Breaking News
October 16, 2018 - Global study finds youngest in class more likely to be diagnosed with ADHD
October 16, 2018 - Researchers sequence two selfish genes in the fungus Neurospora intermedia
October 16, 2018 - Survey results highlight the need for better communication between patients and HCPs about bacterial vaginosis
October 16, 2018 - Researchers develop fibrin-targeting immunotherapy to protect against neurodegeneration
October 16, 2018 - Researchers create open access database on healthy immunity
October 16, 2018 - Rice University chemist wins big award to study small surfaces
October 16, 2018 - Study finds 43% drop in stroke rate
October 16, 2018 - Researchers identify basic relationships of cell cycle and cellular senescence in the placenta
October 16, 2018 - Obesity Doubles Odds for Colon Cancer in Younger Women
October 16, 2018 - Adults with ADHD not constrained in creativity
October 16, 2018 - Raising visibility for people and students with chronic illness and disability
October 16, 2018 - Allele awarded NIH grant to develop nanoantibody therapies for treatment of sepsis
October 16, 2018 - Only 59% of young adults undergoing surgery are fluid responsive
October 16, 2018 - Research points to potential new treatment for hearing loss
October 16, 2018 - MDI Biological Laboratory receives $1.2 million SEPA grant to promote data literacy
October 16, 2018 - Vast majority of dementia cases may arise from spontaneous genetic errors
October 16, 2018 - New project aims to deliver fast, effective treatment for autoimmune rheumatic diseases
October 16, 2018 - Study identifies molecular switch that controls fate of milk-producing breast cells
October 16, 2018 - Research shows diet has little influence on precursor to gout
October 16, 2018 - “Without Dr. Shumway doing his miracle work, three generations would not be here”: A Stanford heart transplant patient’s story
October 16, 2018 - Non-invasive brain stimulation sheds light on neurobiology underlying implicit bias
October 16, 2018 - Researchers demonstrate integrated technique to control production of cell therapeutics
October 16, 2018 - Breast tomosynthesis detects 34% more tumors than traditional mammography
October 16, 2018 - Rhode Island Hospital, Brown receive $800,000 grant to keep up fight against opioid epidemic
October 16, 2018 - UVA partners with health systems in AVIA network’s Medicaid Transformation Project
October 16, 2018 - Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome
October 16, 2018 - Study reveals early warning signs of heart problems in patients with newly diagnosed lupus
October 16, 2018 - Connecting the dots of Alzheimer’s disease
October 16, 2018 - New publication offers evidence-based content for global breast imaging medical community
October 16, 2018 - ‘EinsteinVision’ that improves hand-eye coordination of surgeons introduced at Harefield Hospital
October 16, 2018 - WRAIR clinical study evaluates safety and immunogenicity of Marburg vaccine
October 16, 2018 - Ketamine can be considered as alternative to opioids for short-term pain control in ED
October 16, 2018 - Endurance exercise training beneficially alters gut microbiota composition
October 15, 2018 - FDA Approves Yutiq (fluocinolone acetonide intravitreal implant) for Chronic Non-Infectious Posterior Segment Uveitis
October 15, 2018 - Birthing Options for Full-Term Pregnancy
October 15, 2018 - Stressed, toxic, zombie cells seen for first time in Alzheimer’s
October 15, 2018 - Concussion researchers study head motion in high school football hits | News Center
October 15, 2018 - Neuropsychiatric symptoms related to earliest stages of Alzheimer’s brain pathology
October 15, 2018 - Neck collar device may help protect the brain of female high school soccer players
October 15, 2018 - Research reveals how the inner ear processes speech
October 15, 2018 - Many parents still skeptical about safety and effectiveness of flu shot, survey finds
October 15, 2018 - Payer Policies May Discourage Non-Pharma Tx for Low Back Pain
October 15, 2018 - Exercise may delay cognitive decline in people with rare Alzheimer’s disease
October 15, 2018 - Researchers modify CRISPR to reorganize genome | News Center
October 15, 2018 - Innovative brain tumor operation set to tailor to patients’ needs
October 15, 2018 - Findings offer new insight into early changes that occur during AD pathology
October 15, 2018 - Neurons regulating reproductive hormone release have different activity in epileptic mice
October 15, 2018 - More parents are concerned about taking babies swimming in public pools
October 15, 2018 - Health Tip: Know the Risk Factors for Lower Back Pain
October 15, 2018 - Study shows cigarillo flavors enhanced by high-intensity sweeteners
October 15, 2018 - Study traces hospital-acquired bloodstream infections to patients’ own bodies | News Center
October 15, 2018 - Abnormal vision in childhood can affect development of brain areas responsible for attention
October 15, 2018 - Study highlights need for increased support for alcohol-related liver disease patients
October 15, 2018 - Color-changing contact lens could help doctors to monitor eye disease medications
October 15, 2018 - Tobacco heating products cause less staining to teeth than conventional cigarettes
October 15, 2018 - Young adults who are obese can expect to lose up to 10 years in life expectancy
October 15, 2018 - Scientists uncover how proteins meet on the cell membrane
October 15, 2018 - Affordable housing with supportive social services for senior citizens can reduce hospital use
October 15, 2018 - Schiller Easy Pulse Saves Lives
October 15, 2018 - The latest ECG device from Schiller
October 15, 2018 - Following a Tissue Sample
October 15, 2018 - Prisoners need drug and alcohol treatments but AA programs aren’t the answer
October 15, 2018 - Andrea Califano and Jordan Orange Elected to National Academy of Medicine
October 15, 2018 - The impending risk of African Swine Fever Virus
October 15, 2018 - Breastfeeding reduces the number of antibiotic-resistant bacteria in infant gut
October 15, 2018 - Researchers develop comprehensive molecular atlas of postnatal mouse heart development
October 15, 2018 - ObsEva SA Presents Clinical Data from Phase III IMPLANT 2 Trial of Nolasiban in IVF at the American Society of Reproductive Medicine (ASRM) Annual Meeting
October 15, 2018 - Engineering teratoma-derived fibroblasts to enhance osteogenesis
October 15, 2018 - Lab study shows effectiveness of potential therapy for treatment-resistant hypothyroidism
October 15, 2018 - JCU study firms up association between diet and depression
October 15, 2018 - Researchers to study the use of CRISPR on human liver on-a-chip platform
October 15, 2018 - Sub-concussive impacts not associated with decline in neurocognitive function
October 15, 2018 - Researchers find potential treatment to halt premature labor and birth
October 15, 2018 - As U.S. suicides rates rise, Hispanics show relative immunity
October 15, 2018 - FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys
October 15, 2018 - Photoactive bacteria bait may help in fight against MRSA infections
October 15, 2018 - Increasing vigorous exercise reduces risk factors of type 2 diabetes, cardiovascular disease in children
October 15, 2018 - First-of-its-kind study to test a personalized vaccine in cancer patient
October 15, 2018 - Extension trial assesses benefit of switching from flash monitoring to RT-CGM for hypoglycemia
October 15, 2018 - Half of parents say young children are afraid of doctor’s visits
Risankizumab Meets All Primary Endpoints Reporting Positive Results in Fourth Pivotal Phase 3 Psoriasis Study

Risankizumab Meets All Primary Endpoints Reporting Positive Results in Fourth Pivotal Phase 3 Psoriasis Study

image_pdfDownload PDFimage_print

NORTH CHICAGO, Ill., Dec. 4, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from IMMhance, the fourth pivotal Phase 3 clinical trial evaluating risankizumab (150 mg) for the treatment of patients with moderate to severe plaque psoriasis.1 There were two phases in this study. Results from the first phase showed that after 16 weeks of treatment, risankizumab met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) versus placebo.1 In the second phase of this study, the primary endpoint of sPGA 0/1 at week 52 (one year) was also met.1 The second phase (week 28 through 104) is evaluating the efficacy and safety of continuous therapy with risankizumab versus randomized withdrawal. Subsequently, retreatment is also being evaluated in this ongoing study. Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established. Results from IMMhance through week 16 were presented during an oral presentation at the 8th International Congress of Psoriasis from Gene to Clinic meeting in London on December 2nd.

“These positive results are consistent with the previous data we have seen with risankizumab throughout the pivotal Phase 3 clinical trial program,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “With a significant portion of risankizumab patients achieving high levels of skin clearance, these results add to the data supporting risankizumab’s potential to be an impactful new treatment option for patients living with psoriasis. We look forward to sharing additional data from the pivotal trial program with the scientific community and regulatory authorities as we prepare to move forward with global regulatory submissions.”

Risankizumab is part of a collaboration with Boehringer Ingelheim, with AbbVie leading future development and commercialization of risankizumab globally. Top-line results of the three other risankizumab Phase 3 psoriasis pivotal trials (ultIMMa-1, ultIMMa-2 and IMMvent) were previously announced in October 2017.2-4

At week 16, results from the IMMhance study showed that 73 percent of patients receiving risankizumab achieved PASI 90 compared to 2 percent of patients receiving placebo.1 An sPGA 0/1 was achieved by 84 percent of risankizumab patients compared to 7 percent of placebo patients.1

Results showed that nearly half (47 percent) of patients receiving risankizumab achieved PASI 100 compared to 1 percent of patients receiving placebo.1 Additionally, 46 percent of patients receiving risankizumab achieved an sPGA 0 compared to 1 percent of patients receiving placebo.1 All primary and ranked secondary endpoints achieved p-values of 1

In the second phase of the study (week 28 through week 104), patients originally randomized to risankizumab who achieved sPGA 0/1 at week 28 were re-randomized to risankizumab (maintenance) or placebo (withdrawal).1 Beginning at week 32, any patient who experienced a relapse (defined as an sPGA score of moderate to severe [>3]) was retreated with risankizumab immediately, four weeks later and every 12 weeks thereafter.1

The primary endpoint of the second phase of the study (week 28 through week 104) was sPGA 0/1 at one year (week 52).1 Among the maintenance group, 87 percent of patients maintained sPGA 0/1 at one year compared to 61 percent of patients in the withdrawal group (p-value of 1

“The significant rates of skin clearance achieved at week 16 are very encouraging for patients with moderate to severe plaque psoriasis,” said Andrew Blauvelt, M.D., M.B.A., dermatologist and president of Oregon Medical Research Center and the lead investigator for the study. “These data also indicate that continuous treatment with risankizumab has the potential to deliver better disease improvement for patients over time when compared to withdrawing them from therapy after an initial response.”

The safety profile in IMMhance was consistent with previously reported Phase 3 clinical trials, with no new safety signals detected across the Phase 3 program.1-4 In this study, serious adverse events occurred in 2 percent of patients in the risankizumab group and 8 percent of patients in the placebo group through week 16.1 In the second part of the study until the data was locked, serious adverse events occurred in 6 percent of patients re-randomized to the risankizumab group and 6 percent of patients re-randomized to the placebo group.1 In the second phase of the study, one patient receiving risankizumab had intestinal adenocarcinoma and metastatic hepatic cancer and died on study day 339.1 A second patient treated with risankizumab died on study day 263 due to an unknown cause that was adjudicated as a major adverse cardiovascular event (MACE).1 There were two additional adjudicated MACE cases at the time of database lock.1 One event occurred in the placebo arm in the first phase of the study and the other occurred in the risankizumab arm in the second phase.1 All three patients had a past history of cardiovascular risk factors.1

AbbVie is continuing to evaluate the potential of risankizumab across several immune-mediated conditions.6,7

About the Phase 3 IMMhance study

The IMMhance study is an ongoing Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of risankizumab compared to placebo in adult patients with moderate to severe plaque psoriasis. In the first phase, patients were randomized 4:1 to risankizumab (150 mg), given as a subcutaneous injection at baseline, 4 weeks later and every 12 weeks thereafter, or placebo. The co-primary endpoints were achievement of at least a 90 percent improvement in the PASI score (PASI 90) and achievement of an sPGA 0/1 at week 16 compared to placebo. Patients who were originally randomized to placebo switched to risankizumab at week 16.

In the second phase of this study (week 28 through week 104), patients originally randomized to risankizumab who achieved sPGA 0/1 at week 28 were re-randomized to risankizumab (maintenance) or placebo (withdrawal). Beginning at week 32, any patient who experienced a relapse (defined as an sPGA moderate to severe [>3]) was retreated with risankizumab immediately, four weeks later and every 12 weeks thereafter. The primary endpoint from week 28 through week 104 of the study was sPGA 0/1 at one year. This Phase 3 study has been conducted in cooperation between AbbVie and Boehringer Ingelheim. The trial is ongoing and will evaluate patients up to 104 weeks. More information on this trial can be found at www.clinicaltrials.gov (NCT02672852).

Overview of the Risankizumab Phase 3 Psoriasis Program

The global risankizumab Phase 3 psoriasis program evaluates more than 2,000 patients with moderate to severe plaque psoriasis in four pivotal studies. The studies include assessments of efficacy, safety and tolerability of risankizumab. Key measures of efficacy include measures of disease activity and skin clearance, including PASI 90, PASI 100 and sPGA 0/1, as well as long-term clinical outcomes. More information on this program can be found at www.clinicaltrials.gov (NCT02672852, NCT02694523, NCT02684370, NCT02684357).

Longer term safety, through 1.5 years in the first patients who enrolled, was evaluated for patients initially randomized to risankizumab (150 mg) or those who switched from placebo to risankizumab (n=1,590) and those patients randomized to ustekinumab (n=199). Overall rates of adverse events per 100 patient-years (PY) were 245.6 with risankizumab compared to 281.0 with ustekinumab through week 52.1 Serious adverse events were 9.8/100PY (risankizumab) compared with 10.9/100PY (ustekinumab); serious infections were 1.6/100PY (risankizumab) compared with 2.5/100PY (ustekinumab); MACE were 0.5/100PY (risankizumab) compared with 0.0/100PY (ustekinumab); any malignancy was 1.5/100PY (risankizumab) compared with 0.5/100PY (ustekinumab); deaths were 0.3/100PY (risankizumab) compared with 0.0/100PY (ustekinumab).1

About the Phase 3 ultIMMa-1 and ultIMMa-2 studies

ultIMMa-1 and ultIMMa-2 are replicate Phase 3, randomized, double-blind, double-dummy, placebo- and active-controlled studies designed to evaluate the safety and efficacy of risankizumab compared to placebo or ustekinumab in adult patients with moderate to severe plaque psoriasis. The active comparator used for these studies was sourced from the European Union.

About the Phase 3 IMMvent study

The IMMvent study is a Phase 3 randomized, double-blind, double-dummy, active-controlled study designed to evaluate the safety and efficacy of risankizumab compared to adalimumab in adult patients with moderate to severe plaque psoriasis.

About Risankizumab

Risankizumab is an investigational compound that is designed to selectively block IL-23 by binding to its p19 subunit.5 IL-23, a key cytokine involved in inflammatory processes, is thought to be linked to a number of immune-mediated diseases.8 Phase 3 trials of risankizumab in psoriasis are ongoing, and it is also being investigated to treat Crohn’s disease and psoriatic arthritis.6,7 Future trials are planned to investigate risankizumab in ulcerative colitis.

Risankizumab is not approved by regulatory authorities. Safety and efficacy have not been established.

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” in AbbVie’s 2016 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

REFERENCES

1 AbbVie. Data on File, ABVRRTI65374.
2 AbbVie. Data on File, RRTI65191.
3 AbbVie. Data on File, RRTI65192.
4 AbbVie. Data on File, RRTI65055.
5 Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. NEJM. 2017.
6 A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn’s Disease. Clinicaltrials.gov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128?cond=RISANKIZUMAB&draw=3&rank=15. Accessed December 1, 2017.
7 BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Clinicaltrials.gov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02719171?cond=RISANKIZUMAB&draw=3&rank=17. Accessed December 1, 2017.
8 Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
9 HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Last updated March 31, 2017. Accessed December 1, 2017.

SOURCE AbbVie

Posted: December 2017

Tagged with:

About author

Related Articles