The MARCOPOLO Study of Ustekinumab Utilization and Efficacy in a Real-World Setting: Treatment of Patients with Plaque Psoriasis in Asia-Pacific Countries

Abstract

BackgroundUstekinumab is a fully human monoclonal antibody approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults. However, factors including efficacy, tolerability, ease of use, and cost burden may affect ustekinumab utilization. Noncompliance may, in turn, affect treatment response.ObjectiveTo evaluate ustekinumab utilization in the real-world setting in Asia-Pacific countries.MethodsIn this phase 4 observational study conducted in Indonesia, Malaysia, Singapore, Korea, and Taiwan, adults with plaque psoriasis receiving ustekinumab were followed for up to 52 weeks. Study endpoints were the proportion of all patients using ustekinumab according to label-recommended intervals and the proportion of Korean patients who achieved a psoriasis area severity index 75 response at week 16. Safety was assessed by monitoring adverse events.ResultsOverall, 169 patients received ustekinumab (Korea, n=102; other countries, n=67). Just over half (56.2%) of patients used ustekinumab with the label-recommended interval from baseline to week 40; the proportion was higher in Korea (73.5%) than in other countries (29.9%), probably because ustekinumab was provided without charge for Korean patients up to week 40. Noncompliance increased after week 40 in Korea and from week 28 in other Asia-Pacific countries, with cost cited as the most common reason. At week 16, 56.9% of Korean patients achieved a Psoriasis Area Severity Index 75 response. Safety results were in line with those seen in previous studies.ConclusionMore than half of all patients in Asia-Pacific countries used ustekinumab as per the label-recommended dose interval, but reimbursement variations between countries may have confounded overall results.

Consistent responses with guselkumab treatment in Asian and non‐Asian patients with psoriasis: An analysis from VOYAGE 1 and VOYAGE 2

“…In contrast, early studies of anti-TNF biologics in Asian populations produced variable efficacy results, possibly due to small sample size. 29 More recent studies with agents targeting IL-12/23, IL-23, or IL-17 have demonstrated efficacy results in Asian patients that are generally comparable with those reported in non-Asian patients, 4,[13][14][15][16][17][18][19] as demonstrated in this post-hoc analysis.…”

“…Studies of anti‐tumor necrosis factor (TNF) agents in Asian patients have been reported, but many of these studies are smaller and later in the development cycle of the agent than studies in populations of mixed race . Substantial numbers of Asian patients were included in the pivotal studies of agents targeting interleukin (IL)‐12/23, IL‐23, and IL‐17, allowing for subanalyses of the Asian populations in these studies . Separate studies of these agents have also been conducted specifically in Asian countries …”

“…[10][11][12] Substantial numbers of Asian patients were included in the pivotal studies of agents targeting interleukin (IL)-12/23, IL-23, and IL-17, allowing for subanalyses of the Asian populations in these studies. [13][14][15][16] Separate studies of these agents have also been conducted specifically in Asian countries. 4,[17][18][19] Guselkumab (TREMFYA â ; Janssen Research & Development, LLC, Spring House, PA, USA) is a fully human immunoglobulin G1 lambda monoclonal antibody that inhibits IL-23-mediated intracellular and downstream signaling by binding to the IL-23 p19 protein subunit with high specificity and affinity.…”

Effectiveness End Points in Real-World Studies on Biological Therapies in Psoriasis: Systematic Review with Focus on Drug Survival

“…Clinical outcomes (mainly PASI) were reported in 75% of prospective studies [27, 39, 47-53], in about 50% of prospective registries [20, 24, 54-61] and retrospective studies [29, 30, 32, 34, 37, 62-70], and in no retrospective administrative databases/claims. Drug survival of biological therapies was reported in over 60% of prospective registries [14, 20, 21, 24, 25, 31, 54, 57, 71-74], retrospective studies [18, 19, 22, 23, 26, 29, 30, 32, 34, 37, 38, 68, 70, 75-77] and administrative databases/claims [28, 35, 36, 40-42, 46], and less frequently (33%) in prospective studies [27, 33, 52, 78].…”

“…The percentage of patients who discontinued biological therapies within the end of the follow-up period was reported in 90% of retrospective administrative databases/claims [28, 35, 36, 40-45] and in about 60% of other study designs. Compliance with biological therapies was rarely considered in these effectiveness studies [15, 43, 45, 53]. …”