Three-year extended phase data of Johnson & Johnson's Starnox study: showing sustained symptom relief

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced the anti-inflammatory drug Stelara (Chinese product name: Starano, generic name: ustekinumab, ustekinumab, ustekinumab injection) for the treatment of stage 3 of adult patients with moderate to severe ulcerative colitis (UC) New three-year data for UNIFI's extended study period (LTE)
.

The results showed that among the patients who initially responded to Stelara treatment, most (55.

Although substantial treatment results have been achieved in recent years, many UC patients still struggle to obtain lasting relief from their disease symptoms, especially without the use of steroids.
The long-term use of such drugs may cause debilitating side effects
.

The LTE results of the UNIFI study emphasize the importance of long-term research on therapeutic drugs.

In the intention-to-treat (ITT) population, the clinical response was achieved at the beginning of the maintenance period (maintenance period baseline) and was randomly assigned to Stelara 90 mg once every 8 weeks (q8w) or once every 12 weeks (q12w) among 348 cases: (1 ) 55.
2% of patients (192/348) maintained symptom relief at week 152; (2) 96.
4% (185/192) of patients maintained symptom relief at week 152 without corticosteroid treatment
.

Among the 248 patients who were randomly assigned to Stelara 90mg q8w or q12w at the beginning of the maintenance period and were treated in the extended period (LTE): (1) 67.
6% of patients maintained symptom relief at week 152; (2) 44th Among the patients in clinical remission at week 152, 76.
4% maintained remission at week 152
.

Analysis of the effects of corticosteroids during UNIFI LTE showed that among Stelara patients (n=139) who received corticosteroid therapy at the beginning of the maintenance period, 91.
4% of patients stopped receiving corticosteroid therapy at week 152 (patients in UNIFI The LTE of the study was randomly assigned to Stelara at the beginning)
.

In the 156th week, all patients (n=588) who received treatment during LTE were evaluated for safety
.

From the 0th week of the maintenance period to the 156th week, the follow-up time of patients in the combined Stelara group and placebo group was 1281.

Jan Wehkamp, ​​MD, head of gastroenterology and vice president of Janssen R&D, said: “Jansen has always focused on unmet patient needs and is committed to improving the standard of care for ulcerative colitis (UC)
.

We are proud to work with The gastroenterology community shares these long-term data, especially those patients who are still struggling to control their condition to get relief

Selara is the world's first biologic that can selectively target both IL-12 and IL-23 at the same time
.

IL-12 and IL-23 are two naturally occurring cytokines that are believed to play a key role in immune-mediated inflammatory diseases, including UC, plaque psoriasis, psoriatic arthritis, and Crohn En disease

Stelara was launched in September 2009, and currently approved indications include the treatment of: (1) moderate to severe plaque psoriasis (PsO) adolescents (≥6 years old) and adult patients; (2) active psoriasis Arthritis (PsA) adult patients; (3) moderate to severe Crohn's disease (CD) adult patients; (4) moderate to severe active ulcerative colitis (UC) adult patients

In China, Stelara (Sidano®) was first approved in November 2017.

Stelara is a core product for Johnson & Johnson to enter the field of autoimmune diseases.

Original source: STELARA® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Rates in Adults with Moderately to Severely Active Ulcerative Colitis at Nearly Three Years in Long-Term Extension of Phase 3 Trial

Original source: STELARA® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Rates in Adults with Moderately to Severely Active Ulcerative Colitis at Nearly Three Years in Long-Term Extension of Phase 3 Trial