New anti-inflammatory drugs! Long-term expansion of Johnson and Johnson Stelara's treatment of Crohn's disease (CD): 5 years of treatment to maintain high efficacy!

Oct 13, 2020 // -- Johnson and Johnson (JNJ) recently announced the latest, final five-year data from the 28th European Digestive Disease Week (UEG Week 2020) virtual conference on the anti-inflammatory drug Stelara (Chinese commodity name: Starano, generic name: ustekinumab, Usnu single anti-injection) Phase 3 IM-UNITI Open Label Extension (LTE).
results show that Stelara treatment can sustain long-term remission for up to 5 years in patients with moderate to severe Crohn's disease (CD).
IM-UNII was a multi-center, randomized, double-blind, placebo-controlled, parallel group 3 study that evaluated the efficacy and safety of Stelara maintenance therapy in adult patients with moderate to severe CD.
in UNITI-1 or UNITI-2 induction studies, patients who responded to a single intravenous Stelara were randomly assigned subsethic injection (SC) Stelara 90mg every 8 weeks (Q8W), every 12 weeks (Q12W), and placebo.
1281 patients were included in the maintenance study.
randomized patients who met the criteria for loss of reaction during the 8-32 weeks, a one-time dose adjustment to 90 mg Q8W occurred.
patients who have completed 44 weeks are eligible for LTE and continue their current treatment until week 252.
Key results showed that in LTE studies, more than half of patients who were randomly assigned to receive SC Stelara Q8W and continued to receive this dose in LTE studies maintained clinical response (57 percent) and clinical remission (55 percent) over a five-year period of treatment.
93% of these patients in clinical remission did not use steroids(steroid-free).
subgroup analysis table, 59% of patients in subgroups that had never received anti-tumor necrosis group α (TNF-α) biologics received SC Stelara Q8W maintenance treatment for five years, and 59% of patients were in clinical remission.
addition, 44% of patients in subgroups that failed or were insatiable with TNF-α were treated with SC Stelara Q8W maintenance for five years, with 44% of patients in clinical remission.
of all patients (randomized and assigned) who were included in the LTE study completed their final drug visits (51 per cent, s290/567).
During the five-year treatment period, the adverse events (AEs), severe adverse events (SAEs), and serious infections in the Q8W Stelara group were significantly the same as among the placebo group.
to week 272, the rate of antistelara antibodies remained low, with a 5% rate in patients who were assigned to receive Stelara in the maintenance study and continued to receive the approved 90mg SC Q8W program in LTE.
no new safety signals have been observed.
Dr William J. Sandbornii, a professor of medicine and director of gastroenterology at the University of California, San Diego and the lead researcher on the study, said: "Crohn's disease (CD) is one of the most debilitating inflammatory bowel diseases, disrupting the lives of millions of patients around the world.
im-UNITI study showed that patients were able to achieve treatment through Stelara maintenance for up to five years.
note that for those with clinical remission, the majority (more than 90%) of patients treated with Q8W Stelara did not use steroids for 5 years.
"Selara is the world's first biological agent to selectively target both IL-12 and IL-23.
IL-12 and IL-23 are two naturally occurring cytokines that are thought to play a key role in immuno-mediated inflammatory diseases, including UC, plaque-type psoriasis, psoriasis arthritis, Crohn's disease, and so on.
Stelara inhibits these two pre-inflammatory cytokines by binding to the p40 sub-base common to IL-12 and IL-23, preventing it from binding to the cell surface subject, IL-12 beta1.
Stelara was launched in September 2009 and has now been approved for treatment of: (1) adolescents with moderate to severe plaque psoriasis (≥6 years of age) and adult patients;
in China, Stelara ®, a biologic that is injected subsulticly every three months for a maintenance period, was launched in June 2019 Treatment of patients with moderate to severe plaque-like psoriasis in adults who should not be answered, taboo or insufferable for other systems such as cyclosporine, methotrexate (MTX) or PUVA (osteolipids and ultraviolet A).
is a core product of Johnson and Johnson's foray into autoimmune diseases, with sales of $6.361 billion in 2019.
January, an article in the top international journal Nature noted that Stelara's sales are expected to reach $7,241 million in 2020, ranking seventh among the world's best-selling TOP10 drugs in 2020, as adaptations continue to grow, the market expands and permeates.
() Origin: STELARA? (ustekinumab) Five-Year Results Presented from Long-term Study of Clinical Response and Remision in Patients with Moderate to Severe Crohn's Disease.