JOHNSON & JOHNSON The European Commission Approves Expanded Use of Janssen's STELARA (ustekinumab) for the Treatment of Paediatric Patients With Moderate to Severe Plaque Psoriasis
Beerse,
In one third of the 14 million cases in
'This latest EC approval is a significant milestone for young children struggling to cope with the symptoms of psoriasis,' said
In the study, 44 patients (aged 6-11 years) from nine countries were enrolled and treated with at least one injection of ustekinumab. At baseline, the mean duration of psoriasis was 3.5 (standard deviation 2.49) years. At week 12, subjects treated with ustekinumab showed clinically meaningful improvements in their psoriasis and HrQOL. At week 12, 77.3% (95% confidence interval [CI]: 62.2%, 88.5%) achieved PGA 0/1, 84.1% (95% CI: 69.9%, 93.4%) achieved PASI 75, and 63.6% (95% CI: 47.8%, 77.6%) achieved PASI 90. The mean change from baseline in CDLQI was -6.3 (95% CI: -8.29; -4.28, lower is better). All patients were followed for up to 52 weeks after the first administration of ustekinumab. Improvements in PGA 0/1, PASI 75, PASI 90 and CDLQI were maintained through to week 52 (75.6%, 87.7%, 70.7%, and 58.3%, respectively).6,7
Safety data from CADMUS Jr were consistent with the known safety profiles reflected in respective current prescribing information labels and ustekinumab was generally well-tolerated by paediatric patients with plaque psoriasis. Overall, 34 patients had more than one adverse event (AE; [77.3%]) and three had more than one serious AE (6.8%). One patient had a serious infection (mononucleosis), 29 had infections (65.9%), and 12 had infections requiring treatment (27.3%). In general, the AEs and other safety data reported up to one year in two paediatric patient studies (CADMUS and CADMUS Jr) were similar to those seen in previous studies in adults with plaque psoriasis.6,7,[6],[7],[8]
This marketing authorisation follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the
About the CADMUS programme
CADMUS Jr is a Phase 3, multicentre, open-label study including 44 participants aged 6-11 years, which was initiated following the successful completion of the CADMUS study involving patients aged 12-17 years. The study included a single arm in which patients received one injection of ustekinumab subcutaneously on weeks 0, 4, 16, 28 and 40. The dose of ustekinumab administered was dependant on the weight of the participant, as follows: Participants weighing 100 kg received ustekinumab 90 mg. Following completion of the week 52 visit, participants who had a beneficial response from ustekinumab treatment, as determined by the investigator, and who had not yet reached the age of 12 years or older in countries where marketing authorisation for ustekinumab has been granted for the treatment of psoriasis in adolescent participants (12-17 years), and who were willing to continue ustekinumab treatment, could enter the long-term extension (LTE) period (from week 56 through week 264) of the study. The study primarily concluded in
CADMUS is a Phase 3, multicentre, randomised, double-blind study including 110 participants aged 12-17 years. The study included three arms: the ustekinumab standard dosage arm, the ustekinumab half-standard dosage arm, and the placebo arm. In the standard dosage arm (0.75 mg/kg, 45 mg, or 90 mg [based on body weight]), patients received one injection of ustekinumab subcutaneously on weeks 0, 4, 16, 28 and 40, and received one placebo injection subcutaneously on weeks 0 and 4 or week 12. In the half-standard dosage arm (0.375 mg/kg, 22.5 mg, or 45 mg [based on body weight]), patients received one injection of ustekinumab subcutaneously on weeks 0, 4, 16, 28 and 40, and received one placebo injection subcutaneously on weeks 0 and 4 or week 12. In the placebo arm, patients received one placebo injection subcutaneously on weeks 0 and 4 or week 12, followed by ustekinumab at half-standard or standard dosage at weeks 12, 16, 28, and 40. The study concluded in January 2014.9
The primary endpoint of both studies was the percentage of participants achieving a PGA score of Cleared (0) or Minimal (1) at week 12. Safety data from CADMUS Jr and CADMUS were consistent with the known safety profiles reflected in respective current prescribing information labels, and ustekinumab was generally well-tolerated by paediatric patients with plaque psoriasis. Overall for CADMUS Jr, 34 patients had more than one AE (77.3%) and three had more than one serious AE (6.8%). One patient had a serious infection (mononucleosis), 29 had infections (65.9%), and 12 had infections requiring treatment (27.3%). For CADMUS, 90 patients (81.8%) reported an AE, of which 34.5% reported nasopharyngitis, 12.7% reported an upper respiratory tract infection, and 8.2% reported pharyngitis. 74 (67.3%) reported an infection and two serious infections were reported (pyelonephritis and ear infection). In general, the AEs and other safety data reported up to 1 year in both paediatric patient studies were similar to those seen in studies in adults with plaque psoriasis.6,7,10,11,12,13
About STELARA (ustekinumab)6
In the
Ustekinumab is 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 therapy has been inadequate. 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. Moreover, 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.
The Janssen Pharmaceutical Companies of
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Cautions concerning forward-looking statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding development and potential availability in the EU of 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
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