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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.
Excerpt | Relevance | Reference |
---|---|---|
"Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis." | 9.24 | 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). ( 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." | 9.24 | 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). ( 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." | 6.84 | 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. ( 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." | 5.24 | 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). ( 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." | 5.24 | 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). ( 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." | 2.84 | 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. ( Chen, P; Day, RM; Imafuku, S; Komine, M; Maroli, A; Nemoto, O; Ohtsuki, M; Okubo, Y; Petric, R, 2017) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 3 (100.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Ohtsuki, M | 1 |
Okubo, Y | 1 |
Komine, M | 1 |
Imafuku, S | 1 |
Day, RM | 3 |
Chen, P | 1 |
Petric, R | 1 |
Maroli, A | 1 |
Nemoto, O | 1 |
Crowley, J | 1 |
Thaçi, D | 1 |
Joly, P | 1 |
Peris, K | 1 |
Papp, KA | 1 |
Goncalves, J | 2 |
Chen, R | 1 |
Shah, K | 2 |
Ferrándiz, C | 1 |
Cather, JC | 1 |
Reich, K | 1 |
Gooderham, M | 1 |
Green, L | 1 |
Bewley, A | 1 |
Zhang, Z | 1 |
Khanskaya, I | 1 |
Piguet, V | 1 |
Soung, J | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
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 2 | 254 participants (Actual) | Interventional | 2013-07-09 | Completed | ||
A Pilot Study to Evaluate the Efficacy and Safety of Apremilast in Patients of Chronic and Recurrent Erythema Nodosum Leprosum[NCT04822909] | Phase 4 | 10 participants (Actual) | Interventional | 2019-09-15 | Completed | ||
Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis[NCT06032858] | Phase 4 | 30 participants (Actual) | Interventional | 2022-03-06 | Completed | ||
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 3 | 250 participants (Actual) | Interventional | 2012-10-01 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
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
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | -1.59 |
Apremilast 20mg | -0.71 |
Apremilast 30mg | 0.27 |
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
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | 7.1 |
Apremilast 20mg | -7.5 |
Apremilast 30mg | -17.7 |
"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
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | 1.3 |
Apremilast 20mg | -0.5 |
Apremilast 30mg | -2.2 |
"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
Intervention | percent change (Least Squares Mean) |
---|---|
Placebo | 7.5 |
Apremilast 20mg | -21.6 |
Apremilast 30mg | -30.5 |
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
Intervention | percent change (Least Squares Mean) |
---|---|
Placebo | -3.7 |
Apremilast 20mg | -33.1 |
Apremilast 30mg | -43.1 |
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
Intervention | percentage of participants (Number) |
---|---|
Placebo | 21.4 |
Apremilast 20mg | 41.2 |
Apremilast 30mg | 50.6 |
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
Intervention | percentage of participants (Number) |
---|---|
Placebo | 7.1 |
Apremilast 20mg | 23.5 |
Apremilast 30mg | 28.2 |
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
Intervention | percentage of participants (Number) |
---|---|
Placebo | 8.8 |
Apremilast 20mg | 23.9 |
Apremilast 30mg | 29.6 |
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.
Intervention | participants (Number) | |||||||
---|---|---|---|---|---|---|---|---|
≥ At Least 1 TEAE | ≥ 1 Drug-related TEAR | ≥ At Least 1 Severe TEAE | ≥ 1 Serious TEAE | Any Serious Drug-related TEAE | ≥ 1 TEAE leading to Drug Interruption | ≥ 1 TEAE Leading to Drug Withdrawal | ≥ 1 TEAE Leading to Death | |
Apremilast 20mg | 94 | 34 | 12 | 11 | 5 | 6 | 19 | 1 |
Apremilast 30mg | 89 | 37 | 2 | 2 | 0 | 2 | 10 | 0 |
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
Intervention | participants (Number) | |||||||
---|---|---|---|---|---|---|---|---|
≥ At least 1 TEAE | ≥ 1 Drug-related TEAE | ≥ At least 1 Severe TEAE | ≥ 1 Serious TEAE | Any Serious Drug-related TEAE | ≥ 1 TEAE leading to Drug Interruption | ≥ 1 TEAE Leading to Drug Withdrawal | ≥ 1 TEAE Leading to Death | |
Apremilast 20mg | 49 | 18 | 4 | 4 | 2 | 2 | 10 | 0 |
Apremilast 30mg | 44 | 25 | 0 | 0 | 0 | 0 | 6 | 0 |
Placebo | 35 | 8 | 1 | 0 | 0 | 2 | 4 | 0 |
"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
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | -3.9 |
Apremilast 30mg Plus Placebo Injection | -8.4 |
Etanercept 50mg Plus Placebo Tablet | -7.8 |
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
Intervention | units on a scale (Least Squares Mean) |
---|---|
Placebo | 2.6 |
Apremilast Plus Placebo Injection | 3.5 |
Etanercept Plus Placebo Tablets | 4.8 |
"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
Intervention | percent change (Least Squares Mean) |
---|---|
Placebo | -16.3 |
Apremilast Plus Placebo Injection | -47.7 |
Etanercept Plus Placebo Tablets | -56.1 |
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
Intervention | percentage of participants (Number) |
---|---|
Placebo | 33.3 |
Apremilast Plus Placebo Injection | 62.7 |
Etanercept Plus Placebo Tablet | 83.1 |
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
Intervention | percentage of participants (Number) |
---|---|
Placebo | 11.9 |
Etanercept 50mg Plus Placebo Tablet | 48.2 |
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
Intervention | Percentage of participants (Number) |
---|---|
Placebo | 11.9 |
Apremilast Plus Placebo Injection | 39.8 |
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
Intervention | percentage of participants (Number) |
---|---|
Placebo | 6.0 |
Apremilast Plus Placebo Injection | 24.1 |
Etanercept Plus Placebo Tablets | 22.9 |
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
Intervention | percentage of participants (Number) |
---|---|
Placebo | 3.6 |
Apremilast Plus Placebo Injection | 21.7 |
Etanercept Plus Placebo Tablet | 28.9 |
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
Intervention | participants (Number) | |||||||
---|---|---|---|---|---|---|---|---|
Any TEAE | Any Drug-related TEAE | Any Severe TEAE | Any Serious TEAE | Any Serious Drug-related TEAE | Any TEAE Leading to Drug Interruption | Any TEAE Leading to Drug Withdrawal | Any TEAE Leading to Death | |
Apremilast/Apremilast | 71 | 36 | 7 | 6 | 2 | 13 | 7 | 0 |
Etanercept/Apremilast | 54 | 15 | 7 | 4 | 1 | 7 | 2 | 0 |
Placebo/Apremilast | 45 | 23 | 4 | 5 | 2 | 8 | 3 | 0 |
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
Intervention | participants (Number) | |||||||
---|---|---|---|---|---|---|---|---|
Any TEAE | Any Drug-related TEAE | Any Severe TEAE | Any Serious TEAE | Any Serious Drug-related TEAE | Any TEAE Leading to Drug Interruption | Any TEAE Leading to Drug Withdrawal | Any TEAE Leading to Death | |
Apremilast Plus Placebo Injection | 59 | 27 | 3 | 3 | 2 | 9 | 3 | 0 |
Etanercept Plus Placebo Tablets | 44 | 21 | 3 | 2 | 1 | 3 | 2 | 0 |
Placebo | 45 | 17 | 2 | 0 | 0 | 1 | 2 | 0 |
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
Intervention | participants (Number) | ||
---|---|---|---|
Any psoriasis flare captured as a TEAE | Any psoriasis rebound captured as a TEAE | Those with PASI ≥125% baseline score and D/C APR | |
Apremilast Plus Placebo Injection | 1 | 0 | 0 |
Etanercept Plus Placebo Tablets | 0 | 0 | 0 |
Placebo | 3 | 0 | 1 |
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.
Intervention | participants (Number) | ||
---|---|---|---|
Any psoriasis flare captured as a TEAE | Any psoriasis rebound captured as a TEAE | Those with PASI ≥125% baseline score and D/C APR | |
Apremilast/Apremilast | 4 | 2 | 0 |
Etanercept/Apremilast | 0 | 7 | 1 |
Placebo/Apremilast | 1 | 1 | 0 |
3 trials available for thalidomide and Nasopharyngitis
Article | Year |
---|---|
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.
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).
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).
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).
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).
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).
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Diarrhea; Double-Blind Method; Etanercept; Female; H | 2017 |