SCOTTISH MEDICINES CONSORTIUM (SMC) ACCEPTS STELARA® (USTEKINUMAB) FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN SCOTLAND

SCOTTISH MEDICINES CONSORTIUM (SMC) ACCEPTS STELARA^® (USTEKINUMAB) FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN SCOTLAND

 

STELARA^® (ustekinumab) is the first approved treatment to selectively target the IL-12/IL-23 pathways, an important therapeutic target in ulcerative colitis

 

High Wycombe, UK, Wednesday 15^th April 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson welcomes the Scottish Medicines Consortium’s (SMC) decision to accept STELARA^® (ustekinumab) for use within NHS Scotland for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.[i]

 

UC is a chronic immune-mediated inflammatory disease of the rectum and large intestine, affecting approximately 23,500 people in Scotland, for which there is currently no cure.[ii]^,[iii] For up to one-third of people with UC, current treatments are not completely successful or complications may arise, where surgery may be considered.[iv]^{,[v],[vi],[vii],[viii]}

 

“Crohn’s & Colitis UK are extremely pleased that people in Scotland living with ulcerative colitis may now benefit from this treatment option. The personal impact of uncontrolled symptoms of colitis can be devastating and debilitating and can severely affect a person’s daily living and activity. Having many treatment options available to doctors is hugely beneficial for patient outcomes,” commented Elaine Steven, Health Service Programme Manager, Crohn’s & Colitis UK^*. “This decision is particularly welcome during the COVID-19 crisis ensuring patients have access to a wide range of treatment options while supporting the NHS and IBD Services against further pressures on already stretched services. Our thanks go to the SMC for not delaying the publication of this decision at this critical time.”

 

Ustekinumab is the first biologic therapy for UC that targets interleukin (IL)-12 and IL-23 cytokines, known to play a key role in inflammatory and immune responses, offering clinicians and patients a new mechanism of action for treating UC. [ix]^,[x]

 

“The approval of ustekinumab for ulcerative colitis by SMC is very welcome and timely news. This provides an effective and convenient new drug for clinicians to use in patients with UC, who are in need of new treatment options,” commented Professor Charlie Lees**, Consultant Gastroenterologist, Western General Hospital, Edinburgh. “It was only six years ago in Scotland that no biologics were approved for moderate to severely active ulcerative colitis. We now have an armamentarium of effective treatments that can get patients well, to a better quality of life and keep them off steroids and out of hospital.”

 

The SMC advice is based on data from the pivotal Phase 3 UNIFI trial programme which evaluated ustekinumab’s safety and efficacy as a treatment option for adult patients with moderately to severely active UC. The programme was split into an initial Induction study (UNIFI-I) of eight weeks, followed by a Maintenance study (UNIFI-M) of 44 weeks. All patients who were randomised into the 44-week Maintenance study were induction responders to IV ustekinumab. Among patients subsequently randomised to receive subcutaneous ustekinumab (q8w or q12w), a significantly greater percentage achieved clinical remission at week 44 vs initial responders randomised to placebo (44 percent and 38 percent, vs 24 percent, p<0.001 and p=0.002, respectively).¹⁰

 

Jennifer Lee, EMEA Therapy Area Market Access Lead for Immunology, Janssen-Cilag Limited, commented “We are pleased with the SMC’s decision to accept ustekinumab for use within NHS Scotland for eligible patients living with ulcerative colitis. We have a long-standing commitment to developing innovative therapies to improve the lives of those living with immune-mediated inflammatory diseases. The advice from the SMC reflects the true need for new treatment options for patients living with moderately to severely active ulcerative colitis.”

 

Ustekinumab has demonstrated a safety profile in UC where trials show the treatment is generally well tolerated. Through to week 44, the proportions of patients receiving ustekinumab (q12w and q8w) were comparable to those receiving placebo in terms of the reporting of at least one adverse event (AE) (69.2%, 77.3% and 78.9%, respectively), serious AEs (7.6%, 8.5% and 9.7% respectively), infections (33.7%, 48.9% and 46.3%, respectively) and serious infections (3.5%, 1.7% and 2.3%, respectively). Overall, the safety for ustekinumab in UC patients was consistent with the known safety profile of ustekinumab in Crohn’s disease (CD).¹⁰

 

Ustekinumab is already accepted by the SMC as a clinical and cost-effective option for the treatment of Crohn’s disease (CD) and for restricted use in plaque psoriasis and psoriatic arthritis.[xi]^,[xii]^,[xiii]^,[xiv]

 

ENDS

 

*Janssen has provided Crohn’s & Colitis UK with core funding for disease awareness and membership engagement activities. Crohn’s & Colitis UK has not been compensated for any media work.

**Professor Lees has received consultancy honoraria from Janssen. He has not been compensated for any media work.

 

About Ulcerative Colitis (UC)

UC is a chronic disease of the large intestine, also known as the colon, and the rectum, in which the lining becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucous. UC is the result of an abnormal response by the body's immune system. The symptoms of UC can vary greatly from person to person and can be painful, embarrassing and debilitating, placing a significant burden on those with the condition.[xv]^,[xvi] Symptoms may include loose and more urgent bowel movements, persistent diarrhoea, abdominal pain, bloody stools, loss of appetite, weight loss and fatigue.¹⁶

 

About STELARA^® (ustekinumab)[xvii]

In the UK and EU, ustekinumab is approved for the treatment of adult patients with moderately to severely active 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.

 

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

The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis 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 was similar for patients with psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.¹⁷

 

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

 

About the UNIFI Programme

UNIFI is a Phase 3 clinical trial, designed to evaluate the safety and efficacy of ustekinumab induction and maintenance dosing for the treatment of moderate to severe 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 and/or vedolizumab) therapies.¹⁰

 

Both the induction and maintenance studies are randomised, double‑blind, placebo-controlled, parallel group, multicentre studies. The induction study was conducted over a duration of at least 8 weeks for each participant. Participants achieving clinical response in the induction study were eligible for the maintenance study.¹⁰

 

The maintenance study was 44 weeks in duration. The primary endpoint of the induction study was clinical remission at week 8, and the primary endpoint for the maintenance study was clinical remission at week 44 among responders to a single IV ustekinumab infusion. Following completion of the maintenance study, a long-term extension study is following eligible participants for an additional three years.¹⁰

 

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.

 

Janssen-Cilag Limited is a Janssen Pharmaceutical Company of Johnson & Johnson. Learn more at www.janssen.com/uk. Follow us at www.twitter.com/JanssenUK.

 

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding SMC’s acceptance 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 materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag Limited, 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 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.

 

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References

 

 

[i] Scottish Medicines Consortium. Ustekinumab (Stelara) (UC). Available from: https://www.scottishmedicines.org.uk/medicines-advice/ustekinumab-stelara-full-smc2250/. Accessed April 2020.

[ii] Crohn's & Colitis UK. Scotland Leading The Way: a national blueprint for inflammatory bowel disease in Scotland. 2016 Available from: https://crohnsandcolitis.org.uk/improving-care-services/health-services/scotland-leading-the-way. Accessed April 2020.

[iii] Jones R, et al. IBD prevalence in Lothian, Scotland, derived by capture–recapture methodology. Gut 2019;68:1953-1960.

[iv] Lopez-Sanroman A, et al. Perceived emotional and psychological impact of ulcerative colitis on outpatients in Spain: UC-LIFE survey. Dig Dis Sci 2017;62:207-216.

[v] Rubin D, et al. The impact of ulcerative colitis on patients’ lives compared to other chronic diseases: A patient survey. Dig Dis Sci 2010;55:1044–1052.

[vi] Devlen J, et al. The burden of inflammatory bowel disease: A patient-reported qualitative analysis and development of a conceptual model. Inflamm Bowel Dis 2014:20:545–552.

[vii] Lonnfors S, et al. IBD and health-related quality of life – Discovering the true impact. J Crohn’s Colitis 2014;8:1281–1286.

[viii] Crohn’s and Colitis Foundation: Treatment Options. Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis/treatment-options. Accessed April 2020.

[ix] Toussirot E. The IL23/Th17 pathway as a therapeutic target in chronic inflammatory diseases. Inflamm Allergy Drug Targets 2012;11(2):159–68.

[x] Sands B, et al. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med 2019; 381:1201-1214.

[xi] Scottish Medicine Consortium. 2010. Ustekinumab (Stelara) (PsO adults). Available at: https://www.scottishmedicines.org.uk/medicines-advice/ustekinumab-stelara-fullsubmission-57209/. Accessed April 2020.

[xii] Scottish Medicine Consortium. 2014. Ustekinumab (Stelara) (PsA). Available at: https://www.scottishmedicines.org.uk/medicines-advice/ustekinumab-stelara-fullsubmission-94414/. Accessed April 2020.

[xiii] Scottish Medicine Consortium. 2016. Ustekinumab (Stelara) (PsO 12yrs+). Available at: https://www.scottishmedicines.org.uk/medicines-advice/ustekinumab-stelara-abbreviatedsubmission-111515/. Accessed April 2020.

[xiv] Scottish Medicine Consortium. 2017. Ustekinumab (Stelara) (CD). Available at: https://www.scottishmedicines.org.uk/medicines-advice/ustekinumab-stelara-fullsubmission-125017/. Accessed April 2020.

[xv] 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 April 2020.

[xvi] Crohn's & Colitis UK. What is Ulcerative Colitis? Available at: https://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/ulcerative-colitis. Accessed April 2020.

[xvii] European Medicines Agency. Stelara SmPC. 2019. https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf. Accessed April 2020.