Effects of Filgotinib on Semen Parameters and Sex Hormones in Male Patients with Inflammatory Diseases: Results from the Phase 2, Randomised, Double-blind, Placebo-controlled MANTA and MANTA-RAy Studies
Ann Rheum Dis 2023;82:1049–1058
Reinisch, et al. show that filgotinib treatment has no effect on semen parameters for men with active inflammatory diseases. This contrasts with pre-clinical studies that showed fertility issues in male animals.
N Engl J Med. 2021;384(13):1227-1239.Upadacitinib efficacy proves to be greater than placebo, and non-inferior to adalimumab, in treating patients with psoriatic arthritis (PsA). Already approved for the treatment of rheumatoid arthritis, McInnes, et al. studied oral upadacitinib at a dose of 15 mg or 30 mg, alongside placebo or adalimumab, in this 24-week, Phase III trial, in over 1700 patients with PsA. At the primary endpoint (Week 12), ACR20 response was greater with upadacitinib than placebo, and non-inferior to adalimumab; wi...
Fenebrutinib Versus Placebo or Adalimumab in Rheumatoid Arthritis: A Randomized, Double-Blind, Phase II Trial (ANDES Study)
Arthritis Rheumatol. 2020 Sep; 72(9): 1435–1446.In this randomised phase II trial with MTX treatment-refractory RA patients, greater efficacy was observed with fenebrutinib 150 mg once daily or 200 mg twice daily compared to placebo, while response rates were numerically similar to those observed with adalimumab. BTK inhibitors have demonstrated clinical efficacy in B cell malignancies and multiple sclerosis, although there is limited clinical evidence of its efficacy in RA. Fenebrutinib (FEN) an orally active and selective non-covalent inhib...