid arthritis patients with high gonadotropin levels in the AGRA trial. PLoS One. 2015;10(10):e0139439.
   PubMed Web of Science ®Google Scholar