Advertisement

Topics

Ixekizumab (Taltz) - Biotech, Pharma and Life Science Channel

23:06 EDT 24th April 2018 | BioPortfolio

Ixekizumab (Taltz) is a humanised IgG4 monoclonal antibody that selectively binds with high affinity to the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.iii IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses, and elevated levels of IL-17A have been implicated in the pathogenesis of a variety of autoimmune diseases such as psoriasis.iii  Neutralisation of IL-17A by ixekizumab inhibits these pro-inflammatory actions.iii

Ixekizumab is administered by subcutaneous injection, either via auto-injector or prefilled syringe.iii

In UNCOVER-1 the results show that when treated every two weeks with ixekizumab for 12 weeks following a starting dose, approximately 9 of 10 patients achieved a PASI 75 score.iiiIn both UNCOVER-2 and UNCOVER-3 etanercept was used as an active comparator. The results show that approximately 9 of 10 patients treated with ixekizumab every two weeks achieved a PASI 75 score at week 12, and approximately 8 of 10 patients achieved clear or almost clear skin as defined by sPGA 0 or 1 respectively.iii,

Numerous secondary end points were also collected from the UNCOVER series of trials, including higher levels of clearance, (PASI 90, 100 and sPGA 0). The impact of psoriasis on patient's lives was assessed using patient reported outcome measures, including the DLQI. Across UNCOVER-1 and UNCOVER 2&3, 35.3 percent and 39 percent of patients, respectively achieved PASI 100 (clear skin) after 12 weeks of treatment with ixekizumab.iii

The approved dosing regimen for ixekizumab is a 160-mg starting dose by subcutaneous injection (two 80-mg injections) at Week 0, followed by 80 mg (one injection) every two weeks through 12 weeks, then maintenance dosing of 80 mg (one injection) every four weeks.iii

Lilly received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on February 25, 2016.v

Safety information

The very common (≥1/10 patients) adverse events in clinical trials were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis).iii

About the UNCOVER Studies

The UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies are double-blind, multicentre, Phase III studies evaluating more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries.iii

All three studies evaluated the safety and efficacy of different dosing regimens of ixekizumab (80 mg every two or four weeks, following a 160-mg starting dose) compared to placebo after 12 weeks.iii

·       UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks.iv

·       UNCOVER-1, UNCOVER-2 and UNCOVER-3 also evaluated response rates with ixekizumab during the maintenance period through 60 weeks, with UNCOVER-1 and UNCOVER-2 employing a randomized withdrawal design.iii,iv

·       In these studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0 or 1.iiiPASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin, while the sPGA is the physician’s assessment of severity of a patient’s psoriasis lesions overall at a specific point in time.vi Both assessment tools (PASI and sPGA) are in line with CHMP guidelines to assess the effectiveness of treatments for psoriasis.vii

 

News Articles [89 Associated News Articles listed on BioPortfolio]

Plaque Psoriasis Pipeline Insight, 2018 [Report Updated: 14022018] Prices from USD $1250

"Plaque Psoriasis Pipeline Insight, 2018 report by DelveInsight offers comprehensive Insight of the pipeline under development therapeutics scenario and growth prospects across Plaque Psoriasis devel...

Human medicines European public assessment report (EPAR): Taltz, ixekizumab, Revision: 4, Authorised

Medical Affairs Reputations: Psoriasis EU5 2018 [Report Updated: 01022018] Prices from USD $6365

Compare 12 psoriasis medical affairs teams. See how your team stacks up to the market leader.In the EU5, several of the psoriasis medical affairs teams we surveyed are running neck and neck with at le...

Fujifilm Kyowa Kirin Biologics Partners with Mylan to Commercialize Biosimilar to Humira® (adalimumab)

Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced the company will partner with Mylan N.V. (NASDAQ:MYL) to commercialize FKB327, a biosimilar to Humira® (adalimumab) devel...

Plaque Psoriasis Market Insight, Epidemiology and Market Forecast 2027 [Report Updated: 14022018] Prices from USD $6250

DelveInsight's "Plaque Psoriasis Market Insight, Epidemiology and Market Forecast 2027" report provides a detailed analysis of the Plaque Psoriasis epidemiology and market outlook for the 7MM.Mark...

Medical Affairs Reputations: Psoriasis US 2018 [Report Updated: 01022018] Prices from USD $6365

Close rivalries among US psoriasis medical affairs teams. Will your team come out on top?In the US, nearly all of the psoriasis medical affairs teams we surveyed are running neck and neck with at leas...

CalciMedica Inc Pharmaceuticals Healthcare Deals and Alliances Profile [Report Updated: 27022018] Prices from USD $250

SummaryCalciMedica Inc CalciMedica is a pharmaceutical company that develops small molecule drugs for the treatment of inflammatory and autoimmune disorders and organ transplant rejection. The company...

Moderate Psoriasis Epidemiology Forecast to 2027 [Report Updated: 14022018] Prices from USD $3250

DelveInsight's "Moderate Psoriasis Epidemiology Forecast, 2027 report provides a comprehensive analysis of the Moderate Psoriasis epidemiology, providing the historical and forecasted data for th...

Moderate Psoriasis Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2018 [Report Updated: 14022018] Prices from USD $2250

IntroductionDelveInsight's, Moderate Psoriasis Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2018" report provides comprehensive insights about marketed and Phase III products fo...

Sienna Biopharmaceuticals Inc SNNA Pharmaceuticals Healthcare Deals and Alliances Profile [Report Updated: 14032018] Prices from USD $250

SummarySienna Biopharmaceuticals Inc Sienna Biopharmaceuticals is a biopharmaceutical company that develops innovation therapies for inflammatory skin conditions and aesthetic conditions. It offers to...

Events [0 Results]

None

Companies [22 Associated Companies listed on BioPortfolio]

Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion d...

Arrien Pharmaceuticals

Arrien Pharmaceuticals is a targeted therapeutics drug discovery and development company. Arrien applies its proprietary fragment-based FIELDS drug discovery technology to targ...

Tiziana Life Sciences plc

Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules that treat human disease in oncology and immunology. The C...

Santalis Pharmaceuticals, Inc.

Santalis Pharmaceuticals, Inc. is a wholly-owned subsidiary of TFS Corporation, Ltd. (ASX: TFC). Santalis, and its sister company, ViroXis, were acquired by TFS in July 2015 and a...

Ziarco Pharma Ltd.

Ziarco is a clinical-stage biotechnology company developing innovative therapeutics targeting dermatological and inflammatory diseases. ZPL-389, the Company’s lead compound, ...

Akaal Pharma Pty Ltd.

Akaal Pharma Pty Ltd (Akaal Pharma) is a clinical-stage drug discovery and development company focused on the development of novel small molecule drugs for the treatment of inflam...

Provectus Biopharmaceuticals, Inc.

Provectus Biopharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells...

Shape Pharmaceuticals, Inc.

Shape Pharmaceuticals, Inc. is developing SHP-141, a novel, topical, “soft-drug” HDAC inhibitor for the treatment of patients with cutaneous T cell lymphoma (CTCL) and p...

Helmedix Pty Ltd

Helmedix is developing new therapies for autoimmune diseases. The company has identified peptides derived from helminthic worms that have immune-modulating properties. These peptides are being explo...

HealOr

Founded in 2002, HealOr is a privately owned, clinical-stage specialty biopharmaceutical company developing a first-in-class pipeline of topical therapeutics to treat a variety of...

Clinical Trials [636 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of 2 Secukinumab Regimens in 90 kg or Higher Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Demonstrate superiority of secukinumab high dose over standard dose in heavy body weight subjects with moderate to severe plaque psoriasis.

Ovarian Reserve in Patients With Psoriasis

Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Autoimmune diseases including psoriasis are linked to premature ovarian reserve. This s...

A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Rheumatoid Arthritis (RA) or Psoriasis

To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with RA or psoriasis (Part 2) To assess the pharmacokinetic (PK) pr...

Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

15 patients with PRP will be treated with ixekizumab for 24 weeks to determine safety and efficacy. Participants are required to travel to Portland, OR only for the first visit and week-24...

Resolvin D1 in Psoriasis Before and After Narrowband UVB Phototherapy

• Assessment of tissue level of resolvin D1 in psoriasis in comparison to its level in healthy controls in order to verify its role in the pathogenesis of psoriasis.

A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to evaluate the efficacy and safety of mirikizumab in participants with moderate to severe plaque psoriasis.

Risankizumab Versus Secukinumab for Subjects With Moderate to Severe Plaque Psoriasis

The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psorias...

Effect of Brodalumab Compared to Placebo on Vascular Inflammation in Moderate-to-severe Psoriasis

A randomised, double-blind, placebo-controlled, trial to evaluate the efficacy of brodalumab monotherapy on vascular and systemic inflammation by 18F-FDG-PET/CT in subjects with moderate-t...

Characterization of Cutaneous Microbiota in the Psoriasis Pathogenesis

The skin harbors a complex and dynamic microbiota constituted by numerous microorganisms that live in symbiosis with the host. The specific etiology of psoriasis is still not-well understo...

Serum Granulysin Level as a Marker to Detect the Severity of Psoriasis

Psoriasis is a chronic inflammatory and proliferative papulosquamous skin disease of unknown cause,overexpression of Anti Microbial Peptides is characteristic of psoriasis. Granulysin is ...

PubMed Articles [293 Associated PubMed Articles listed on BioPortfolio]

Proanthocyanidins: novel treatment for psoriasis that reduces oxidative stress and modulates Th17 and Treg cells.

Psoriasis is a common, chronic, inflammatory skin disease that affects 2%-4% of the global population. Recent studies have shown that increased oxidative stress (OS) and T-cell abnormalities are centr...

Randomized, controlled study of bleselumab (ASKP1240) pharmacokinetics and safety in patients with moderate-to-severe plaque psoriasis.

This study evaluated pharmacokinetics (PK), efficacy, safety, and tolerability of bleselumab - a fully-human anti-CD40 monoclonal recombinant IgG4. Patients with moderate-to-severe psoriasis were rand...

Indirect co-cultures of healthy mesenchymal stem cells restore the physiological phenotypic profile of psoriatic mesenchymal stem cells.

Psoriasis microenvironment, characterized by an imbalance between Th1/Th17 and Th2 cytokines, influences also mesenchymal stem cells (MSCs) phenotypic profile. MSCs from healthy donors (H-MSCs) can ex...

The Therapeutic Potential and Molecular Mechanism of Isoflavone Extract against Psoriasis.

Psoriasis is a common inflammatory disease. It affects 1-3% of the population worldwide and is associated with increasing medical costs every year. Typical psoriatic skin lesions are reddish, thick, s...

An App Supporting Psoriasis Patients Improves Adherence to Topical Treatment: A randomised controlled trial.

Adherence to topical psoriasis treatments is low which leads to unsatisfactory treatment results. Smartphone applications (apps) for patient support exist, but their potential to improve adherence has...

Successful treatment with interleukin-17A antagonists of generalized pustular psoriasis in patients without IL36RN mutations.

Generalized pustular psoriasis (GPP) is a potentially life-threatening disease that can be attributed to mutations in IL36RN in a subgroup of patients. In small trials, interleukin (IL)-17A and IL-17R...

Alteration of serum thymus and activation-regulated chemokine level during biologic therapy for psoriasis: Possibility as a marker reflecting favorable response to anti-interleukin-17A agents.

Biologics show great efficacy in treating psoriasis, a chronic inflammatory skin disease. The high cost and side-effects of biologics, dose-reduction, elongation of administration interval and suspens...

Pediatric case of generalized pustular psoriasis developing acute pancreatitis.

Glabridin, an isoflavan from licorice root, ameliorates imiquimod-induced psoriasis-like inflammation of BALB/c mice.

In this paper, we investigate the effect of glabridin (Glab) on psoriasis. We observed that Glab significantly suppressed the levels of nitric oxide (NO), NF-κB subunit p65, interleukin (IL)-6, and I...

Sympathetic Nerve Hyperactivity in the Spleen: Causal for Nonpathogenic-Driven Chronic Immune-Mediated Inflammatory Diseases (IMIDs)?

Immune-Mediated Inflammatory Diseases (IMIDs) is a descriptive term coined for an eclectic group of diseases or conditions that share common inflammatory pathways, and for which there is no definitive...

Videos

None available.

Medical and Biotech [MESH] Definitions

A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.

A topical anti-inflammatory glucocorticoid used in DERMATOSES, skin allergies, PSORIASIS, etc.

A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.

An anthracene derivative that disrupts MITOCHONDRIA function and structure and is used for the treatment of DERMATOSES, especially PSORIASIS. It may cause FOLLICULITIS.

A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Antibodies
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

Cytokine
Cytokines include chemokines, lymphokines, and monokines. Cells of the immune system communicate with one another by releasing and responding to chemical messengers called cytokines. These proteins are secreted by immune cells and act on other cells to...

Cytokine Tumour Necrosis Factor (TNF)
TNF is a compound that is classified as a cytokine which plays a central role in the cellular mechanisms of apoptosis or cell death. However, there are a number of different kinds of TNF, just under twenty, but the family of molecules have very similar a...

review and buy Ixekizumab (Taltz) market research data and corporate reports here

Channels Quicklinks