UZPRUVO®▼ (ustekinumab)
UZPRUVO
Uzpruvo is STADA’s ustekinumab biosimilar and offers a cost-effective alternative to the reference product.1-3
Uzpruvo is indicated for the treatment of moderate to severe Crohn’s disease in adults, moderate to severe plaque psoriasis in adults, moderate to severe paediatric plaque psoriasis and psoriatic arthritis in adults.1
Prescribing Information can be found here
Autoimmune disease
The prevalence of autoimmune diseases is increasing worldwide,4 affecting approximately one in ten individuals in the UK alone.5
Prevalence of autoimmune diseases relevant to Uzpruvo’s therapeutic indications:
Crohn’s Disease
At least 1 in every 323 people in the UK are living with Crohn’s Disease.6
Plaque Psoriasis
Plaque Psoriasis affects almost 2% of the UK population.7
Psoriatic Arthritis
Psoriatic Arthritis affects about 325,000 people, around 0.5% of the UK population.7
Why choose Uzpruvo?
Cost-effective option enabling improved access to ustekinumab treatment1-3
Patient-friendly pre-filled syringe: easy handling, thinner needle than the reference product† & latex-free¥,1,8,9
Equivalent efficacy, safety and immunogenicity to the reference product‡,10
Manufactured in Iceland and packaged in the UK. Supply chain excellence with service levels exceeding 95% throughout 2022*,11
† 29 vs 27-gauge needle of the reference product, Stelara®8; ¥ Plunger stopper made of bromobutyl rubber; ‡ Stelara®; *Supply chain is constantly being optimised and manufacturing location is subject to change
Uzpruvo homecare partners
Uzpruvo has three homecare partners offering flexible delivery and nurse support for your patients:
Lloyds Pharmacy Clinical Homecare
www.lpclinicalhomecare.co.uk
Phone: 0345 263 6123 (England and Wales)
Phone: 0345 263 6135 (Northern Ireland and Scotland)
Uzpruvo therapeutic indications1
Always read the Summary of Product Characteristics (SmPC) before administration.
Plaque psoriasis:1
Adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or psoralen and ultraviolet A (PUVA).1
Paediatric plaque psoriasis:1
Uzpruvo is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.1
Psoriatic arthritis:1
Adult patients with active psoriatic arthritis, alone or in combination with MTX, when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.1
Crohn’s disease:1
Adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, or lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor.1
Contraindications1
Hypersensitivity to the active substance or to any of the excipients. Clinically important, active infection (e.g. active tuberculosis).
Warnings and Precautions1
Infections: ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. Opportunistic infections including reactivation of tuberculosis, other opportunistic bacterial infections, opportunistic fungal infections, opportunistic viral infections, and parasitic infections have been reported.
Malignancies: immunosuppressants have the potential to increase the risk of malignancy. All patients, in particular those greater than 60 years, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer.
Systemic and respiratory hypersensitivity reactions:
- Systemic, serious hypersensitivity reactions including anaphylaxis and angioedema have occurred.
- Respiratory, allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have been reported.
Cardiovascular events: in patients with psoriasis exposed to ustekinumab cardiovascular events including myocardial infarction and cerebrovascular accident have been observed.
Vaccinations: live viral or live bacterial vaccines should not be given concurrently with Uzpruvo.
Serious skin conditions: in patients with psoriasis, exfoliative dermatitis has been reported. Patients with plaque psoriasis may develop erythrodermic psoriasis.
Lupus-related conditions: lupus-related conditions have been reported.
Uzpruvo Healthcare Professional and Patient Support
We understand that information to support you and your patients on their treatment journey is essential to their treatment success. We have developed a range of resources to support you and your patient through the injection process and help your patients understand more about their treatment.
Uzpruvo HCP Leave Piece
Uzpruvo Nurse Guide
Uzpruvo HCP Homecare Implementation Guide
Uzpruvo Patient Guide (Crohn’s disease)
Uzpruvo Patient Guide (psoriatic arthritis)
Uzpruvo Patient Guide (plaque psoriasis)
Uzpruvo Patient Video
Uzpruvo Patient Website
Uzpruvo Homecare Patient Guide
A Phase III study demonstrated Uzpruvo’s therapeutic equivalence to the reference product10*
In a multicentre, double-blind, 52-week study patients were randomised in a 1:2 ratio to Uzpruvo or the reference product* (RP). At week 16, responsive patients (≥50% improvement in psoriasis area and severity index (PASI)) previously on Uzpruvo continued on Uzpruvo, while those on RP were re-randomized 1:1 to switch to Uzpruvo or stay on RP. The primary endpoint was a percent improvement in PASI from baseline to week 12. Therapeutic equivalence was demonstrated if the confidence interval (CI) for the adjusted difference in means was contained within the equivalence margins; ±10% (90%CI).
Results: Of the 581 patients initially randomised (AVT04:RP, 194:387), 575 completed week 16 and 544 completed end of study visit. The percent PASI improvement for Uzpruvo vs RP was 87.3% vs 86.8% (CI: -2.14%, 3.01%); study met its primary endpoint. Efficacy, safety and pharmacokinetic (PK) profiles were comparable across treatment arms throughout the entire study duration, and the incidence of antibodies to ustekinumab had no clinically meaningful impact.
Conclusion: This study demonstrates the therapeutic equivalence between Uzpruvo and the reference product* in patients with moderate-to-severe chronic PsO, with similar safety and tolerability.
Similar efficacy10
The study primary endpoint was met: the percent improvement in PASI from baseline to Week 12 for Uzpruvo (87.3%) and the reference product* (86.8%) was similar.
Similar immunogenicity10
The incidence of treatment emergent ADAs up to Week 52 did not have any clinically meaningful difference for Uzpruvo and the reference product*, even after changing treatments. NAb frequencies remained consistent over time.
Similar safety profile10
Comparable adverse event profiles for Uzpruvo and the reference product* up to Week 52, even after treatment change.
Similar PK profile10
Similar mean serum ustekinumab concentration-time profiles for Uzpruvo and the reference product*
PASI: Psoriasis Area and Severity Index; ADA: anti-drug antibodies; NAbs: neutralising antibodies; PK: Pharmacokinetic; *Stelara®
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References
- Uzpruvo SmPC. Last accessed: August 2024.
- Cost of Uzpruvo taken from NHS DM+D. Last accessed: August 2024.
- Cost of reference product (Stelara) taken from NHS DM+D. Last accessed: August 2024.
- Miller FW et al. Current Opinion in Immunology. 2023;80:102266;
- The Lancet. Incidence, prevalence, and co-occurrence of autoimmune disorders over time and by age, sex, and socioeconomic status: a population-based cohort study of 22 million individuals in the UK. Last accessed: August 2024.
- Crohn’s & Colitis UK. Crohn’s Disease, Your Guide. Last accessed: August 2024.
- The Psoriasis and Psoriatic Arthritis Alliance. Psoriasis and psoriatic arthritis statistics. Last accessed: August 2024.
- Stelara package insert. Last accessed: August 2024.
- Jaber A, Bozzato GB, Vedrine L, Prais WA, Berube J, Laurent PE. A novel needle for subcutaneous injection of interferon beta-1a: effect on pain in volunteers and satisfaction in patients with multiple sclerosis. BMC Neurol. 2008 Oct 10;8:38. doi: 10.1186/1471-2377-8-38. PMID: 18845005; PMCID: PMC2577094. Last accessed: August 2024.
- Feldman SR, Reznichenko N, Berti F, Duijzings P, Ruffieux R, Otto H, Haliduola HN, Leutz S, Stroissnig H. Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):759-771. doi: 10.1080/14712598.2023.2235263. Epub 2023 Jul 12. PMID: 37435850. Last accessed: August 2024.
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STADA sustains strong momentum with double-digit sales and profit growth in 2022. Published 06/03/2023. Last accessed: August 2024.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Thornton and Ross Limited by emailing thorntonross@medinformation.co.uk or by calling 01484 848164.
UK-MULT-122fa | August 2024