The safety of ustekinumab for the treatment of psoriatic arthritis

Abstract

The cytokines interleukin (IL)-12 and IL-23 have been involved in the pathogenesis of psoriasis and psoriatic arthritis. Ustekinumab is a fully human monoclonal antibody targeting the p40 subunit shared by IL-12 and IL-23. Ustekinumab prevents the interaction of IL-12 and IL-23 binding to their receptors, blocking the T1 and T17 inflammatory pathways. Ustekinumab has been evaluated for the treatment of various chronic immune mediated diseases including psoriasis and psoriatic arthritis (PsA). Most of the data regarding the safety of ustekinumab come from the experience treating patients with psoriasis, but clinical trials have demonstrated its efficacy and safety in the treatment of both diseases. The most common adverse events observed during the clinical trials are mild in intensity, and include respiratory tract infections, nasopharyngitis, headache and injection site reactions. Throughout long-term ustekinumab treatment, serious infections or major cardiovascular adverse events occurred rarely. Areas covered: In this review we report the safety data that come from phase II and phase III clinical trials that assay the efficacy and safety of ustekinumab in PsA, including recently published data corresponding to long-term studies. Relevant references were obtained through a literature search in MEDLINE/Pubmed (search strategy: ustekinumab AND psoriatic arthritis) for articles published until November 2016, complemented by a manual search. Expert opinion: In clinical practice, ustekinumab is generally a well-tolerated treatment, and the safety profile in psoriatic arthritis is similar to that reported in plaque psoriasis.

Effectiveness and safety of ustekinumab induction therapy for 103 patients with ulcerative colitis: a GETAID multicentre real‐world cohort study

“…The safety of ustekinumab in patients with chronic immune-mediated inflammatory diseases (IMIDs) has been extensively evaluated in numerous clinical trials and in post-marketing observational studies included in controlled trials. [19][20][21] In the UNITI trial, the incidence of serious adverse event with ustekinumab was similar to that with placebo.…”

Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn’s disease

“…The ideal approach to selecting dual biologic regimens remains to be determined. Vedolizumab or ustekinumab may be ideal adjunct therapies in DBT regimens due to their favourable safety profile 12,13,21,22 . For this reason, most patients in our study received vedolizumab, and the most frequently used pairing was with ustekinumab.…”

“…We hypothesise that vedolizumab may be an optimal therapeutic anchor to dual biologic therapy due to its favourable safety profile, which is attributed to its gut‐specific mechanism. For similar safety considerations, ustekinumab may be a reasonable alternative anchor 12,13,21,22 . We report the largest cohort to date on the preliminary evidence of efficacy and tolerability of DBT in a high‐risk group of patients with refractory Crohn's disease.…”

Singapore chapter of rheumatologists' updated consensus statement on the eligibility for government subsidization of biologic and targeted therapy for the treatment of psoriatic arthritis

“…Other guidelines published between 2011 and 2018 tend to favor TNFi as first‐choice biologic (Table ), primarily due to longer experience with this class and their established safety. However, we decided to include all the approved drug classes, as no unusual safety signals have emerged thus far and clinicians have increasing experience with their use …”

“…However, we decided to include all the approved drug classes, as no unusual safety signals have emerged thus far and clinicians have increasing experience with their use. 14,15,[45][46][47][48][49][50]…”