New drug for ulcerative colitis (UC)! 4-year data from the Stelara Phase 3 study: Sustained symptom relief & corticosteroid-free relief!

Stelara has been approved in China for 2 indications: plaque psoriasis and Crohn's disease
.

October 20, 2022 /BioValleyBIOON/ --Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced the anti-inflammatory drug Stelara (Chinese trade name: Starno, generic name: ustekinumab) at the 30th European Digestive Week 2022, Usenumab injection) in adults with moderately to severely active ulcerative colitis (UC) Phase 3 UNIFI study (NCT02407236) long-term extension (LTE).

The results presented at the meeting confirmed the sustained efficacy and good safety profile
of Stelara treatment for up to 4 years.
Specifically: 64.
9% of patients who achieved a clinical response during the Stelara induction therapy period were in symptom remission at week 44 of the maintenance period, compared to 55.
2%
at week 200 (4 years).
In addition, the majority (96.
4%) of patients with symptom relief at week 200 did not use corticosteroid-free, i.
e.
, no corticosteroid remission
.

Of the 174 patients who received Stelara as the first biologic-naive treatment for UC, 71.
8% (n=125) were in symptom remission at week 44 of the maintenance period and 67.
2% (n=117) were in symptomatic remission
at week 200.

Another analysis of the UNIFI LTE study presented at the meeting showed that the majority (79.
1%) of Stelara randomized patients who received corticosteroids at baseline during the maintenance period and Stelara during LTE were able to eliminate corticosteroid use
by week 200.

Waqqas Afif, Associate Professor of Experimental Medicine and Gastroenterology, McGill University Health Centre, Montreal, Canada, who presented the UNIFI findings at the conference and author of the UNIFI findings, said: "The final LTE results of the UNIF study suggest that Stelara can be an effective long-term treatment option for patients with moderately to severely active UC, including biologic-naïve patients
.
Importantly, the vast majority of patients who achieved remission in the study were able to eliminate the use of corticosteroids, which can cause significant side effects and are not a long-term treatment for
the disease.
”

Stelara targets inhibition of the cytokines IL-12/IL-23 (Image source: stelarainfo.
com)

- Efficacy data from the UNIFI LTE study at week 200: 348 patients in the intention-to-treat (ITT) population who achieved a clinical response at the beginning of the maintenance period (maintenance period baseline) and were randomized to Stelara 90mg every 8 weeks (q8w) or every 12 weeks (q12w): (1) 55.
2% of patients (192/348) maintained symptom relief at week 200, At week 44 (at the end of the major maintenance treatment study), the proportion was 64.
9% (226/348).

(2) 53.
2% of patients (185/348) achieved corticosteroid-free remission at week 200, compared with 63.
5% (221/348)
at week 44.
(3) Of the 174 biologic-naïve patients randomized to Stelara at the baseline of the maintenance period, 67.
2% (117/174) maintained symptom remission at week 200, compared with 71.
8% (125/174)
at week 44.
(4) Of the patients in clinical remission at week 44, 72.
9% were also in symptomatic remission
at week 200.
(5) Of the 284 randomized patients who entered the study LTE phase after week 44 of the maintenance period and continued to receive Stelara treatment (q8w or q12w), 67.
6% (192/284) were in symptom remission
at week 200.

Safety data from the UNIFI LTE study at week 200: All patients treated with LTE phase (n=588) were evaluated for safety at week 200, including randomized and non-randomized populations
.
Throughout the study, the rate of critical safety events in patients treated with Stelara was similar
to that of placebo.
From week 0 to week 200 of the maintenance period, patients in the combined Stelara group and placebo group were followed up for 1647.
4 and 301.
7 patient-years (PY),
respectively.
The events safe per 100PY at follow-up were as follows: adverse events (AE) were 214.
45 in the Stelara group and 288.
04 in the placebo group; serious adverse events (SAE) were 7.
22 in the Stelara group and 10.
61 in the placebo group; and serious infections, 2.
00 in the Stelara group and 3.
31
in the placebo group.
No new safety signals were observed
.

- Corticosteroid-Scheduling data from the UNIFI LTE study at week 200: An analysis of the effects of corticosteroids during UNIFI LTE showed that 79.
1% of Stelara randomized patients (n = 139) who received corticosteroids at baseline during the maintenance period and Stelara during LTE were no longer receiving corticosteroids
at week 200 。 In patients randomized to Stelara at maintenance baseline and treated with Stelara in the LTE phase: Corticosteroid-free symptom response rates at week 200 were similar overall in
the q8w (63.
6 percent [91/143]) and q12w groups (66.
7 percent [94/141]).
Of the patients treated with Stelara who were in symptomatic remission at week 200, 94.
8% of patients in the q8w group and 97.
9% of the q12w group were steroid-free
.

Inflammatory bowel disease (IBD) includes ulcerative colitis (UC) and Crohn's disease (CD).

UC is a chronic IBD that affects the large intestine (colon), where the lining of the colon becomes inflamed, forming tiny, open sores that produce pus and mucus
.
The disease is the result of an overreaction by the immune system, and symptoms vary from patient to patient, but may include poor stools, frequent bowel movements, persistent diarrhea, abdominal pain, bloody stools, loss of appetite, weight loss, and fatigue
.

Selara is the world's first biologic 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 immune-mediated inflammatory diseases, including UC, plaque psoriasis, psoriatic arthritis, Crohn's disease, and more
.
Stelara inhibits these two pro-inflammatory cytokines
by binding to the p40 subunit shared by IL-12 and IL-23, preventing it from binding to the cell surface receptor IL-12 β1.

Stelara was launched in September 2009 and has been approved for the treatment of: (1) children (≥ 6 years old) and adult patients with moderate to severe plaque psoriasis (PsO); (2) Children (≥ 6 years old) and adult patients with active psoriatic arthritis (PsA); (3) Adult patients with moderate to severe Crohn's disease (CD); (4) Adult patients
with moderately to severe active ulcerative colitis (UC).

In China, Stelara ® was first approved in November 2017 and has been approved for two indications so far: (1) for adult patients with moderate to severe plaque psoriasis (PsO) who do not respond to, contraindication, or cannot tolerate other systemic treatments such as cyclosporine, methotrexate (MTX) or PUVA (psoralen and ultraviolet A); (2) Suitable for adult patients
with moderate-to-severe active Crohn's disease (CD) who have insufficient response to traditional treatment or tumor necrosis factor α (TNFα) antagonists, lose response, or cannot tolerate it.
(Bio Valley Bioon.
com)

STELARA® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Through Four Years in Adults with Moderately to Severely Active Ulcerative Colitis