Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Necrosis

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

Other Dietary Supplements

All Drugs and Chemicals

Acidophilus

In the treatment group, intervention was given in the form of standard therapy and probiotic Lactobacillus plantarum IS 10605 in the amount of 2x1010 CFU for 12 weeks.

In the placebo group, intervention was given in the form of standard therapy and placebo 2x1 sachets for 12 weeks.

Healthy control group was not given any treatment. Stool samples were taken to examine the gut microbiota profile.

Indonesian original probiotic, given in capsule form with a dose of 2 x 1010 CFU

Lactobacillus Plantarum IS-10506

Placebo is an empty drug, given in capsule form with a dose of 2x1 sachets

Placebo

Menul Ayu Umborowati, Specialist

Menul Ayu Umborowati

Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs.

The provision of probiotic Lactobacillus plantarum IS-10506, an Indonesian original probiotic strain, is expected to be an effective, safe, and affordable alternative for psoriasis treatment for psoriasis patients in Indonesia.

This study aimed to evaluate changes in gut microbiota profile, cytokines IL-17, TNF-a, IL-10, Foxp3, and disease severity of psoriasis vulgaris patients after supplementation with Lactobacillus plantarum IS-10506. The results of this study are expected to be the basis for the use of Lactobacillus plantarum IS-10506 in the therapy of psoriasis vulgaris which is included in the Clinical Practice Guide in Indonesia, which will ultimately help improve the quality of life of psoriasis patients.

Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs. Psoriasis can increase the incidence of other diseases such as joint disorders, cardiovascular disorders, and psychological. Symptoms of psoriasis on the skin are red, well-defined plaques covered with thick, white, layered scales. The incidence of psoriasis is quite large, known to affect 0.09 - 11.4% of the world's population with rates varying between regions. Data in Indonesia is estimated that there are 2-6 million psoriasis sufferers in 2010, with a prevalence range of 1-3% in several teaching hospitals. During the period from 2016 to 2018, psoriasis vulgaris patients in the outpatient unit of RSUD Dr. Soetomo Surabaya recorded as many as 208 or 0.46% of all skin patients.

One of the mechanisms of psoriasis is abnormalities in Treg cells (cells that play a role in expressing Foxp3), resulting in an imbalance in the immune system with the dominance of T helper 1 (Th1) and T helper 17 (Th17) cells. In addition, the composition of the gut microbiota (collection of bacteria) in psoriasis patients is different from that of healthy people. The composition of the gut microbiota can be influenced by race, geography, and eating habits. Until now there has been no report on the intestinal microbiota profile of psoriasis patients in Indonesia.

The provision of probiotic Lactobacillus plantarum IS-10506, is expected to be an effective, safe, and affordable alternative for psoriasis treatment for psoriasis patients in Indonesia. Lactobacillus plantarum IS-10506 is produced from Dadih, a traditional fermented milk from West Sumatra, Indonesia. This probiotic is expected to be most compatible with the composition of the gut microbiota of Indonesians because it comes from an environment with similar exposure to pathogenic bacteria.

This study aimed to evaluate changes in gut microbiota profile, cytokines IL-17, TNF-a, IL-10, Foxp3, and disease severity of psoriasis vulgaris patients after supplementation with Lactobacillus plantarum IS-10506. The results of this study are expected to be the basis for the use of Lactobacillus plantarum IS-10506 in the therapy of psoriasis vulgaris which is included in the Clinical Practice Guide in Indonesia, which will ultimately help improve the quality of life of psoriasis patients.

A double blinded randomized clinical trial using a prospective cohort method in psoriasis vulgaris patients with purposive sampling.

Probiotic and placebo packaging are made the same, and drug code is randomized by pharmacy

Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris

Analysis of Gut Microbiota, Psoriasis Area and Severity Index, Interleukin-17, Tumor Necrosis Factor -α, Interleukin-10, and Foxp3 in Psoriasis Vulgaris After Supplementation With Lactobacillus Plantarum IS-10506

Alpha and beta diversity in gut microbiota profiles

Changes in serum levels of TNF-α, IL-17, IL-10, and Foxp3 by ELISA method

Changes in PASI scores after the intervention

Changes in the score of impaired quality of life due to skin diseases experienced using the DLQI questionnaires

Universitas Airlangga

Dr. Soetomo General Hospital

doctor, dermatovenereologist

Anti-Inflammatory Agents

Antirheumatic Agents

Adalimumab

Tumor Necrosis Factor Inhibitors

Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.

Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28.

Participants will receive subcutaneous (SC) injection of adalimumab

Participants will receive SC injection of ABP 501

ABP 501

Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.

A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (Adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Participants analyzed according to actual treatment received.

Participants analyzed according to treatment received.

Time to reach maximum serum concentration.

The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).

A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

A PASI 100 response is a 100% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs.

A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

An EOI is defined as a noteworthy event for a particular product or class of products that a sponsor may wish to monitor carefully. It could be serious or non-serious and could include events that might be potential precursors or prodromes for more serious medical conditions in susceptible individuals.

Anti-drug antibody samples were drawn prior to investigational product administration at dosing visits.

Amgen

All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Participants with Ps received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 \[80 mg\], Week 2/Day 8 \[40 mg\], Week 4, Week 6, Week 8, and Week 10 \[40 mg\]) during the Lead-in Period.

Period 1 (Lead-in Period)

Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.

Period 2 (Continued-use Group)

Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).

Period 2 (Switching Group)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Data is reported for the Safety Analysis Set and reflects data collected at baseline for the switching and continued use groups.

Study Director

The Pharmacokinetic (PK) Parameter Analysis Set consists of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between Weeks 28 and 30.

Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

The PK Parameter Analysis Set consists of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between weeks 28 and 30.

Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

The analyses of the secondary PK endpoints is based on the PK Concentration Analysis Set, which included all randomized participants who received at least 1 dose of investigational product (IP) post-randomization and had at least 1 reported serum concentration of ABP 501 or adalimumab on or after the day of randomization.

Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Week 12

Week 16

Week 20

Week 28

The analyses of the secondary PK endpoints is based on the PK Concentration Analysis Set, which included all randomized participants who received at least 1 dose of IP post-randomization and had at least 1 reported serum concentration of ABP 501 or adalimumab on or after the day of randomization. All participants reported in the overall number of participants analyzed contributed data to this analysis.

Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Based on the per-protocol (PP) efficacy analysis set as observed, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.

PASI Percent Improvement From Baseline (Day 1) to Week 30

Based on the PP efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.

Number of Participants Achieving PASI 75 Response at Week 30

Number of Participants Achieving PASI 90 Response at Week 30

Number of Participants Achieving PASI 100 Response at Week 30

TEAE

Serious TEAE

Population from the Safety Analysis Set (SAS). Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

Population from the SAS. Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.

Number of Participants Experiencing Events of Interest (EOI)

Participants with a post-randomization result

Binding antibody negative or no result prior to the first dose of post-randomization IP

Binding antibody positive with negative/no result prior to first dose post-randomization

Transient binding antibody positive with negative/no result prior to first dose post-randomization

Neutralizing antibody negative or no result prior to the first dose of post-randomization IP

Neutralizing antibody positive with negative/no result prior to first dose post-randomization

Transient neutralizing antibody positive with negative/no result prior first dose post-randomization

Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization

Participants with plaque psoriasis (Ps) received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 \[80 mg\], Week 2/Day 8 \[40 mg\], Week 4, Week 6, Week 8, and Week 10 \[40 mg\]) during the Lead-in Period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris	NCT05254249	Psoriasis Vulga...	Lactobacillus P... Placebo	18 Years - 70 Years	Dr. Soetomo General Hospital
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis	NCT05073315	Plaque Psoriasi...	Adalimumab ABP 501	18 Years - 75 Years	Amgen
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis	NCT05073315	Plaque Psoriasi...	Adalimumab ABP 501	18 Years - 75 Years	Amgen
Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris	NCT05254249	Psoriasis Vulga...	Lactobacillus P... Placebo	18 Years - 70 Years	Dr. Soetomo General Hospital

Spots Global Cancer Trial Database for psoriasis area and severity index