STELARA ® (ustekinumab) Five-Year Results Presented from Long-term Extension Study of Clinical Response and Remission in Patients with Moderate to Severe Crohn’s Disease

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new, final five-year data from the Phase 3 IM-UNITI open-label, long-term extension (LTE) study which showed treatment of STELARA^® (ustekinumab) in patients with moderate to severe Crohn’s disease (CD) maintained long-term remission^a through five years.^1*

These data are being presented today as an oral presentation (Abstract OP110) at the 28^th United European Gastroenterology (UEG) Week, which is conducting its annual congress virtually.¹

“Crohn’s disease is among the most debilitating forms of inflammatory bowel disease, disrupting the lives of millions of patients worldwide,” said lead study investigator William J. Sandborn,^** M.D., Chief of Gastroenterology, Professor of Medicine, University of California, San Diego, who is delivering the oral presentation virtually at UEG Week. “Results from the IM-UNITI study showed that patients were able to maintain response with ustekinumab treatment through five years. Notably, for those patients in clinical remission, the majority (greater than 90 percent) who received continuous treatment with q12w or q8w ustekinumab were steroid-free at five years.”

The key findings showed more than half of the patients with moderately to severely active CD who were randomised to subcutaneous (SC) ustekinumab every 8 weeks (q8w) and continued to receive this dosage in the LTE study maintained clinical response^b (57 percent) and remission (55 percent) through five years of treatment. Of these patients in clinical remission, 93 percent were steroid-free. Patients who were randomised to SC ustekinumab every 12 weeks (q12w) and continued to receive this dosage in the LTE study also maintained clinical response (54 percent) and remission (45 percent) through five years of treatment. Of these patients in clinical remission, 90 percent were steroid-free.¹

Additionally, among the subgroup of these patients who had never previously been exposed to anti-tumor necrosis factor alpha (TNF-α) biologics, 40 percent and 59 percent were in clinical remission after five years of receiving SC ustekinumab maintenance treatment q12w and q8w, respectively.Further, among the subgroup of these patients who had previously failed (i.e. were refractory to) or who were intolerant to anti TNF-α therapy, 41 percent and 44 percent were in clinical remission after five years of receiving SC ustekinumab maintenance treatment q12w and q8w, respectively.Approximately half (51 percent, [290/567]) of all patients (randomised and assigned) who entered the LTE study completed their final dosing visit.¹

No new safety signals were observed and adverse events (AEs) were generally consistent with previous studies of ustekinumab and the current Summary of Product Characteristics.^1,2 The most common AEs (>5%) in controlled periods of clinical studies with ustekinumab were nasopharyngitis and headache.² Most were considered to be mild and did not necessitate discontinuation of study treatment.²

Through five years, the event rates (per one hundred patient years) for AEs, serious AEs, and serious infections were similar among the q12w and q8w ustekinumab groups and were generally comparable with the event rates in the placebo group. Antibody to ustekinumab rates through week 272 remained low, occurring in six percent of patients assigned to receive ustekinumab in the maintenance study and continuously receiving the approved 90 mg SC q12w or q8w regimen in the LTE.¹

“Crohn’s disease is a chronic, lifelong condition, so it’s important to understand the long-term outcomes of therapies in order to effectively address the disease,” said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “These results from the LTE study with ustekinumab bring us further insights on the long-term management of this chronic disease.”

Janssen is presenting a total of 16 abstracts at this year’s UEG Week congress of which seven are oral presentations.

Key definitions

^a Clinical remission is defined as a Crohn’s Disease Activity index (CDAI) score of <150^3
b Clinical response is defined as a decrease in CDAI score from baseline of ≥100 points (CDAI100), or a CDAI score of <150³

About the IM-UNITI trial⁴

IM-UNITI, a Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel group study, evaluated the efficacy and safety of ustekinumab maintenance therapy in adult patients with moderate to severe Crohn’s disease. Patients who had responded to a single intravenous dose of ustekinumab in the UNITI-1 or UNITI-2 induction studies were randomised equally to receive maintenance SC ustekinumab 90 mg q8w or q12w, or placebo. There were 1,281 patients enrolled in the maintenance study.¹ In randomised patients who met loss of response criteria between weeks 8–32, a one-time dose adjustment to 90 mg q8w occurred. All patients completing week 44 were eligible to enter the long-term extension program, continuing their current regimen up to week 252.

About Crohn’s Disease (CD)

CD is one of the two main forms of inflammatory bowel disease, which affects up to 2 million people across Europe.⁵ CD is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet or other environmental factors.⁶ Symptoms of CD can vary but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever.^6,7 There is currently no cure for CD.⁸

About STELARA^® (ustekinumab)²

Ustekinumab is a fully human monoclonal antibody and is the first and only biologic treatment to selectively inhibit the interleukin (IL)-12 and IL-23 pathways. In the EU, ustekinumab is approved for the treatment of adult patients with moderate to severe CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α 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. In addition to CD and UC, ustekinumab has been approved for the treatment of two further immune-mediated conditions in the EU: psoriasis and psoriatic arthritis.

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 non-biological 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.

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.

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/emea. Follow us at www.twitter.com/JanssenEMEA.

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 the Phase 3 five-year long-term extension study of STELARA^® (ustekinumab) in Crohn’s disease. 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 materialise, actual results could vary materially from the expectations and projections of 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 December 29, 2019, 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.

^* Intention-to-treat analysis for patients originally randomised in the maintenance study is available within the abstract: https://ueg.eu/week/science/programme.
^** Dr William J. Sandborn is a paid consultant for Janssen. He has not been compensated for any media work.

References

1. Sandborn, W, et al.,Efficacy and Safety of Ustekinumab for Crohn’s Disease Through 5 Years: Final Results from the IM-UNITI Long-term Extension (Abstract OP110). Presented at the UEG Week Virtual 2020 Congress October 11–13.
2. European Medicines Agency. STELARA Summary of product characteristics. 2020. Available at: https://www.medicines.org.uk/emc/product/7638/smpc. Accessed October 2020.
3. Feagan BG, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. NEJM 2016;375:1946–60.
4. Clincialtrials.gov. A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI). Identifier: NCT01369355. Available at: https://clinicaltrials.gov/ct2/show/NCT01369355. Accessed October 2020.
5. Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. TheLancet 2017;390:2769-78. Accessed September 14, 2020.
6. Crohn’s and Colitis Foundation. Causes of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed October 2020.
7. Crohn’s and Colitis Foundation. Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed October 2020.
8. Mayo Clinic. Crohn’s disease. Available at https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed October 2020.

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