New Phase 3b Interim Data from STARDUST Study Show Two-Thirds of Patients with Moderately to Severely Active Crohn’s Disease Achieved Clinical Remission After Two Doses of STELARA® (ustekinumab)

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced interim data from the Phase 3b STARDUST study. At week 16, 79 percent of patients with moderately to severely active Crohn’s disease (CD) achieved clinical response^a and 67 percent were in clinical remission^b after receiving one ~6 mg/kg intravenous (IV) dose followed by one 90 mg subcutaneous (SC) dose of STELARA^® (ustekinumab), open label.¹ Intestinal ultrasound (IUS) responses were assessed and were detected as early as week 4.² Week 16 data (digital oral presentation or DOP 13) and IUS response data (DOP 10) from STARDUST are being presented as part of a digital oral presentation at the 15^th Congress of the European Crohn’s & Colitis Organisation (ECCO).^1,2

The primary endpoint of the 48-week STARDUST study is comparative endoscopic response^c among adult patients with CD receiving ustekinumab maintenance therapy.³ At week 16, patients who achieved a ≥70 point decrease in Crohn’s Disease Activity Index score^d (CDAI70 responders) were randomised into treat-to-target or routine standard of care treatment groups at a 1:1 ratio.³

Of the 220 CDAI70 responders randomised in the treat-to-target arm, 37 percent achieved endoscopic response at week 16.¹ Endoscopy at week 16 was measured only in the treat-to-target group.³ Treat-to-target is a proactive treatment strategy where frequently monitored outcomes, like endoscopic response, biomarkers and clinical symptoms, guide use of the medication.⁴ STARDUST is the first study of a treat-to-target strategy in CD using endoscopic response to guide treatment.

“Crohn’s disease patients may respond to treatment while continuing to experience internal inflammation that can cause irreversible damage. These patients may benefit from a more proactive, robust treatment approach and less invasive monitoring methods,” said Professor Silvio Daneseⁱ, Head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital, Milan, Italy and principal investigator. “I am encouraged by these data that demonstrate the potential clinical utility of the noninvasive IUS method in helping guide treatment of CD and look forward to forthcoming data that may help us better understand the possible benefits of a treat-to-target strategy.”

IUS is a complementary method of assessing CD activity, based upon measuring transmural bowel features, like thickness of the bowel wall and presence of hypervascularisation.⁵ STARDUST is the first study to use IUS for monitoring CD patients in an interventional setting. Future studies need to confirm whether early IUS response at week 4 is predictive of longer-term (i.e., week 16 and up to week 48) clinical and endoscopic outcomes for CD patients.

STARDUST week 16 interim analysis includes 500 participants with moderately to severely active CD receiving an IV induction dose of ustekinumab ~6 mg/kg, followed by an ustekinumab 90 mg SC injection at week 8.¹ In the interim analysis, patient response was assessed up to week 16. Participants were either naïve to prior biologics or had previously been exposed to no more than one biologic medicine. At week 16, the safety profile for ustekinumab in STARDUST was consistent with the established safety profile observed in Phase 3 inflammatory bowel disease (IBD) clinical trials, as well as that seen in other indications.^6,7

As in the current prescribing information, the most common adverse events (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 previously been reported for ustekinumab is serious hypersensitivity reactions, including anaphylaxis. The overall safety profile is similar for adult patients with CD, ulcerative colitis (UC), psoriasis, and psoriatic arthritis.⁶

“STARDUST represents a significant milestone in our commitment to helping Crohn’s disease patients and the physicians who treat them,” said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “The data from this study may provide us with key clinical insights which may inform future treatment strategies.”

Janssen is presenting a total of 23 abstracts at this year’s ECCO congress. Ustekinumab is currently approved for the treatment of adults with moderately to severely active CD in the U.S., Canada, the European Union (EU) and Japan.

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Key definitions
^a Clinical response is defined as a decrease in Crohn’s Disease Activity index (CDAI) score from baseline of ≥100 points (CDAI100), or a CDAI score of <150.^8
b Clinical remission is defined as a CDAI score of <150.^8
c Endoscopic response was defined by a 50 percent reduction from baseline in simple endoscopic score (SES-CD).^3
d CDAI is a frequently used measure to assess the severity of CD, giving a score from 0–600; a higher score indicates more severe disease activity.⁸

About the STARDUST Trial ³
STARDUST is a randomised, international, multi-centre, interventional Phase 3b study evaluating the proportion of patients with endoscopic response, defined as a ≥50% reduction from baseline in simple endoscopic score for Crohn’s disease (SES-CD) at week 48. STARDUST is evaluating 500 participants receiving an IV induction dose of ustekinumab 6 mg/kg, followed by an ustekinumab 90 mg SC injection at week 8. At week 16, patients with a CDAI reduction of ≥70 points (CDAI70) were randomised to treat-to-target or standard of care treatment arms (1:1 ratio) and will be followed through the end of the study (48 weeks). Primary endpoint data are anticipated for presentation later this year.

About Crohn’s Disease (CD)
CD is one of the two main forms of IBD, which affect up to 1.7 million people across Europe.⁹ 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. Symptoms of CD can vary but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever.¹⁰ There is currently no cure for CD.¹¹

About STELARA^® (ustekinumab) ⁶
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‑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. 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 information ⁶
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 regulatory approvals and benefits of a new treatment option for STELARA^® (ustekinumab). 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-Cilag International NV, and 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 30 December, 2018, 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. Danese S, et al. Clinical and endoscopic response to ustekinumab in Crohn’s Disease: Week 16 interim analysis of the STARDUST trial [Presentation for DOP13] Presented at the 15th Congress of the European Crohn’s & Colitis Organization (ECCO) 12-15 February 2020; Vienna, Austria.
2. Kucharzik T, et al. Intestinal ultrasound response and transmural healing after ustekinumab induction in Crohn’s Disease: Week 16 interim analysis of the STARDUST trial substudy. [Presentation for DOP10] Presented at the 15th Congress of the European Crohn’s & Colitis Organization (ECCO) 12-15 February 2020; Vienna, Austria.
3. ClinicalTrials.gov. Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab (STARDUST). Identifier NCT03107793. Available at: https://clinicaltrials.gov/ct2/show/NCT03107793. Accessed February 2020.
4. Smolen J, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task. Ann Rheum Dis 2015;0:1–13.
5. Fraquelli M, et al. Impact of intestinal ultrasound on the management of patients with inflammatory bowel disease: how to apply scientific evidence to clinical practice. Dig Liver Dis 2020;52:9–18.
6. European Medicines Agency. STELARA Summary of product characteristics. 2020. Available at: https://www.medicines.org.uk/emc/product/7638/smpc. Accessed February 2020.
7. Sandborn WJ, et al. Long-term efficacy and safety of ustekinumab for Crohn's disease through the second year of therapy. Aliment Pharmacol Ther 2018;48:65–77.
8. Feagan BG, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. NEJM 2016;375:1946–60.
9. Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet 2017;390:2769-78.
10. Crohn’s and Colitis Foundation. Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed February 2020.
11. Mayo Clinic. Crohn’s disease. Available at https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed February 2020.

ⁱ Professor Danese is a paid consultant for Janssen. He has not been compensated for any media work.

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February 2020

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