ADERSON OMAR MOURAO CINTRA DAMIAO

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Lattes
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Instituto Central, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/07 - Laboratório de Gastroenterologia Clínica e Experimental, Hospital das Clínicas, Faculdade de Medicina

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  • article 66 Citação(ões) na Scopus
    Safety and efficacy of tofacitinib for treatment of ulcerative colitis: final analysis of OCTAVE Open, an open-label, long-term extension study with up to 7.0 years of treatment
    (2022) SANDBORN, William J.; LAWENDY, Nervin; DANESE, Silvio; SU, Chinyu; LOFTUS JR., Edward V.; HART, Ailsa; DOTAN, Iris; DAMIAO, Aderson O. M. C.; JUDD, Donna T.; GUO, Xiang; MODESTO, Irene; WANG, Wenjin; PANES, Julian
    Background Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. We present final data from OCTAVE Open, an open-label, long-term extension study. Aims The primary objective of OCTAVE Open was to assess the safety and tolerability of long-term tofacitinib in patients with ulcerative colitis; evaluating efficacy was a secondary objective. Methods Eligible patients included OCTAVE Induction 1&2 non-responders and OCTAVE Sustain completers/treatment failures. Patients in remission at OCTAVE Open baseline received tofacitinib 5 mg b.d.; all others received 10 mg b.d. Incidence rates (unique patients with events/100 patient-years) for adverse events of special interest were calculated; <= 7.0 years of observation. Efficacy endpoints derived from Mayo score were reported <= 36 months (last scheduled endoscopy visit). Results In OCTAVE Open, 769 of 944 patients (81.5%) initially received tofacitinib 10 mg b.d. Among all patients (2440.8 patient-years of exposure), incidence rates (IRs; 95% confidence intervals) for deaths and adverse events of special interest were: deaths, 0.25 (0.09-0.54); serious infections, 1.61 (1.14-2.20); herpes zoster (non-serious and serious), 3.16 (2.47-3.97); opportunistic infections, 0.87 (0.54-1.33); major adverse cardiovascular events, 0.16 (0.04-0.42); malignancies (excluding non-melanoma skin cancer), 1.03 (0.67-1.52); non-melanoma skin cancer, 0.75 (0.45-1.19); deep vein thrombosis, 0.04 (0.00-0.23); pulmonary embolism, 0.21 (0.07-0.48). At Month 36, 66.9% and 40.3% showed clinical response, 64.6% and 37.1% had endoscopic improvement, and 58.9% and 33.7% maintained or achieved remission, with tofacitinib 5 and 10 mg b.d. respectively. Conclusion Tofacitinib demonstrated consistent safety up to 7.0 years. Data collected up to Month 36 support long-term efficacy beyond the 52-week maintenance study.
  • conferenceObject
    The effect of tofacitinib on serum lipids and cardiovascular safety in patients with ulcerative colitis: updated results from the tofacitinib ulcerative colitis clinical programme
    (2020) SANDS, B. E.; TAUB, P. R.; FEAGAN, B. G.; ARMUZZI, A.; DAMIAO, A. O.; LAWENDY, N.; SOLANO, G.; KWOK, K.; WOOLCOTT, J.; SALESE, L.; SU, C.
  • article 11 Citação(ões) na Scopus
    New insights on the surgical management of ulcerative colitis in the 21st century
    (2022) KOTZE, Paulo G.; HEUTHORST, Lianne; LIGHTNER, Amy L.; DAMIAO, Aderson O. M. C.; BEMELMAN, Willem A.
    Despite substantial advances in medical therapy since 2005 that have led to the approval and increased use of novel biological agents and small molecules, colectomy is still a therapeutic option for some patients with ulcerative colitis. In the biological era (ie, after the approval of biological agents for ulcerative colitis), improved control of disease activity has led to a trend of decreasing colectomy rates for refractory disease. Consequently, indications for colectomy for dysplasia and colorectal cancer seem to be increasing. Advances have not only been made in surgical techniques, but also in multidisciplinary approaches, the timing of surgery, and in medical management before and after surgery. This Review discusses surgical indications in patients with ulcerative colitis in relation to current medical therapy, management in the acute setting, indications for staged procedures, new techniques such as transanal surgery and robotics, and surgical alternatives to ileal pouch-anal anastomosis. A multidisciplinary approach including surgeons, gastroenterologists, pathologists, radiologists, and clinical nutritionists is essential to improving patient outcomes in different clinical scenarios of ulcerative colitis management in the 21st century.