Graduate

STUDIES
New data shows Stelara ® (ustekinumab) maintained clinical response and remission
after two years of treatment in patients with moderate to severe Crohn’s disease
Janssen-Cilag International NV (“Janssen”) has announced new two-year data from the ongoing IM-UNITI long-term extension (LTE)
study evaluating the efficacy and safety of subcutaneous (SC) STELARA ® (ustekinumab) in patients with moderate to severe Crohn’s
disease. The data presented at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO) showed that treatment
with ustekinumab maintained clinical response and remission for up to two years with no new safety signals observed.
Of the 1,281 patients enrolled in the maintenance study, 397 patients who achieved a response to ustekinumab at week 8,
following an induction phase, were randomised to receive SC ustekinumab 90mg every 8 weeks (Q8W) or every 12 weeks (Q12W),
or placebo during a maintenance (0–44 week) period, before entering the LTE (44-252 week) period. A one-time dose adjustment to
ustekinumab 90mg Q8W was permitted in patients in the randomised group who met loss of response criteria between weeks 8-32.
Clinical efficacy data was collected every 12 weeks and safety data was collected every four weeks from the end of the maintenance
trial (week 44) until the maintenance study was unblinded and then at Q8W or Q12W dosing visits during the LTE period; data at
week 92 is reported here.
Among randomised patients who entered the LTE period and continued to receive ustekinumab through week 96, 79.2% of
patients receiving ustekinumab Q12W and 87.1% of patients receiving ustekinumab Q8W were in remission, while 90.9% of patients
and 94.3% of patients showed clinical response at week 92, respectively. Among all ustekinumab-treated patients who continued to
receive ustekinumab through week 96, remission and response rates at week 92 were 70.7% and 84.7%, respectively (as observed).
Safety event rates per 100 years of follow up were comparable in ustekinukab-treated patients compared to placebo-treated
patients from week 44 through to week 96. Among all ustekinumab-treated patients, there were two deaths (sudden death,
asphyxia). There were two non-NMSC (non-melanoma skin cancer) malignancies reported between weeks 44 and 96, a seminoma in
a ustekinumab-treated patient and a papillary thyroid cancer in a placebo-only-treated patient.
Irish patients first in the world to receive promising drug combination as part
of Blood Cancer Network Ireland Clinical Trial
Irish patients with the blood cancer ‘multiple myeloma’ are the first patients worldwide to take part in a new drug trial to develop
more effective treatment for the cancer.
Multiple myeloma is a blood cancer arising from a type of white blood cell called a plasma cell. Each year in Ireland,
approximately 250 people are diagnosed with the cancer and 170 succumb to the disease.
This innovative Phase 1 clinical trial, being led by researchers at NUI Galway, will investigate for the first time whether the
addition of a new multiple myeloma treatment, Daratumumab (DARA), to a standard care chemotherapy containing the drugs
Cyclophosphamide and Bortezomib (CyBorD), is beneficial for treating newly diagnosed patients. DARA by itself is a very promising
new therapy for this particular cancer and has recently been approved for treating relapsed patients. This new trial is the first
study worldwide to combine DARA with Cyclophosphamide and will determine whether this combination results in a more
effective treatment.
Blood Cancer Network Ireland (BCNI) has already recruited the first six patients at University Hospital Galway and Cork
University Hospital and the study will soon be extended to BCNI centres in Dublin, thereby giving multiple myeloma patients
nationwide access to the trial. BCNI is a €2.7 million cancer research and clinical trials initiative funded by the Irish Cancer Society
and Science Foundation Ireland, which brings together clinicians, scientists and population health experts across Galway, Cork and
Dublin with a shared interest in blood cancer research.
Notably, this clinical trial is the first home-grown (investigator initiated) trial to be conducted by BCNI. It is the culmination of
collaborative research efforts between BCNI scientists and Janssen pharmaceuticals which show that Cyclophosphamide treatment
can potentially make DARA more effective. It represents a bench-to-bedside approach where scientific insights from the laboratory
are applied to developing new and improved ways to treat patients.
This is the first cancer clinical trial to be sponsored by NUI Galway on behalf of BCNI and it demonstrates the University’s
commitment to supporting clinical cancer research. Irish patients on this trial will receive additional benefits including state of the
art monitoring and access to this new treatment free-of-charge.
The past two decades have seen major advances in the treatment of multiple myeloma with approval of several new treatments
resulting in a doubling in survival over this period. Carefully conducted clinical trials based on bench-to-bedside research have
been critical for these developments. This trial exemplifies this approach and is an important contribution by Irish researchers and
patients to the global fight against multiple myeloma.
For more information on the study, please visit www.bloodcancers.ie or www.clinicaltrials.gov (search: NCT02955810).
IPUREVIEW APRIL 2017 47