New STELARA (ustekinumab) Long-Term Data Support its Established Safety Profile in Inflammatory Bowel Disease and Durable Efficacy in Ulcerative Colitis

SPRING HOUSE, PA — The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced final pooled long-term safety results for STELARA^® (ustekinumab) through five years in adults with moderately to severely active Crohn’s disease (CD) and four years in adults with moderately to severely active ulcerative colitis (UC), as well as final four-year clinical and endoscopic outcomes from the UNIFI long-term extension (LTE) study evaluating the efficacy of STELARA for the treatment of adults with moderately to severely active UC.^1,2 These data are a part of Janssen’s 22 oral and poster presentations at the 18^th Congress of the European Crohn’s and Colitis Organization (ECCO), taking place in Copenhagen, Denmark, March 1-4.

“These data reinforce the known efficacy and safety profile of STELARA, and demonstrate it can be an effective long-term treatment option for patients living with moderately to severely active ulcerative colitis,” said UNIFI study author Waqqas Afif, M.D., Associate Professor, Department of Medicine, Division of Experimental Medicine and Division of Gastroenterology at McGill University Health Centre in Montreal, Canada.^a “Importantly, clinical and endoscopic outcomes reinforce the durable efficacy of STELARA, as we remain committed to developing therapies that provide patients with lasting remission.”

Final STELARA long-term pooled safety analysis (Oral presentation OP39):¹

A final pooled safety analysis of six Phase 2/3 IBD studies included 2,575 patients treated with STELARA and a total of 4,826 patient-years (PY) of follow-up.

• Overall safety profile: Data continue to support a well-established safety experience in adult patients with moderately to severely active ulcerative colitis (UC) through up to four years, and in adult patients with moderately to severely active Crohn’s disease (CD) through five years.
• Key safety events: Key safety event rates adjusted per 100 PYs for adverse events (AEs), serious AEs, infections, serious infections, major adverse cardiac events (MACE), and malignancies were similar between placebo and STELARA.
• Adverse events: The most frequently occurring adverse events (AEs) per 100 PY of follow-up (excluding disease related AEs under study) were headache (11.60 STELARA versus 16.66 placebo), arthralgia (11.23 STELARA versus 15.91 placebo), abdominal pain (9.86 STELARA versus 13.79 placebo), nausea (7.13 STELARA versus 11.35 placebo), and pyrexia (5.91 STELARA versus 11.35 placebo). The most frequently reported serious infections of anal abscess, pneumonia, cellulitis, and abdominal abscess were similar between STELARA and placebo, except gastroenteritis (0.25 STELARA versus 0.11 placebo). The most frequently reported infections were nasopharyngitis (19.10 STELARA versus 17.82 placebo) and upper respiratory tract infection (9.80 STELARA versus 11.78 placebo).

Final UNIFI LTE clinical and endoscopy outcomes through four years from STELARA treatment (Oral presentation OP15):² Results from the UNIFI LTE study, among 205 adult patients^b with a history of moderate to severe UC who had achieved clinical response to treatment with intravenous (IV) STELARA, were randomized to STELARA 90 mg every eight weeks (q8w) or every 12 weeks (q12w)^c at baseline of the maintenance study, and continued treatment in the LTE, showed that at week 200:^d

• 58 percent (119/205) of patients were in clinical remission^e
• 80 percent (164/205) of patients were in clinical response^f
• 79.5 percent (163/205) of patients were in modified Mayo score response^g
• 67 percent (138/205) of patients showed endoscopic improvement^h

“These long-term studies underscore Janssen’s commitment to developing novel therapies addressing unmet medical need,” said Jan Wehkamp, M.D., Ph.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “Our findings reinforce our confidence in STELARA as a therapy of choice for patients seeking lasting relief from inflammatory bowel disease.”

Notes:

a. Dr. Afif received grant support from Janssen. He has not been compensated for any media work.
b. Patients were randomized to STELARA at maintenance baseline and continued treatment in the LTE, who either had Mayo score data (including endoscopy) at week 200 or had experienced treatment failure²
c. q12w dosing is not currently approved for STELARA in the U.S.; current approved dosing is a subcutaneous 90 mg dose eight weeks after initial intravenous dose, then every eight weeks thereafter³
d. Patients who had treatment failure (i.e., had ostomy or colectomy or discontinued STELARA due to lack of therapeutic effect or worsening UC) before week 200 were also included, and were imputed as nonresponders.²
e. Clinical remission is defined as a Mayo score ≤2 points and no individual subscore >1²
f. Clinical response is defined as a decrease in Mayo score of ≥30% and ≥3 points from induction baseline with either a decrease in rectal bleeding subscore of ≥1 from induction baseline or a rectal bleeding subscore of 0 or 1²
g. Modified Mayo score (without Physician’s Global Assessment subscore) response is defined as a decrease in modified Mayo score of ≥30% and ≥2 points from induction baseline with either a decrease in rectal bleeding subscore of ≥1 from induction baseline or a rectal bleeding subscore of 0 or 1²
h. Endoscopic improvement, endoscopic healing, or mucosal healing is defined as an endoscopy subscore of 0 or 1²

References

1. Ghosh, S, et al. Safety of Ustekinumab in IBD: Final Pooled Long-Term Safety Analysis Through 5 Years in CD and 4 Years in UC. Presented at 18^th Congress of ECCO, March 1-4.
2. Danese, S, et al. Efficacy of Ustekinumab for Ulcerative Colitis Through 4 Years: Final Clinical and Endoscopy Outcomes from the UNIFI Long-Term Extension. Presented at the 18^th Congress of ECCO, March 1-4.
3. STELARA^® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf. Accessed February 2023.
4. National Institutes of Health: Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI). Identifier: NCT02407236. Available at: https://clinicaltrials.gov/ct2/show/NCT02407236. Accessed February 2023.
5. Crohn’s & Colitis Foundation of America. The Facts About Inflammatory Bowel Diseases. Available at https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed February 2023.
6. Crohn’s & Colitis Foundation. What is Ulcerative Colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed February 2023.
7. Crohn’s & Colitis Foundation. Overview of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed February 2023.
8. Crohn’s & Colitis Foundation. What is Crohn’s disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed February 2023.
9. Crohn’s & Colitis Foundation. Signs and Symptoms of Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms. Accessed February 2023.

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