Page last updated: 2024-11-05

thalidomide and Nasopharyngitis

thalidomide has been researched along with Nasopharyngitis in 3 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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.

Nasopharyngitis: Inflammation of the NASOPHARYNX, usually including its mucosa, related lymphoid structure, and glands.

Research Excerpts

ExcerptRelevanceReference
"Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis."9.24Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). ( Cather, JC; Chen, R; Crowley, J; Day, RM; Ferrándiz, C; Goncalves, J; Joly, P; Papp, KA; Peris, K; Shah, K; Thaçi, D, 2017)
"Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate-to-severe psoriasis."9.24The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE). ( Bewley, A; Day, RM; Goncalves, J; Gooderham, M; Green, L; Khanskaya, I; Piguet, V; Reich, K; Shah, K; Soung, J; Zhang, Z, 2017)
" Most common adverse events (AEs) with placebo, apremilast 20 and apremilast 30 (0-16 weeks) were nasopharyngitis (8."6.84Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy, safety and tolerability results from a phase 2b randomized controlled trial. ( Chen, P; Day, RM; Imafuku, S; Komine, M; Maroli, A; Nemoto, O; Ohtsuki, M; Okubo, Y; Petric, R, 2017)
"Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis."5.24Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). ( Cather, JC; Chen, R; Crowley, J; Day, RM; Ferrándiz, C; Goncalves, J; Joly, P; Papp, KA; Peris, K; Shah, K; Thaçi, D, 2017)
"Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate-to-severe psoriasis."5.24The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE). ( Bewley, A; Day, RM; Goncalves, J; Gooderham, M; Green, L; Khanskaya, I; Piguet, V; Reich, K; Shah, K; Soung, J; Zhang, Z, 2017)
" Most common adverse events (AEs) with placebo, apremilast 20 and apremilast 30 (0-16 weeks) were nasopharyngitis (8."2.84Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy, safety and tolerability results from a phase 2b randomized controlled trial. ( Chen, P; Day, RM; Imafuku, S; Komine, M; Maroli, A; Nemoto, O; Ohtsuki, M; Okubo, Y; Petric, R, 2017)

Research

Studies (3)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's3 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Ohtsuki, M1
Okubo, Y1
Komine, M1
Imafuku, S1
Day, RM3
Chen, P1
Petric, R1
Maroli, A1
Nemoto, O1
Crowley, J1
Thaçi, D1
Joly, P1
Peris, K1
Papp, KA1
Goncalves, J2
Chen, R1
Shah, K2
Ferrándiz, C1
Cather, JC1
Reich, K1
Gooderham, M1
Green, L1
Bewley, A1
Zhang, Z1
Khanskaya, I1
Piguet, V1
Soung, J1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Subjects With Moderate-To-Severe Plaque-Type Psoriasis[NCT01988103]Phase 2254 participants (Actual)Interventional2013-07-09Completed
A Pilot Study to Evaluate the Efficacy and Safety of Apremilast in Patients of Chronic and Recurrent Erythema Nodosum Leprosum[NCT04822909]Phase 410 participants (Actual)Interventional2019-09-15Completed
Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis[NCT06032858]Phase 430 participants (Actual)Interventional2022-03-06Completed
A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast (CC-10004), Etanercept, And Placebo, In Subjects With Moderate To Severe Plaque Psoriasis[NCT01690299]Phase 3250 participants (Actual)Interventional2012-10-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

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

SF-36 is a 36-item general health status instrument often used in clinical trials and health services research. It 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 quality of life (better functioning) (NCT01988103)
Timeframe: Baseline to Week 16

Interventionunits on a scale (Least Squares Mean)
Placebo-1.59
Apremilast 20mg-0.71
Apremilast 30mg0.27

Change From Baseline in Pruritus Visual Analogue Scale 100-mm (VAS) at Week 16

The pruritus visual analog scale (VAS) was 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? Higher scores correspond to more severe symptom or disease. The participant places a vertical line on a 100-mm VAS on which the left-hand boundary represents no itch at all and the right-hand boundary represents the worst itch imaginable. The distance from the vertical line to the left-hand boundary is recorded. VAS scores range from 0 to 100 mm, where higher scores correspond to worse pruritis (itch). (NCT01988103)
Timeframe: Baseline to Week 16

Interventionunits on a scale (Least Squares Mean)
Placebo7.1
Apremilast 20mg-7.5
Apremilast 30mg-17.7

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

"Dermatology Life Quality Index (DLQI) was developed as a practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains 10 items dealing with the participants 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 participant 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 has a possible range from 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best." (NCT01988103)
Timeframe: Baseline to Week 16

Interventionunits on a scale (Least Squares Mean)
Placebo1.3
Apremilast 20mg-0.5
Apremilast 30mg-2.2

Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) at Week 16

"BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the subject's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area." (NCT01988103)
Timeframe: Baseline to Week 16

Interventionpercent change (Least Squares Mean)
Placebo7.5
Apremilast 20mg-21.6
Apremilast 30mg-30.5

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

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. The PASI is a validated instrument that has become standard in clinical trials for psoriasis. The PASI scores range from 0 to 72, with higher scores reflecting a greater disease severity. (NCT01988103)
Timeframe: Baseline to Week 16

Interventionpercent change (Least Squares Mean)
Placebo-3.7
Apremilast 20mg-33.1
Apremilast 30mg-43.1

Percentage of Participants Who Achieved a 50% Improvement From Baseline (Response) Reduction in the PASI-50 at Week 16

PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was 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 PASI score was set to missing if any severity score or degree of involvement is missing. (NCT01988103)
Timeframe: Baseline to Week 16

Interventionpercentage of participants (Number)
Placebo21.4
Apremilast 20mg41.2
Apremilast 30mg50.6

Percentage of Participants Who Achieved a 75% Improvement (Response) From Baseline in the Psoriasis Area and Severity Index (PASI-75) at Week 16

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was 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 PASI score was set to missing if any severity score or degree of involvement was missing. (NCT01988103)
Timeframe: Baseline to Week 16

Interventionpercentage of participants (Number)
Placebo7.1
Apremilast 20mg23.5
Apremilast 30mg28.2

Percentage of Participants Who Achieved a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Point Reduction From Baseline to Week 16

The sPGA is a measure of psoriasis disease severity at the time of evaluation by the Investigator. It does not compare assessments across visits or rely on investigator recall or prior disease. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equals the overall sPGA score. (NCT01988103)
Timeframe: Baseline to Week 16

Interventionpercentage of participants (Number)
Placebo8.8
Apremilast 20mg23.9
Apremilast 30mg29.6

Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period

An AE was any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose. (NCT01988103)
Timeframe: From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo who were re-randomized at Week 16) until 28 days after the last dose of apremilast.

,
Interventionparticipants (Number)
≥ At Least 1 TEAE≥ 1 Drug-related TEAR≥ At Least 1 Severe TEAE≥ 1 Serious TEAEAny Serious Drug-related TEAE≥ 1 TEAE leading to Drug Interruption≥ 1 TEAE Leading to Drug Withdrawal≥ 1 TEAE Leading to Death
Apremilast 20mg9434121156191
Apremilast 30mg89372202100

Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase

An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose. (NCT01988103)
Timeframe: Baseline to Week 16

,,
Interventionparticipants (Number)
≥ At least 1 TEAE≥ 1 Drug-related TEAE≥ At least 1 Severe TEAE≥ 1 Serious TEAEAny Serious Drug-related TEAE≥ 1 TEAE leading to Drug Interruption≥ 1 TEAE Leading to Drug Withdrawal≥ 1 TEAE Leading to Death
Apremilast 20mg49184422100
Apremilast 30mg4425000060
Placebo358100240

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo 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 participant 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 is 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." (NCT01690299)
Timeframe: Baseline to Week 16

Interventionunits on a scale (Least Squares Mean)
Placebo-3.9
Apremilast 30mg Plus Placebo Injection-8.4
Etanercept 50mg Plus Placebo Tablet-7.8

Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16

The SF-36 is a 36-item general health status 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. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value - baseline value. (NCT01690299)
Timeframe: Baseline to Week 16

Interventionunits on a scale (Least Squares Mean)
Placebo2.6
Apremilast Plus Placebo Injection3.5
Etanercept Plus Placebo Tablets4.8

Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16

"BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100*(post-baseline BSA - baseline BSA) / baseline BSA." (NCT01690299)
Timeframe: Baseline to Week 16

Interventionpercent change (Least Squares Mean)
Placebo-16.3
Apremilast Plus Placebo Injection-47.7
Etanercept Plus Placebo Tablets-56.1

Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16

PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The PASI score was 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 PASI score was set to missing if any severity score or degree of involvement was missing. (NCT01690299)
Timeframe: Baseline to Week 16

Interventionpercentage of participants (Number)
Placebo33.3
Apremilast Plus Placebo Injection62.7
Etanercept Plus Placebo Tablet83.1

Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was 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 PASI score was set to missing if any severity score or degree of involvement was missing. (NCT01690299)
Timeframe: Baseline and Week 16

Interventionpercentage of participants (Number)
Placebo11.9
Etanercept 50mg Plus Placebo Tablet48.2

Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline

PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was 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 PASI score was set to missing if any severity score or degree of involvement was missing. (NCT01690299)
Timeframe: Baseline to Week 16

InterventionPercentage of participants (Number)
Placebo11.9
Apremilast Plus Placebo Injection39.8

Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16

The Lattice System Physician's Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least. (NCT01690299)
Timeframe: Baseline to Week 16

Interventionpercentage of participants (Number)
Placebo6.0
Apremilast Plus Placebo Injection24.1
Etanercept Plus Placebo Tablets22.9

Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16

The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score. (NCT01690299)
Timeframe: Baseline and Week 16

Interventionpercentage of participants (Number)
Placebo3.6
Apremilast Plus Placebo Injection21.7
Etanercept Plus Placebo Tablet28.9

Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period

A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the 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. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above. (NCT01690299)
Timeframe: From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose

,,
Interventionparticipants (Number)
Any TEAEAny Drug-related TEAEAny Severe TEAEAny Serious TEAEAny Serious Drug-related TEAEAny TEAE Leading to Drug InterruptionAny TEAE Leading to Drug WithdrawalAny TEAE Leading to Death
Apremilast/Apremilast71367621370
Etanercept/Apremilast5415741720
Placebo/Apremilast4523452830

Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase

A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. (NCT01690299)
Timeframe: Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group

,,
Interventionparticipants (Number)
Any TEAEAny Drug-related TEAEAny Severe TEAEAny Serious TEAEAny Serious Drug-related TEAEAny TEAE Leading to Drug InterruptionAny TEAE Leading to Drug WithdrawalAny TEAE Leading to Death
Apremilast Plus Placebo Injection5927332930
Etanercept Plus Placebo Tablets4421321320
Placebo4517200120

Psoriasis Flare/Rebound

Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. (NCT01690299)
Timeframe: Week 0 to Week 16; Placebo controlled phase

,,
Interventionparticipants (Number)
Any psoriasis flare captured as a TEAEAny psoriasis rebound captured as a TEAEThose with PASI ≥125% baseline score and D/C APR
Apremilast Plus Placebo Injection100
Etanercept Plus Placebo Tablets000
Placebo301

Psoriasis Flare/Rebound

Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase. (NCT01690299)
Timeframe: From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast.

,,
Interventionparticipants (Number)
Any psoriasis flare captured as a TEAEAny psoriasis rebound captured as a TEAEThose with PASI ≥125% baseline score and D/C APR
Apremilast/Apremilast420
Etanercept/Apremilast071
Placebo/Apremilast110

Trials

3 trials available for thalidomide and Nasopharyngitis

ArticleYear
Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy, safety and tolerability results from a phase 2b randomized controlled trial.
    The Journal of dermatology, 2017, Volume: 44, Issue:8

    Topics: Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Diarrhea; Dose-Response Relati

2017
Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2).
    Journal of the American Academy of Dermatology, 2017, Volume: 77, Issue:2

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Diseases; Depression; Diarrhea; Femal

2017
Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2).
    Journal of the American Academy of Dermatology, 2017, Volume: 77, Issue:2

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Diseases; Depression; Diarrhea; Femal

2017
Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2).
    Journal of the American Academy of Dermatology, 2017, Volume: 77, Issue:2

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Diseases; Depression; Diarrhea; Femal

2017
Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2).
    Journal of the American Academy of Dermatology, 2017, Volume: 77, Issue:2

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Diseases; Depression; Diarrhea; Femal

2017
The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE).
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2017, Volume: 31, Issue:3

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Diarrhea; Double-Blind Method; Etanercept; Female; H

2017