Delving into the Latest Updates on Risankizumab-RZAA with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Risankizumab, Risankizumab (Genetical Recombination), 利生奇珠单抗

+ [5]

Target

IL-23p19

Mechanism

IL-23p19 inhibitors(Interleukin-23 subunit p19 inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesDigestive System Disorders+ [2]

Active Indication

Colitis, UlcerativeCrohn DiseasePustulosis of Palms and Soles+ [8]

Inactive Indication

Ankylosing SpondylitisCrohn's disease, active moderateCrohn's disease, active severe+ [5]

Originator Organization

AbbVie, Inc.

Active Organization

Boehringer Ingelheim Pharma GmbH & Co., KG

AbbVie, Inc.AbbVie Deutschland GmbH & Co. KG

+ [1]

Inactive Organization

Boehringer Ingelheim GmbH

Drug Highest PhaseApproved

First Approval Date

JP (26 Mar 2019),

Arthritis, PsoriaticErythrodermic psoriasisPsoriasis vulgaris+ [1]

RegulationOrphan Drug (US)

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Gene Sequence

Sequence Code 181110L

Source: *****

Sequence Code 181112H

Source: *****

Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body's immune system not working properly.
This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label, which means that both participants and study doctors know which study treatment is given to participants
Participants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Start Date10 May 2024

Sponsor / Collaborator

AbbVie, Inc.

NCT06346288 / RecruitingPhase 4

A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of Risankizumab in Breast Milk of Lactating Women With Inflammatory Bowel Disease Who Are Receiving Risankizumab Therapeutically

Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBD
Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn's Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States.
Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months.
Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects.

Start Date06 May 2024

Sponsor / Collaborator

AbbVie, Inc.

NCT06298188 / Not yet recruitingNot ApplicableIIT

Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study

The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.
This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.

Start Date01 Mar 2024

Sponsor / Collaborator

Shaare Zedek Medical Center

100 Clinical Results associated with Risankizumab-RZAA

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100 Translational Medicine associated with Risankizumab-RZAA

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100 Patents (Medical) associated with Risankizumab-RZAA

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401

Literatures (Medical) associated with Risankizumab-RZAA

01 Mar 2024·The Annals of pharmacotherapy

Choosing Systemic Agents for Psoriasis

Author: Kontzias, Christina ; Feldman, Steven R ; Chandy, Rithi

Treatment options for moderate-to-severe psoriasis depend on drug efficacy and safety, patient preferences, comorbidities, and cost—no drug dominates across all dimensions. Interleukin (IL)-17 inhibitors may be preferred for fast-acting treatment, while the 3-month schedule of risankizumab, ustekinumab, or tildrakizumab may be attractive for patients who prioritize fewer injections. Phototherapy is suitable for patients who wish to avoid systemic agents or when cost is a concern. For patients with poor adherence, infliximab or tildrakizumab may be well suited as they require in-office administration. Dermatologists can educate patients on available therapies to find a regimen best suited to their needs.

01 Mar 2024·Journal of the European Academy of Dermatology and Venereology : JEADV

Risankizumab for the treatment of genital psoriasis: A 1‐year, real‐world experience

Letter

Author: Narcisi, A ; Gargiulo, L ; Sperduti, I ; Valenti, M ; Pacifico, A ; Ibba, L ; Frascione, P ; Costanzo, A ; Assorgi, C ; Orsini, D

01 Apr 2024·Rheumatology and therapy

Efficacy and Safety of Risankizumab in Patients with Psoriatic Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Review

Author: Cheng, Ting ; Zhou, Hao-Nan ; Xia, Guo-Mei ; Huo, Yue-Hong ; Liu, Yu-Xin ; Zhang, Rui-Yuan ; Su, Chang ; Zhang, Sheng-Xiao ; Tian, Hong-Yuan ; Su, Qin-Yi ; Li, Qian ; Zhang, He-Yi

INTRODUCTION:

Currently, the cause of psoriatic arthritis (PsA) is unknown, and the effectiveness of current drug treatments is unsatisfactory. In March 2019, the US Food and Drug Administration (FDA) approved risankizumab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, for the treatment of PsA in adults. This study aimed to conduct a meta-analysis of double-blind, randomized, placebo-controlled trials to evaluate the effectiveness and safety of risankizumab in moderate-to-severe PsA.

METHODS:

We conducted a thorough search of relevant databases from the establishment of the databases to October 1, 2023. We conducted a meta-analysis using Stata 12.0 and utilized I² and Egger tests to assess heterogeneity and publication bias among the studies. Bias assessment was performed using the risk bias map and bias risk summary diagram generated by Revman5.4 software. The review protocols were registered on PROSPERO (CRD42023451894) and adhered to the preferred reporting item of system evaluation (PRISMA) guideline.

RESULTS:

Six randomized controlled trials (RCTs) involving 5038 patients with PsA treated with either risankizumab or placebo were included in the analysis. At 24 weeks, the risankizumab group demonstrated a significantly higher American College of Rheumatology-20 (ACR20) response rate compared to the placebo group (RR 1.760, 95% CI 1.568-1.977, P < 0.001). Additionally, the risankizumab group showed a significantly higher Minimal Disease Activity (MDA) response rate compared to the placebo group (RR 1.827, 95% CI 1.048-3.184, P < 0.05). The risankizumab group also exhibited improvement in Short Form 36 Questionnaire (SF-36) score (SMD 0.51, 95% CI 0.33-0.69, P < 0.001), with significantly lower Health Assessment Questionnaire Disability Index (HAQ-DI) score (SMD - 0.27, 95% CI - 0.37 to - 0.17, P < 0.001) and higher Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score (SMD 0.27, 95% CI 0.20-0.35, P < 0.001) compared to the placebo group. Moreover, the risankizumab group had a significantly lower Psoriasis Area and Severity Index (PASI) score (SMD - 6.12, 95% CI - 10.02 to 2.23, P < 0.001). A study by Mease et al. indicated that patients receiving risankizumab generally demonstrated numerical improvements in the Leeds Enthesitis Index (LEI), although the small sample size limits the evidence. Further research is necessary to provide evidence-based guidelines. There were no significant differences in the incidence of serious adverse events (SAE) and serious treatment-emergent adverse events (STEAE) between the risankizumab and placebo groups (RR 0.76, 95% CI 0.45-1.28, P = 0.31; RR 0.99, 95% CI 0.49-1.99, P = 0.97, respectively), and the overall incidence of adverse events (AE) was not comparable (RR 1.10, 95% CI 0.63-1.94, P = 0.73).

CONCLUSION:

Risankizumab showed superior efficacy across multiple outcome measures compared to placebo, with no significant increase in adverse events. Our findings endorse risankizumab as an excellent treatment option for PsA, offering valuable insights for clinicians and patients when choosing appropriate therapeutic interventions.

TRIAL REGISTRATION:

Retrospectively registered (CRD42023451894, 16 August 2023).

195

News (Medical) associated with Risankizumab-RZAA

20 Jun 2024

·www.fiercepharma.com

AbbVie's rising star Skyrizi nabs key ulcerative colitis FDA approval

With its latest approval, Skyrizi is now approved to treat both of the forms of inflammatory bowel disease. AbbVie’s fast-growing Humira successor Skyrizi is already on a roll with skyrocketing sales. Now, the IL-23 inhibitor is poised to take on an even larger share of Humira’s fading market dominance with a key expansion into ulcerative colitis. On Tuesday, the FDA granted Skyrizi approval to treat adult patents with moderately to severely active ulcerative colitis (UC). The approval adds some 1 million U.S. patients to the drug’s reach and makes Skyrizi the first IL-23 inhibitor cleared to treat both UC and Crohn’s, the two forms of inflammatory bowel disease (IBD). Following a 12-week induction period, patients can dose themselves at home with an on-body injector device “designed with patients in mind," according to AbbVie's press release. The device adheres to the body and delivers the med in about five minutes. Even in a crowded disease area, Skyrizi boasts an edge with prescribers. A Spherix Global Insights poll of 101 gastroenterologists found that doctors are already on board with the med as a UC treatment, with one-third reporting that Skyrizi is a significant advance over existing products. Doctors favor AbbVie’s offering over Johnson & Johnson’s Tremfya and Abivax’s obefazimod, and most are highly familiar with the drug. One gastroenterologist said they prefer Skyrizi because it has “the best efficacy profile among the IL-23 agents.” After its Crohn's approval in 2022, Skyrizi has been a formidable IBD rival to Johnson & Johnson’s blockbuster Stelara. The AbbVie drug has been taking a “significant share” of the J&J med’s sales, AbbVie executives said on an April earnings call. Coupled with its other two approvals in psoriatic arthritis and plaque psoriasis, AbbVie is making strides in its plan to build up Skyrizi—as well as JAK inhibitor Rinvoq—to make up for falling Humira sales. Last year, Skyrizi’s sales reached $7.7 billion, a 50% leap over 2022. The company has long been working on the double threat to buoy its immunology profile as once-king Humira falls to biosimilar competition following its loss of exclusivity in 2023. With the still-rising success of the two drugs, it’s looking like the plan might be coming to fruition even better than AbbVie once hoped. Analysts at GlobalData expect Skyrizi sales to peak in 2030 at $19.7 billion, while Rinvoq should peak at $12.3 billion for a total haul of $32 billion. By the end of the decade, the duo is poised to contribute 42% of AbbVie’s total revenue. “Given their 2030 drug expiries, these drugs are estimated to not only bolster sales for an extended period of time but […] are [also] poised for long-term sales growth, enabling the company to not only financially recover from Humira’s expiry but to also continue its position as a formidable player within the immunology therapy area,” GlobalData pharma analyst Jasper Morley said in the report.

Drug ApprovalBiosimilar

20 Jun 2024

·www.fiercepharma.com

J&J's subcutaneous version of Tremfya excels in Crohn's disease study

Tremfya's expansion comes as Johnson & Johnson prepares to lose exclusivity on its immunology stalwart Stelara. In May, Johnson & Johnson touted the success of its intravenous (IV) formulation of Tremfya in two head-to-head trials against its own Stelara in Crohn’s disease. A month later, a subcutaneous (SC) version of Tremfya has excelled as an induction therapy in a phase 3 Crohn’s disease study. In the GRAVITI trial, Tremfya met both co-primary endpoints, delivering a statically significant improvement versus placebo at week 12 for both remission and endoscopic response. With the results of the three studies, Tremfya has shown its potential to become to the first IL-23 inhibitor to offer two induction options for Crohn’s disease, J&J said in a press release. “Having both SC and IV induction options provides choice and versatility for patients and providers,” David Lee, M.D., Ph.D., J&J’s global therapeutic head immunology, said in a release. “Tremfya is poised to be the only IL-23 inhibitor to offer a full SC therapy for both induction and maintenance in Crohn’s disease.” J&J plans to present the full trial data at upcoming medical meetings and will share the results with regulators, the company said. The GRAVITI study evaluated Tremfya SC induction therapy in patients with moderate to severe Crohn’s who experienced an inadequate response or failed to tolerate conventional treatments (corticosteroids or immunomodulators) or biologic drugs (TNF agonists or Takeda’s Entyvio). In addition to achieving its primary endpoints, GRAVITI reached statistical significance compared to placebo in all secondary objectives, J&J said. The secondary trial measures looked at remission and response rates at various time points, plus the rates of adverse events leading to treatment discontinuation, according to clinicaltrials.gov. In 2022, AbbVie’s Skyrizi was the first IL-23 inhibitor approved to treat Crohn’s. Then last year, it topped J&J’s Stelara in its own head-to-head study, facilitating remission in 61% of patients at week 48 versus 41% for Stelara. Tremfya is one of J&J’s most important medicines. It was approved for plaque psoriasis in 2017 and added a psoriatic arthritis nod in 2020. In March of this year, J&J submitted for approval for Tremfya to treat ulcerative colitis. It generated sales of $3.1 billion in 2023, which was an increase of 18% from the previous year. Tremfya’s emergence is timely as J&J is girding for the loss of exclusivity of Stelara, which accounted for $10.9 billion in sales in 2023, which was 13% of the company’s total revenue. Stelara biosimilars are on their way this year in Europe and U.S. copycats are expected to be available early next year.

Clinical ResultDrug ApprovalPhase 3Immunotherapy

19 Jun 2024

·firstwordpharma.com

AbbVie bags expanded FDA nod for Skyrizi in ulcerative colitis

AbbVie announced Tuesday that the FDA approved Skyrizi (risankizumab-rzaa) for the treatment of moderate-to-severe active ulcerative colitis (UC) in adults, making it the first IL-23-specific inhibitor cleared for both UC and Crohn’s disease (CD) in the US. “Today's approval…expands our IBD [inflammatory bowel disease] portfolio…helping address ongoing needs of patients” with UC, remarked Roopal Thakkar, chief medical officer of global therapeutics at AbbVie. The approval was backed by results from two late-stage studies – the 12-week induction study INSPIRE and the 52-week maintenance study COMMAND, both of which met the main goal of clinical remission, alongside the secondary endpoint of endoscopic improvement.AbbVie noted that Skyrizi’s dosing for this indication involves a 12-week induction period with three 1200mg doses every four weeks, followed by a maintenance regimen of either 180mg or 360mg every eight weeks that can be administered at home using an on-body injector.The approval marks the fourth indication for Skyrizi in the US across immune-mediated inflammatory diseases. Its first approval came through in 2019 for moderate-to-severe plaque psoriasis, with a subsequent label expansion in 2022 for active psoriatic arthritis. In June 2022, the FDA cleared the IL-23 inhibitor for the treatment of moderate-to-severe active CD, based on positive findings from the late-stage ADVANCE and MOTIVATE induction trials. Skyrizi, which is partnered with Boehringer Ingelheim, is also awaiting approval in the EU as a potential treatment for UC, after securing a positive opinion by the European drug advisory panel last month. The biologic made nearly $2.4 billion in global sales last year.AbbVie’s portfolio of targeted therapies for UC also includes Rinvoq (upadacitinib), which was cleared by the FDA in 2022. The drugmaker is looking to strengthen its foothold in IBD through a recent licensing deal potentially worth $1.7 billion with China's FutureGen Biopharmaceutical to develop a next-generation anti-TL1A antibody. Other recent entrants in the UC arena include Pfizer’s Velsipity (etrasimod) and Lilly’s Omvoh (mirikizumab-mrkz), both approved in the US in October last year.

Drug ApprovalLicense out/inClinical StudyClinical Result

100 Deals associated with Risankizumab-RZAA

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KEGG	Wiki	ATC	Drug Bank
-	Risankizumab-RZAA	L04AC18	DB14762

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Colitis, Ulcerative	US	AbbVie, Inc.	18 Jun 2024
Crohn Disease	US	AbbVie, Inc.	16 Jun 2022
Pustulosis of Palms and Soles	KR	AbbVie Ltd. (South Korea)	03 Dec 2019
Plaque psoriasis	US	AbbVie, Inc.	23 Apr 2019
Arthritis, Psoriatic	JP	AbbVie, Inc.	26 Mar 2019
Erythrodermic psoriasis	JP	AbbVie, Inc.	26 Mar 2019
Psoriasis vulgaris	JP	AbbVie, Inc.	26 Mar 2019
Pustular psoriasis	JP	AbbVie, Inc.	26 Mar 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ulcerative colitis, active moderate	NDA/BLA	EU	AbbVie Deutschland GmbH & Co. KG	28 Aug 2023
Ulcerative colitis, active severe	NDA/BLA	EU	AbbVie Deutschland GmbH & Co. KG	28 Aug 2023
Juvenile Arthritis	Phase 3	US	AbbVie, Inc.	16 Jan 2024
Juvenile Arthritis	Phase 3	DE	AbbVie, Inc.	16 Jan 2024
Juvenile Arthritis	Phase 3	IT	AbbVie, Inc.	16 Jan 2024
Juvenile Arthritis	Phase 3	PL	AbbVie, Inc.	16 Jan 2024
Juvenile Arthritis	Phase 3	ES	AbbVie, Inc.	16 Jan 2024
Crohn's disease, active moderate	Phase 3	US	AbbVie, Inc.	18 Dec 2017
Crohn's disease, active moderate	Phase 3	US	Boehringer Ingelheim Pharma GmbH & Co., KG	18 Dec 2017
Crohn's disease, active moderate	Phase 3	AR	Boehringer Ingelheim Pharma GmbH & Co., KG	18 Dec 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04713592 (IMMprint, CTgov)	Phase 3	Keratoderma, Palmoplantar \| Plaque psoriasis	174	Placebo for Risankizumab+Risankizumab (Placebo)	vjrpwmzucn(cyrehbtfxb) = upqhrdolba lcmtpedhta (lsqsrtgput, twczjxlfil - qihraipmhv) View more	-	14 Jun 2024
				Risankizumab (Risankizumab)	vjrpwmzucn(cyrehbtfxb) = skpycsookn lcmtpedhta (lsqsrtgput, nuomaeajfp - tliphjdfwo) View more
NCT04908475 (CTgov)	Phase 4	Plaque psoriasis	352	Apremilast (Period A: APR)	aaqgojgkss(cmnlznqjfe) = vdtytujsqg tetqobhdkg (cphuszsnok, hpdckfpfqz - reyswzpvpp) View more	-	30 Apr 2024
				Risankizumab (Period A: RZB)	aaqgojgkss(cmnlznqjfe) = rzmcmqyoum tetqobhdkg (cphuszsnok, fhwnqzsmho - rxghbojgdd) View more
NCT03675308 (KEEPsAKE 1, Pubmed)	Phase 3	Arthritis, Psoriatic	964	Risankizumab 150 mg	drtlazgvoh(grmncgfaru) = xhlyavzvso icfiqeufhr (tpdqpfwyfi ) View more	-	18 Mar 2024
				Placebo	drtlazgvoh(grmncgfaru) = eqkawjnkgc icfiqeufhr (tpdqpfwyfi ) View more
NCT03671148 (KEEPsAKE 2, Pubmed)	Phase 3	Arthritis, Psoriatic	443	Risankizumab 150 mg	lxeffrdgji(gxmuvotbwx) = dohefqzmto ceonotanuf (rmyppnajnb ) View more	-	18 Mar 2024
				Placebo	lxeffrdgji(gxmuvotbwx) = tlpzjvnads ceonotanuf (rmyppnajnb ) View more
KEEPsAKE 2 (ACR2023)	Phase 3	Arthritis, Psoriatic	-	Risankizumab 150 mg	djjpmypajr(jhobhsosda) = trcvjhxwnz roqpvlsgao (rwxdziqdhp ) View more	Positive	13 Nov 2023
				Placebo+Risankizumab 150 mg	djjpmypajr(jhobhsosda) = ceuqodmuzi roqpvlsgao (rwxdziqdhp ) View more
NCT03047395 (LIMMitless, EADV 12023 \| EADV 22023)	Phase 3	Psoriasis	897	Risankizumab 150 mg Q12W	desbfwkyad(tngziwavtb) = yvrldctmmh nynswdxvsp (jwvodetyhk ) View more	Positive	11 Oct 2023
EADV2023	Not Applicable	IL-23	12	Risankizumab	dtrvejrasn(fbnwimzykx) = iculzsaymw lzzhoyxptr (wsbcmoovhx ) View more	Positive	11 Oct 2023
				Tildrakizumab	dtrvejrasn(fbnwimzykx) = dqakwslnhb lzzhoyxptr (wsbcmoovhx ) View more
NCT03047395 (LIMMitless, EADV2023)	Phase 2/3	Plaque psoriasis	955	Risankizumab 150 mg	xmklwiyauq(zzcwjepzoc) = fozwhngjaa fvrvfofjyf (ianpxgrfpq ) View more	Positive	11 Oct 2023
IMMpulse trial (EADV2023)	Phase 4	Plaque psoriasis	-	Risankizumab (RZB) 150 mg	umqexhpjpn(havqesrvsn) = owsaabcfpd gzcclavcib (dfcuauustb ) View more	-	11 Oct 2023
				Apremilast (APR) 30 mg BID	umqexhpjpn(havqesrvsn) = xegluwczdn gzcclavcib (dfcuauustb ) View more
KEEPsAKE 1 (EADV2023)	Phase 3	Arthritis, Psoriatic	-	Risankizumab 150 mg	kzfogqykax(ixikhoaldv) = syqrzdsqrj wfemfhqbeg (eqgyadgmlu ) View more	Positive	11 Oct 2023
				Placebo/Risankizumab 150 mg	kzfogqykax(ixikhoaldv) = gbvjhkwdif wfemfhqbeg (eqgyadgmlu ) View more