New three-year data from the long-term extension of the STELARA® Phase 3 UNIFI study presented at ECCO 2021

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

 

55.2 percent of patients were in symptomatic remission and 96.4 percent of patients were in corticosteroid-free remission at week 152

 

New data from the UNIFI study is one of 22 Janssen abstracts, including five oral and three digital oral presentations, at the 16^th Congress of the European Crohn’s and Colitis Organisation

 

High Wycombe, UK, 12 July, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new three-year data from the long-term extension (LTE) of the STELARA^® (ustekinumab) Phase 3 UNIFI study. The data demonstrated the majority (55.2 percent) of adult patients with moderately to severely active ulcerative colitis (UC) who initially responded to treatment with ustekinumab sustained symptomatic remission^a rates at nearly three years (week 152).¹ Furthermore, a majority (96.4 percent) of the patients in symptomatic remission^a at week 152 were corticosteroid-free. These data are being presented today as a digital oral presentation (DOP83) at the 16^th Congress of the European Crohn’s and Colitis Organisation.¹

 

“Despite recent substantial therapeutic gains, many patients living with ulcerative colitis still struggle to find lasting relief from their disease symptoms, especially without the use of steroids that can be associated with debilitating side effects when used long-term,” said Bruce E. Sands, M.D., M.S., Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Dr. Burrill B. Crohn Professor of Medicine (Gastroenterology) at the Icahn Institute for Medicine at Mount Sinai.^b “The LTE of the UNIFI study underscores the importance of studying therapies long-term, with results showing ustekinumab as both an effective and enduring treatment option for patients living with moderately to severely active ulcerative colitis.”

 

Of the 348 patients in the intent-to-treat population^c who had achieved clinical response at maintenance baseline and were randomised to ustekinumab 90 mg every eight weeks (q8w) or every 12 weeks (q12w):¹

• 2 percent of patients were in symptomatic remission^a at week 152.
• 4 percent (185/192) of patients in symptomatic remission^a at week 152 were not receiving corticosteroids.

 

Of the 284 patients randomised to ustekinumab 90 mg q8w or q12w at maintenance baseline and treated in the LTE:^1,d

• 6 percent of patients were in symptomatic remission^a at week 152.
• 4 percent of patients in clinical remission at week 44 were in symptomatic remission^a at week 152.^e

 

Safety was evaluated at week 156 for all patients (n=588) who were treated in the LTE.¹ From maintenance week 0 through week 156, combined ustekinumab patients and placebo patients had 1,281.6 and 425 patient-years (PYs) of follow-up, respectively.¹ Safety events per 100 PYs of follow-up were as follows: adverse events (AEs) 235.81 for ustekinumab vs 204.48 for placebo; serious adverse events (SAEs) 7.73 for ustekinumab vs 7.53 for placebo, and serious infections 2.34 for ustekinumab vs 2.35 for placebo. No new safety signals were observed.^1,2

 

Results from a separate digital oral presentation (DOP86) on corticosteroid-sparing effects within the UNIFI LTE show 91.4 percent of ustekinumab patients (n=127) receiving corticosteroids at maintenance baseline (n=139) were no longer receiving corticosteroids at week 152 (patients were randomised to ustekinumab at the start of the LTE of the study).³

 

“Janssen is relentlessly focused on unmet patient needs and committed to improving the standard of care in ulcerative colitis,” said Jan Wehkamp, MD, Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “We are proud to share these long-term data among the gastrointestinal community, especially for patients who are still struggling to manage their disease and achieve remission.”

 

#ENDS#

 

Footnotes:

1. Symptomatic remission is defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.¹ Symptomatic remission results refer to the ustekinumab 90 mg q8w and q12w combined group.¹
2. Dr Sands is a paid consultant for Janssen. He has not been compensated for any media work.
3. All patients were randomised to ustekinumab at maintenance baseline with non-responder imputation (NRI) and treatment failure criteria.¹
4. Included treatment failure and missing data utilising NRI.¹
5. Clinical remission is defined as a Mayo score ≤2 points, with no individual subscore >1.¹

 

About the UNIFI Trial (NCT02407236; EudraCT 2014-005606-38)^4,5
UNIFI is a Phase 3 study designed to evaluate the safety and efficacy of ustekinumab induction and maintenance dosing for the treatment of moderately to severely active UC in adults who demonstrated an inadequate response to or were unable to tolerate conventional (i.e., corticosteroids, immunomodulators) or biologic (i.e., one or more TNF blockers or vedolizumab) therapies. Both the induction and maintenance studies are randomised, double-blind, placebo-controlled, parallel group, multi-centre studies.^4,5

 

The induction study was at least eight weeks duration for each participant.⁴ Participants achieving clinical response in the induction study were eligible for the maintenance study.⁴ The maintenance study was 44 weeks duration.⁴ The primary endpoint of the induction study was clinical remission at week eight, and the primary endpoint for the maintenance study was clinical remission at week 44 among responders to a single intravenous (IV) ustekinumab infusion.⁴ 523 intravenous ustekinumab induction responders were randomised to subcutaneous (SC) maintenance therapy (175 SC placebo; 172 ustekinumab 90 mg every 12 weeks; 176 ustekinumab 90 mg q8w).¹ 284 ustekinumab patients who completed week 44 entered the LTE.¹ Randomised placebo patients were discontinued after week 44 unblinding.¹ Starting at week 56, randomised patients with UC worsening could adjust to q8w dosing.¹ Efficacy was evaluated in randomised patients using symptomatic remission.^a Safety was evaluated for all 588 patients who were treated in the LTE, including the randomised and non-randomised populations.¹ Through week 156, 131 patients continued on placebo and 457 patients received ustekinumab.¹ The non-randomised population included ustekinumab induction non-responders at week eight who received SC ustekinumab and responded eight weeks later, and responders to placebo induction.¹

 

About Ulcerative Colitis

UC affects up to 146,00 people in the UK.6 It is a chronic disease of the large intestine, also known as the colon, in which the lining becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucous.⁷ UC is the result of an abnormal response by the body's immune system.⁷ Symptoms vary, but may include loose and more urgent bowel movements, persistent diarrhoea, abdominal pain, bloody stools, loss of appetite, weight loss and fatigue.^7,8

 

 

About STELARA^® (ustekinumab)²

Ustekinumab is a fully human monoclonal antibody and is the first biologic treatment to selectively inhibit the interleukin (IL)-12 and IL-23 pathways.² In the UK and EU, ustekinumab is approved for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-alpha antagonist, or have medical contraindications to such therapies. Ustekinumab is also approved for the treatment of adults with moderately to severely active UC who have had an inadequate response with, or lost response to, or were intolerant to either conventional therapy or a biologic, or have medical contraindications to such therapies.²

Ustekinumab is approved alone or in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis in adult patients when the response to previous nonbiological disease-modifying antirheumatic drug therapy has been inadequate. Ustekinumab is also approved for the treatment of moderate to severe plaque psoriasis in children and adolescent patients aged six years and older who are inadequately controlled by, or are intolerant to other systemic therapies or phototherapies, and is also approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, MTX or psoralen plus ultraviolet A.²

 

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA^®.

 

Important Safety Information²

The most common AEs (>5%) in controlled periods of clinical studies with ustekinumab were nasopharyngitis and headache. Most were considered to be mild and did not necessitate discontinuation of study treatment. The most serious adverse reaction that has been reported for ustekinumab is serious hypersensitivity reactions, including anaphylaxis. The overall safety profile is similar for adult patients with CD, UC, psoriasis, and psoriatic arthritis.²

Please refer to the Summary of Product Characteristics for full prescribing information for ustekinumab: https://www.medicines.org.uk/emc/product/7638/smpc.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

 

Learn more at www.janssen.com/uk.

Follow us at www.twitter.com/JanssenUK.

 

Janssen-Cilag International NV, the marketing authorisation holder for STELARA^® in the EU, and Janssen Research & Development, LLC, are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

 

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding ongoing and planned development efforts involving STELARA^® (ustekinumab) in ulcerative colitis. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

 

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References

 

1. Abreu MT, et al. Efficacy and Safety of Ustekinumab for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension (Abstract DOP83). Presented at the 16^th Congress of ECCO July 8-10, 2021.
2. European Medicines Agency. STELARA Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/7638/smpc. Accessed July 2021.
3. Scherl EJ, et al. Corticosteroid-Sparing Effects of Ustekinumab Therapy for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension (Abstract DOP86). Presented at the 16^th Congress of ECCO July 8-10, 2021.
4. 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 July 2021.
5. eu. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis. Identifier: 2014-005606-38. Available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-005606-38/DE. Accessed July 2021.
6. Conditions overview. Ulcerative Colitis. Available at: https://www.nhs.uk/conditions/ulcerative-colitis/. Accessed July 2021.
7. Crohn's & Colitis UK. What is Ulcerative Colitis? Available at: https://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/ulcerative-colitis. Accessed July 2021
8. Crohn’s & Colitis Foundation. ‘Living with Ulcerative Colitis’ leaflet. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/living-with-ulcerative.pdf. Accessed July 2021.