Boehringer Ingelheim’s investigational biologic cleared skin better, faster and for longer than ustekinumab in phase II psoriasis study
New results from a Phase II head-to-head psoriasis study showed superior efficacy of Boehringer Ingelheim’s investigational biologic compound BI 655066*, over ustekinumab. After nine months, 69 percent of patients with moderate-to-severe plaque psoriasis maintained clear or almost clear skin (PASI 90) with BI 655066 in the higher dose group compared to 30 percent of patients on ustekinumab.1 Patients also achieved this skin clearance significantly faster (approximately eight weeks versus approximately 16 weeks) and for more than two months longer (≥ 32 weeks versus 24 weeks) than those on ustekinumab. In addition, completely clear skin (PASI 100) was maintained after nine months in nearly triple the percentage of patients on BI 655066* compared with ustekinumab (43 percent versus 15 percent).1
"These results are striking. They further strengthen our understanding of the potential skin improvement that can be achieved with BI 655066, in moderate-to-severe plaque psoriasis. We saw a third more patients achieve clearer skin in a short time period. And this clearance was maintained longer compared to the commonly used treatment ustekinumab,” commented Kim A. Papp, MD, PhD, President of Probity Medical Research, Waterloo, Ontario, Canada. “Achieving clear skin quickly and maintaining clearance is an important goal for patients that have to deal with the daily impact of psoriasis.”
These meaningful 24-week findings from a Phase II study in psoriasis were presented today in an oral presentation by Dr Kim A. Papp at the 24th European Academy of Dermatology and Venereology (EADV) congress in Copenhagen.
The study (NCT02054481) investigated the efficacy and safety of BI 655066 versus ustekinumab in 166 patients.1 These data build on Phase II data presented earlier this year at the Annual Meeting of the American Academy of Dermatology (AAD). Primary endpoint results showed nearly double the percentage of patients with moderate-to-severe plaque psoriasis achieved clear or almost clear skin (PASI 90) after 12 weeks of treatment with BI 655066, compared to ustekinumab (77.1 percent versus 40 percent of patients). The new data further demonstrate that BI 655066 has similar safety and tolerability to ustekinumab, regardless of dose, with no serious drug-related side-effects.1 The most common side effects were runny nose, sore throat, and headache.1
“The results are an exciting milestone in Boehringer Ingelheim’s growing immunology pipeline. These Phase II study results represent a major step towards our vision of transforming the treatment of immune diseases and the patients affected by it,” said Dr. Steven Padula, Therapeutic Area Head Medicine Immunology at Boehringer Ingelheim. “We look forward to continued research and are currently planning multiple Phase III studies.”
Additional trial information
The data discussed in this press release represent results for BI 655066 180mg (n=42) injection under the skin, delivered at weeks zero, four and 16.
The BI 655066 90mg (n=41) dose also showed superior efficacy, onset and duration of action over ustekinumab after nine months.1
- More patients with moderate-to-severe psoriasis maintained almost clear skin (PASI 90) with BI 655066 compared to those on ustekinumab (81 percent versus 30 percent)1
- More patients on BI 655066 had completely clear skin (PASI 100) compared with ustekinumab (54 percent versus 15 percent)1
An exploratory single dose of BI 655066 18mg (n=43) was also studied.1
Ustekinumab 45mg/90mg (n=40) was delivered as an injection under the skin at weeks zero, four and 16.
Registered media can view the abstract online.
*BI 655066 is not approved by regulatory authorities and its safety and efficacy is being investigated.
For additional information, click here to view the Facts about Psoriasis fact sheet.
If you are attending the EADV congress, visit us at the Boehringer Ingelheim booth, number 147.
For notes to editors and references please visit:
Media + PR
Phone: +49 (6132) 77 8271
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
AstraZeneca’s Calquence (acalabrutinib) Shows Potential in Chronic Lymphocytic Leukaemia Trials10.12.2017 22:45 | Pressemelding
AstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, today presented results from the Phase Ib/II ACE-CL-003 clinical trial (Abstract #432) and updated results from the Phase I/II ACE-CL-001 (Abstract #498) clinical trial that are testing Calquence (acalabrutinib) alone and in combination for the treatment of chronic lymphocytic leukaemia (CLL) in multiple treatment settings. The findings were presented during two oral sessions at the 59th American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “These data add to the growing body of evidence that supports the potential of Calquence in the treatment of chronic lymphocytic leukaemia, a life-threatening disease that affects tens of thousands of people aroun
Celgene Corporation and bluebird bio Announce Updated Results from Ongoing Multicenter Phase 1 Study of bb2121 Anti-BCMA CAR T Cell Therapy in Patients with Late Stage Relapsed/Refractory Multiple Myeloma at ASH Annual Meeting10.12.2017 15:30 | Pressemelding
Celgene Corporation (NASDAQ: CELG) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that updated results from the ongoing CRB-401 Phase 1 clinical study of bb2121, an investigational anti-B-cell maturation antigen (BCMA) CAR T cell therapy, in 21 patients with late-stage relapsed/refractory multiple myeloma will be presented in an oral presentation at the American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia. The objective of this Phase 1 dose-escalation study is to evaluate safety and efficacy of bb2121 and determine a recommended Phase 2 dose. “Celgene has a longstanding commitment to patients with multiple myeloma through our extensive research efforts in this deadly blood cancer,” said Nadim Ahmed, President, Hematology and Oncology for Celgene. “Looking ahead, we see BCMA as an important target in this disease and we believe bb2121 has the potenti
Kite Announces Long-Term Data From Pivotal ZUMA-1 Study of Yescarta™ (Axicabtagene Ciloleucel) in Patients With Refractory Large B-cell Lymphoma10.12.2017 15:30 | Pressemelding
Kite, a Gilead Company (Nasdaq: GILD), announced long-term follow-up data from the pivotal ZUMA-1 study of Yescarta™ (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. With a minimum follow-up of one year after a single infusion of Yescarta (median follow-up of 15.4 months), 42 percent of patients continued to respond to therapy, including 40 percent with a complete remission. Detailed results from this updated analysis were simultaneously presented at the Annual Meeting of the American Society of Hematology (ASH) in Atlanta and published in The New England Journal of Medicine. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171210005072/en/ Yescarta is the first chimeric antigen receptor T (CAR T) cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult
Takeda and Seattle Genetics to Present Positive Data from Phase 3 ECHELON-1 Clinical Trial Evaluating ADCETRIS® (brentuximab vedotin) in Frontline Advanced Hodgkin Lymphoma10.12.2017 13:00 | Pressemelding
Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (NASDAQ: SGEN) today announced that data from the Phase 3 ECHELON-1 clinical trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in untreated advanced classical Hodgkin lymphoma will be presented in the Plenary Scientific Session at the 59th American Society of Hematology (ASH) annual meeting on Sunday, December 10, 2017. The data were also simultaneously published online in the New England Journal of Medicine and will be published in the print edition on January 25, 2017. Topline data were reported in June 2017 demonstrating the ECHELON-1 trial met its primary endpoint of a statistically significant improvement in modified progression-free survival (modified PFS) per Independent Review Facility (IRF) versus the control arm. ADCETRIS is an antibody-drug con
AstraZeneca’s Calquence (acalabrutinib) Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma Trial9.12.2017 18:00 | Pressemelding
AstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, today presented results from the open-label, single-arm Phase II ACE-LY-004 clinical trial, which served as the basis for the recent US Food and Drug Administration (FDA) accelerated approval of Calquence (acalabrutinib). The findings were presented for the first time during an oral session at the 59th American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA and demonstrate the safety profile and efficacy of acalabrutinib in the management of previously-treated mantle cell lymphoma (MCL). Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The results presented for the first time to the medical community highlight the potential of Calquence as a treatment for people with relapsed or refractory mantle cell l
Sustained Benefit in Patients with Relapsed/Refractory Mantle Cell Lymphoma Demonstrated by 3.5 Year Follow-up Data of Imbruvica®▼(ibrutinib)9.12.2017 17:19 | Pressemelding
Today, Janssen-Cilag International NV (“Janssen”) announced results of a pooled analysis of relapsed/refractory (r/r) mantle cell lymphoma (MCL) patients treated with Imbruvica® (ibrutinib). The extended follow-up data demonstrated that patients treated with ibrutinib earlier (at first relapse) experienced the best clinical outcomes, both in terms of efficacy and tolerability. These data (abstract #151) were presented in an oral presentation at the 59th Annual American Society of Hematology (ASH) Meeting and Exposition in Atlanta, GA.1,2 Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. “Data from this large clinical trial data set with extended follow-up support the early use of ibrutinib in patients with relapsed or refractory mantle cell lymphoma,” said Simo
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom