HIGH WYCOMBE, England, September 14, 2015 /PRNewswire/ --
For trade and medical media only
Launch of ustekinumab in adolescent psoriasis provides a new therapeutic option for plaque psoriasis patients aged 12 and older in the UK, for whom limited approved treatment options are available
Janssen-Cilag Ltd. announced today that STELARA® (ustekinumab) is now available in the UK for the treatment of moderate-to-severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. The launch follows the European Commission approval in June 2015 and the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in May 2015, recommending the use of ustekinumab for this indication.
Plaque psoriasis is a chronic autoimmune disease that affects from 0.5 to 2 percent of the general population during childhood and adolescence. Plaque psoriasis is the most common type of psoriasis and classically presents patches of thick, red or inflamed skin covered with silvery scales known as plaques. The prevalence of psoriasis in those aged between 10 and 19 years is around 1.4% which suggests that around 40,000 children and adolescents in this age group are affected by psoriasis in the UK.
In June 2015, the European Commission (EC) provided approval based on data from the CADMUS study, a Phase 3, randomised, double-blind, placebo-controlled, multicentre trial. Patients aged 12-17 with moderate-to-severe plaque psoriasis were randomised 1:1:1 to receive subcutaneous placebo, ustekinumab standard dosing or ustekinumab half standard dosing at weeks 0 and 4 followed by every 12 week dosing. Ustekinumab dosing tiers were determined by body weight and intended to achieve exposure to therapy comparable to adults. Patients receiving placebo crossed over to receive the ustekinumab standard dose or half standard dose at weeks 12 and 16; all patients continued with maintenance dosing every 12 weeks through week 40.
"Ustekinumab is an innovative biologic which, we know from recent trials, can positively impact the lives of younger people with psoriasis. Ustekinumab has been used in adults for a number of years now and we know it has been beneficial in the management of adult psoriasis, so to have the full data for the use of this medication in younger people is a great step forwards," commented Dr Anthony Bewley FRCP, Consultant Dermatologist at Whipps Cross University Hospital & Royal London Hospital, and Investigator in the CADMUS study.
The primary endpoint was the proportion of patients who achieved a Physician Global Assessment (PGA) score of cleared (0) or minimal (1) at week 12. Secondary endpoints included Psoriasis Area Severity Index (PASI) 75, PASI 90, change from baseline in Children's Dermatology Life Quality Index (CDLQI), and change from baseline in the total scale score of PedsQL (Paediatric Quality of Life Inventory)at week 12. Final efficacy and safety evaluations were made at weeks 52 and 60, respectively.
At week 12, patients treated with the ustekinumab standard dose showed significantly greater improvement in their psoriasis and health-related quality of life compared with placebo. The proportion of patients achieving a PGA score of either 0 or 1 was significantly greater in both the half standard dose (67.6%) and standard dose (69.4%) groups versus placebo (5.4%; p<0.001). Beyond week 12, efficacy was generally higher and better sustained in the standard dose group compared with half standard dose group. Improvements in PGA, PASI, CDLQI and PedsQL were maintained through week 52 in the standard dose group compared with the half standard dose group; however, no formal statistical comparisons were performed.
Through week 12, the proportion of patients with at least one adverse event was comparable between the treatment arms: 47.9 percent in the combined ustekinumab cohort vs 56.8 percent for placebo-treated patients. In the ustekinumab-treated patients, one patient in the half standard dose group reported a serious adverse event through week 12. The safety profiles of the standard dose and half standard dose groups were comparable.
Through week 40, all 110 patients received ≥ one injection of ustekinumab; among these, 81.8% reported an adverse event through week 60, with 5.5 percent reporting a serious adverse event. Malignancies, opportunistic infections and anaphylactic reactions did not occur. The safety of ustekinumab has been studied in a phase 3 study of 110 patients from 12 to 17 years of age for up to 60 weeks. In this study, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Dr Rozlyn Bekker, Medical Director at Janssen UK commented: "The CADMUS study has shown that ustekinumab is an efficacious treatment option that can significantly improve psoriasis symptoms and lessen its impact on quality of life in young people aged 12 and over. This new paediatric indication is a great step forwards for younger patients, families and clinicians."
Notes to Editor
Psoriasis, a chronic, immune-mediated disease that results in the overproduction of skin cells, affects 125 million people worldwide, including up to 1.8 million people in the UK and nearly 14 million Europeans.,,,,, Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales known as plaques. These plaques can crack and bleed, and may occur anywhere on the body. The disease symptoms can range from mild, to moderate, to severe and disabling. It is estimated that nearly three percent of the world's population is living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe. Although the disease can present at any age, approximately one-third of people develop psoriasis before the age of 18.
About ustekinumab in paediatric patients (CADMUS study),
CADMUS, a Phase 3, randomised, double-blind, placebo-controlled, parallel, multicentre trial, evaluated the efficacy and safety of ustekinumab in paediatric patients aged 12 to 17 years with moderate-to-severe plaque psoriasis. Patients (N=110) had a diagnosis of plaque-type psoriasis for at least 6 months prior to first study agent administration and had a moderate-to-severe disease defined by a PASI score greater than or equal to 12, a Physician's Global Assessment (PGA) score greater than or equal to 3 and body surface area (BSA) involvement of at least 10 percent. In addition, patients were inadequately controlled with topical therapy or were candidates for systemic/phototherapy. Approximately 60% of the patients had prior exposure to conventional systemic therapy or phototherapy. Approximately 11% of the patients had prior exposure to biologics.
Ustekinumab, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of moderate-to-severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including:
- methotrexate (MTX) or
- psoralen plus ultraviolet A (PUVA).
Ustekinumab is indicated for the treatment of moderate-to-severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. The safety and efficacy of ustekinumab in children less than 12 years have not yet been established.
Ustekinumab is also approved alone or in combination with MTX, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.
The Janssen Pharmaceutical Companies maintain exclusive worldwide marketing rights to ustekinumab, which is currently approved for the treatment of moderate-to-severe plaque psoriasis in 84 countries and psoriatic arthritis in 55 countries.
Important safety information (EU)
SPECIAL WARNINGS & PRECAUTIONS: Infections: Potential to increase risk of infections and reactivate latent infections. Exercise caution in patients with a chronic infection or history of recurrent infection, particularly TB. Patients should be evaluated for tuberculosis and treated for latent TB prior to initiation of ustekinumab. Also, consider anti-tuberculosis therapy prior to initiation of ustekinumab in patients with past history of latent or active tuberculosis. Patients should seek medical advice if signs or symptoms suggestive of an infection occur. If a serious infection develops, they should be closely monitored and ustekinumab should not be administered until infection resolves. Malignancies: Potential to increase the risk of malignancy. No studies have been conducted in patients with a history of malignancy or in those who continue to receive ustekinumab after being diagnosed with a malignancy. Exercise caution when considering ustekinumab in these patients. Monitoring for the appearance of non-melanoma skin cancer recommended, in particular for patients greater than 60 years of age, or with a medical history of prolonged immunosuppressant therapy or a history of PUVA treatment. Hypersensitivity reactions: Serious hypersensitivity reactions (anaphylaxis and angioedema) reported, in some cases several days after treatment. If these occur, institute appropriate therapy and discontinue use of ustekinumab. Vaccinations: Patients receiving ustekinumab should not receive concurrent live viral or live bacterial vaccines such as BCG. Before live viral or live bacterial vaccination, treatment with ustekinumab should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination. Patients receiving ustekinumab may receive concurrent inactivated or non-live vaccinations. Concomitant immunosuppressive therapy: Exercise caution, including when changing immunosuppressive biologic agents. In psoriasis studies, the safety and efficacy of ustekinumab in combination with other immunosuppressants, including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. Immunotherapy: Not known whether ustekinumab affects allergy immunotherapy. Serious skin conditions: In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment. Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptoms that may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course of their disease. If these symptoms occur, appropriate therapy should be instituted. ustekinumab should be discontinued if a drug reaction is suspected. Latex sensitivity: Needle cover contains natural rubber (latex), may cause allergic reactions. Elderly Patients > 65years: Use caution when treating elderly patients.
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