Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04537689
Status:
RECRUITING
Last Update Posted:
2022-11-25
First Post:
2020-08-28
Brief Title:
Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
Official Title:
Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis Compared to Standard Care --- a Pragmatic Observational Study
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Psoriasis PsO is a systemic immune disease that affect 2-4 of the population worldwide PsO causes tremendous burden in terms of quality of life psychological impact disability and work productivity of affected individuals PsO is associated with an increased risk of cardiovascular morbidities and mortality in the long term Up to 30 of PsO patients develop psoriatic arthritis PsA over time causing joint deformities and further disabilities Majority of patients with PsA developed PsO first and arthritis develop 5-10 years afterwards PsA and PsO are increasingly recognized as two entities under the umbrella of psoriatic diseases
Advances in biological treatments have greatly improved the prognosis of patients with PsO Remarkable efficacies have been demonstrated for patients with moderate to severe PsO in randomized controlled trials RCTs However the high cost of biological treatment is one of the major barriers to prescription of biological treatment and many patients may have limited access to these treatments
The best strategy of treatment for PsO that takes into account efficacy and cost effectiveness is unknown For instance whether some PsO patients can stop biological treatment and be retreated with non-biologic medications upon relapse which may enhance cost effectiveness of treatment Preliminary studies have shown that some PsO patients were able to maintain good control of disease without medications after biologics withdrawal The patho-immunological mechanisms behind long term remission after drug withdrawal is poorly understood Better understanding on patho-immunological mechanisms on maintenance of remission and relapses will advance the development of biomarkers that eventually guide development of best treatment strategies for PsO
Ixekizumab is a humanized immunoglobulin G4 IgG4 kappa monoclonal antibody targeting interleukin IL-17A It is highly efficacious in the treatment of plague PsO with and favorable safety profile as shown in randomized controlled trials and is an approved treatment for moderate-to-severe PsO by the US Food and Drug Administration and Health Sciences Authority With the proven efficacies ixekizumab could be a choice of first-line treatment for patients with moderate to severe PsO The 2013 American Academy of Dermatology position statement have stated that the old paradigm of stepwise-therapy starting first with phototherapy and oral systemic therapies before biologic treatment is not required for patients with moderate to severe PsO In the recent 2017 update of the European S3 guidelines also recommend the use of IL-17 inhibitors as either a first- or second-line agent In a RCT that evaluated relapses after withdrawal of ixekizumab among patients who achieved a clearance of PsO loss of PsO clearance were seen after a median of 20 weeks Response can be successfully recaptured in over 80 of patients with retreatment with ixekizumab suggesting that the treatment regimen could be interrupted in some patients However real-life data on biologic treatment or withdrawal for moderate to severe PsO is scatty
Advances in biological treatments have greatly improved the prognosis of patients with PsO Remarkable efficacies have been demonstrated for patients with moderate to severe PsO in randomized controlled trials RCTs However the high cost of biological treatment is one of the major barriers to prescription of biological treatment and many patients may have limited access to these treatments
The best strategy of treatment for PsO that takes into account efficacy and cost effectiveness is unknown For instance whether some PsO patients can stop biological treatment and be retreated with non-biologic medications upon relapse which may enhance cost effectiveness of treatment Preliminary studies have shown that some PsO patients were able to maintain good control of disease without medications after biologics withdrawal The patho-immunological mechanisms behind long term remission after drug withdrawal is poorly understood Better understanding on patho-immunological mechanisms on maintenance of remission and relapses will advance the development of biomarkers that eventually guide development of best treatment strategies for PsO
Ixekizumab is a humanized immunoglobulin G4 IgG4 kappa monoclonal antibody targeting interleukin IL-17A It is highly efficacious in the treatment of plague PsO with and favorable safety profile as shown in randomized controlled trials and is an approved treatment for moderate-to-severe PsO by the US Food and Drug Administration and Health Sciences Authority With the proven efficacies ixekizumab could be a choice of first-line treatment for patients with moderate to severe PsO The 2013 American Academy of Dermatology position statement have stated that the old paradigm of stepwise-therapy starting first with phototherapy and oral systemic therapies before biologic treatment is not required for patients with moderate to severe PsO In the recent 2017 update of the European S3 guidelines also recommend the use of IL-17 inhibitors as either a first- or second-line agent In a RCT that evaluated relapses after withdrawal of ixekizumab among patients who achieved a clearance of PsO loss of PsO clearance were seen after a median of 20 weeks Response can be successfully recaptured in over 80 of patients with retreatment with ixekizumab suggesting that the treatment regimen could be interrupted in some patients However real-life data on biologic treatment or withdrawal for moderate to severe PsO is scatty
Detailed Description:
First the investigators hypothesize that a proportion of patients with moderate to severe PsO may sustain reasonable good outcomes when a short course of ixekizumab is withdrawn
Second the investigators hypothesize that the investigators can identify the perturbations in the architecture of the immunome which are pathogenic and to discriminate such perturbations based on treatment and clinical responses thus distilling theragnostic signatures
Therefore the objectives of the study are as follow
Specific aim 1 To describe the clinical course sustained good outcomes relapse rate time to relapse and quality of life in PsO patients who stopped a 6-month short course treatment of ixekizumab till the end of 2-years
Specific aim 2 To identify the genomic and immunomic signatures in skin biopsies and blood in PsO patients who has good outcomes PASI 75 at 6 months comparing treatment vs pragmatic control
Specific aim 3 To identify the genomic and immunomic signatures in skin biopsies and blood in PsO patients who sustained good outcomes at 1 year after stopping ixekizumab compared to those relapsed
Second the investigators hypothesize that the investigators can identify the perturbations in the architecture of the immunome which are pathogenic and to discriminate such perturbations based on treatment and clinical responses thus distilling theragnostic signatures
Therefore the objectives of the study are as follow
Specific aim 1 To describe the clinical course sustained good outcomes relapse rate time to relapse and quality of life in PsO patients who stopped a 6-month short course treatment of ixekizumab till the end of 2-years
Specific aim 2 To identify the genomic and immunomic signatures in skin biopsies and blood in PsO patients who has good outcomes PASI 75 at 6 months comparing treatment vs pragmatic control
Specific aim 3 To identify the genomic and immunomic signatures in skin biopsies and blood in PsO patients who sustained good outcomes at 1 year after stopping ixekizumab compared to those relapsed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None