Long‐term safety of adalimumab in clinical trials in adult patients with Crohn's disease or ulcerative colitis

Abstract

Patients with moderately to severely active Crohn's disease or ulcerative colitis continued to experience acceptable safety with adalimumab, without new safety signals.

Systematic review and network meta‐analysis: first‐ and second‐line biologic therapies for moderate‐severe Crohn's disease

“…However, using trials of maintenance therapy to assess safety of therapies may be biased, due to selective inclusion of patients who have demonstrated tolerability in the induction phases. Long‐term registry studies and real‐world observational cohorts suggest an increase in risk of serious infections, and a marginal increase in the risk of lymphoma with anti‐TNF agents, particularly when combined with immunomodulators . While long‐term safety data on ustekinumab in patients with Crohn's disease is awaited, registry studies in patients with psoriasis suggest an increase in risk of serious infections, but not malignancy or cardiovascular events in ustekinumab‐treated patients .…”

Patient sex does not affect endoscopic outcomes of biologicals in inflammatory bowel disease but is associated with adverse events

“…In total, 14 studies were included, assessing 17,680 patients treated with biologicals [9, 16, 21-23, 28, 32-35, 47, 49, 60, 62]. Ten studies were retrospective [9, 21, 28, 33-35, 47, 49, 60, 62], one was prospective [16] and the remaining 3 were post hoc analyses of RCTs [22,23,32] ( Table 2). The quality of the different studies was poor, with a median NOS of 5 (range 5-8).…”

“…In total, 12 studies consisted of cohorts concerning a single biological [16, 21-23, 28, 32-35, 47, 49, 60]. Two studies involved adalimumab [23,47], eight involved infliximab [16, 21, 28, 33-35, 49, 60] and two assessed vedolizumab [22,32]. Of the adalimumab studies, one consisted of a cohort of CD patients [47] and the other of a cohort of IBD patients [23].…”

“…Two studies involved adalimumab [23,47], eight involved infliximab [16, 21, 28, 33-35, 49, 60] and two assessed vedolizumab [22,32]. Of the adalimumab studies, one consisted of a cohort of CD patients [47] and the other of a cohort of IBD patients [23]. For infliximab, seven studies were retrospective cohorts [21, 28, 33-35, 49, 60] and one was prospective [16].…”

Escalating dose of adalimumab as monotherapy to treat unusual giant and refractory oral‐pharyngeal ulcerations in Crohn's disease

“…ADM has been demonstrated to be efficacious in the induction and maintenance of remission and response in CD (Chalhoub, Rimmani, Gumaste, & Sharara, ) and is well tolerated in patients with moderately to severely active CD, with no new safety concerns or associations with mortality (Colombel et al, ). More recently, it has been evidenced that ADM is also capable of inducing early and sustained mucosal healing in many patients with moderate to severe ileocolic CD (Rutgeerts et al, ).…”