Inflammatory bowel diseases
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Inflamm. Bowel Dis. · Sep 2018
Randomized Controlled Trial Multicenter StudyHerpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib.
Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). Tofacitinib is approved for rheumatoid arthritis and psoriatic arthritis, where it has been shown to increase herpes zoster (HZ) risk. We evaluated HZ risk among UC patients using tofacitinib. ⋯ In tofacitinib-treated UC patients, there was an elevated risk of HZ, although complicated HZ was infrequent. Increased HZ rates occurred in patients who were older, Asian, or had prior TNFi failure (NCT00787202, NCT01465763, NCT01458951, NCT01458574, NCT01470612).
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Inflamm. Bowel Dis. · Oct 2015
Randomized Controlled Trial Multicenter StudySafety and Efficacy of an Oral Inhibitor of the Purinergic Receptor P2X7 in Adult Patients with Moderately to Severely Active Crohn's Disease: A Randomized Placebo-controlled, Double-blind, Phase IIa Study.
AZD9056 is a selective orally active inhibitor of the purinergic receptor P2X7, which is a key player in the generation and secretion of several proinflammatory cytokines involved in the pathogenesis of Crohn's disease (CD). The aim of this phase IIa study was to assess the efficacy and safety of AZD9056 for the treatment of moderately to severely active CD. ⋯ Our data suggest that the purinergic receptor P2X7 antagonist AZD9056 has the potential to improve symptoms in patients with moderate-to-severe CD combined with a beneficial risk profile. Although the lack in change of inflammatory biomarkers questions its anti-inflammatory potential, the results obtained in this study rather suggest P2X7 antagonism for the treatment of chronic abdominal pain.
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Inflamm. Bowel Dis. · Jul 2013
Randomized Controlled Trial Multicenter Study Comparative Study52-week efficacy of adalimumab in patients with moderately to severely active ulcerative colitis who failed corticosteroids and/or immunosuppressants.
The results of an open-label follow-up until week 52 of patients with moderately to severely active ulcerative colitis who participated in a double-blind placebo-controlled adalimumab induction trial (ULTRA 1, NCT00385736) are reported. ⋯ In this open-label study, adalimumab was effective for maintaining clinical remission in anti-tumor necrosis factor-naive patients with moderately to severely active ulcerative colitis who did not adequately respond to conventional therapy.
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Inflamm. Bowel Dis. · Jul 2013
Randomized Controlled Trial Multicenter StudyIron deficiency generates secondary thrombocytosis and platelet activation in IBD: the randomized, controlled thromboVIT trial.
Secondary thrombocytosis is a common clinical feature. In patients with cancer, it is a risk factor for venous thromboembolic events. In inflammatory bowel disease (IBD), thrombocytosis is so far considered a marker of active disease and may contribute to the increased thromboembolic risk in this population. Observed effects of iron therapy on normalization of platelet counts led us to hypothesize that iron itself may regulate megakaryopoiesis. Here, we want to test the effect of iron replacement on platelet count and activity in IBD-associated thrombocytosis. ⋯ FCM lowers platelet counts and platelet activation in patients with IBD-associated secondary thrombocytosis.
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Inflamm. Bowel Dis. · Jul 2010
Randomized Controlled Trial Multicenter StudyRandomized, double-blind, placebo-controlled trial of the oral interleukin-12/23 inhibitor apilimod mesylate for treatment of active Crohn's disease.
Interleukin-12 (IL-12) and interleukin-23 (IL-23) are inflammatory cytokines linked to the Th-1 and Th-17 phenotypes associated with Crohn's disease (CD). We investigated the activity and safety of apilimod mesylate (formerly STA-5326), an oral IL-12 and IL-23 inhibitor, in patients with active CD. ⋯ Apilimod was well-tolerated but did not demonstrate efficacy over placebo in patients with active CD.