thalidomide and Palmoplantaris Pustulosis

thalidomide has been researched along with Palmoplantaris Pustulosis in 302 studies

Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.
2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group.

Research

Studies (302)

Authors

Clinical Trials (24)

Trial Overview

Trial Outcomes

Apparent Total Plasma Clearance When Dosed Orally (CL/F) for Apremilast

Apparent total plasma clearance (CL/F) of apremilast was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule. (NCT02576678)
Timeframe: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.

Apparent Total Volume of Distribution When Dosed Orally, Based on Study-State (Vss/F) or in the Terminal Phase (Vz/F)

Apparent total volume of distribution when dosed orally, based on study-state (Vss/F) or in the terminal phase (Vz/F). Pharmacokinetic parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule. (NCT02576678)
Timeframe: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.

Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose of Apremilast (AUC0-12)

Area under the plasma concentration-time curve from time zero to the 12 hours post dose was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule. (NCT02576678)
Timeframe: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration of Apremilast (AUC0-t)

Area under the plasma concentration-time curve from time zero to the last quantifiable time point and was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule. (NCT02576678)
Timeframe: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.

Maximum Observed Plasma Concentration (Cmax) of Apremilast

Maximum observed plasma concentration (Cmax) of apremilast. PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule. (NCT02576678)
Timeframe: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.

Terminal Phase Elimination Half-Life

Terminal-phase elimination half-life (t ½). PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule. (NCT02576678)
Timeframe: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.

Time to Maximum Plasma Concentration (Tmax) of Apremilast

Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data. PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule. (NCT02576678)
Timeframe: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

A TEAE is an adverse event with a start date on or after the date of the first dose of apremilast and no later than 28 days after the last dose of apremilast. An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. A serious AE is any untoward AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization or in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or constitutes an important medical event. The investigator assessment of severity/intensity of an event was defined as mild, moderate or severe. (NCT02576678)
Timeframe: From first dose of apremilast until 28 days after the last dose; up to 29 July 2019; median treatment duration for adolescents apremilast 20 mg and 30 mg was 50.00 and 50.57 weeks respectively and for children was 50.00 weeks.

Percentage of Participants With a PASI 75 Response at Week 12

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 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. (NCT02749370)
Timeframe: Baseline and week 12

"PSI Burning of Skin Lesions Component Score at Each Visit"

Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). (NCT02749370)
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24

"PSI Cracking of Skin Lesions Component Score at Each Visit"

Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). (NCT02749370)
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24

"PSI Flaking of Skin Lesions Component Score at Each Visit"

Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). (NCT02749370)
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24

"PSI Itch From Psoriasis Component Score at Each Visit"

Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). (NCT02749370)
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24

"PSI Pain From Skin Lesions Component Score at Each Visit"

Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). (NCT02749370)
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24

"PSI Redness of Skin Lesions Component Score at Each Visit"

Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). (NCT02749370)
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24

"PSI Scaling of Skin Lesions Component Score at Each Visit"

Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). (NCT02749370)
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24

"PSI Stinging of Skin Lesions Component Score at Each Visit"

Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). (NCT02749370)
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24

Number of Participants With Adverse Events

(NCT02749370)
Timeframe: From first dose of etanercept to 30 days after last dose, up to 28 weeks.

Patient Assessment of Treatment Satisfaction at Week 12

"Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from very dissatisfied to very satisfied." (NCT02749370)
Timeframe: Week 12

Patient Assessment of Treatment Satisfaction at Week 24

"Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from very dissatisfied to very satisfied." (NCT02749370)
Timeframe: Week 24

Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24

The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement. (NCT02749370)
Timeframe: Baseline and weeks 12 and 24

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)

"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 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement." (NCT02749370)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit

A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement. (NCT02749370)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With a PASI 50 Response at Each Visit

A PASI 50 response is a 50% 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 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. (NCT02749370)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With a PASI 75 Response at Each Visit

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 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. (NCT02749370)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With a PASI 90 Response at Each Visit

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 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. (NCT02749370)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1). (NCT02749370)
Timeframe: Weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported. (NCT02749370)
Timeframe: Weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported. (NCT02749370)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported. (NCT02749370)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

Psoriasis Symptom Inventory (PSI) Total Score at Each Visit

Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). The total score is the sum of the 8 responses, and ranges from 0 to 32. Higher scores indicate more severe psoriasis. (NCT02749370)
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24

Static Physician Global Assessment (sPGA) at Each Visit

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). (NCT02749370)
Timeframe: Weeks 4, 8, 12, 16, 20, and 24

Pustules Count Percent Change From Baseline

Percentage change from baseline in Pustules count after 20 weeks of treatment with Apremilast (NCT04572997)
Timeframe: At Visit 2 (Baseline) and Visit 5 (End of Study - Week 20)

Dermatology Life Quality Index (DLQI)

"The DLQI is a dermatology-specific quality of life instrument designed to assess the impact of a disease on the patient's daily life which is also validated for PPP. It is a 10-item questionnaire and can be used to assess 6 different aspects: symptoms and feelings, leisure, daily activities, work or school performance, personal relationship and treatment. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired.~Meaning of DLQI scores:~0 to 1 = No effect at all on patient's life~2 to 5 = Small effect on patient's life~6 to 10 = Moderate effect on patient's life~11 to 20 = Very large effect on patient's life~21 to 30 = Extremely large effect on patient's life" (NCT04572997)
Timeframe: At Visit 2 (Baseline), Visit 4 (Week 12) and Visit 5 (Week 20).

Number of Participants With PPPASI 50 Response

PPPASI 50 response defined as a 50% decrease in PPPASI from baseline. (NCT04572997)
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 20).

Number of Participants With PPPASI 75 Response

PPPASI 75 response defined as a 75% decrease in PPPASI from baseline. (NCT04572997)
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 20).

Number of Participants With Pustules Count 50 and 75 Response

Patients experiencing a 50% and 75% decrease in Pustules count from baseline (NCT04572997)
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study-Week 20).

Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) at Week 20 Compared With Baseline

The PPPASI assess palms of hands and soles of feet for psoriasis involvement. The PPPASI score range from 0-72, with higher scores indicating more severe disease. (NCT04572997)
Timeframe: PPPASI Score at baseline and Week 20.

Psoriasis Area and Severity Index (PASI)

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. (NCT04572997)
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).

Visual Analogue Scale (VAS) Discomfort/Pain

VAS was used to assess discomfort/pain. The patient was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary represented no discomfort/pain (at 0 mm), and the right-hand boundary (at 100 mm) represented discomfort/pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded, with higher values indicating more discomfort/pain (worse conditions). (NCT04572997)
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).

Visual Analogue Scale (VAS) Pruritus/Itch

VAS was used to assess pruritus/itch. The patient was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary (at 0 mm) represented no pruritus/itch, and the right-hand boundary (at 100 mm) represented pruritus/itch as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded, with higher values indicating more pruritus/itch (worse outcomes). (NCT04572997)
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).

Dynamic H&F PGA

The dynamic H&F PGA describes the global improvement compared with baseline. It relies on the physician's memory of the baseline severity to evaluate the level of alteration. The categories vary between 0 (cleared) and 6 (worse). (NCT04572997)
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).

Hand and Feet Physician Global Assessment (H&F PGA)

The H&F PGA describes the severity of psoriasis on the hands and/or feet using five categories ranging from 0 (clear) to 4 (severe). (NCT04572997)
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4) , Visit 4 (Week 12) and Visit 5 (Week 20).

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

"DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best." (NCT01232283)
Timeframe: Baseline and Week 16

Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16

The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value - baseline value. (NCT01232283)
Timeframe: Baseline and Week 16

Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16

"The SF-36 was a 36-item general health instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS).~Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value." (NCT01232283)
Timeframe: Baseline to Week 16