Page last updated: 2024-11-05

thalidomide and Bilateral Headache

thalidomide has been researched along with Bilateral Headache in 16 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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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 Excerpts

ExcerptRelevanceReference
"Adults (≥18 years of age) with moderate to severe plaque psoriasis (baseline PGA ≥3, BSA affected ≥10%, PASI ≥12) took oral apremilast (30 mg twice daily) for 8 weeks."9.34Apremilast with Add-On Calcipotriene/Betamethasone Dipropionate for Treating Moderate to Severe Plaque Psoriasis. ( Bagel, J; Hetzel, A; Nelson, E; Riley, C, 2020)
"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)
"This phase II study evaluated the combination of semaxanib, a small molecule tyrosine kinase inhibitor of vascular endothelial growth factor (VEGF) receptor-2, and thalidomide in patients with metastatic melanoma to assess the efficacy, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the combination."9.12A phase II, pharmacokinetic, and biologic study of semaxanib and thalidomide in patients with metastatic melanoma. ( Beeram, M; Berg, K; de Bono, JS; Eckhart, SG; Forero, L; Hammond, LA; Izbicka, E; Mita, AC; Mita, MM; Patnaik, A; Rowinsky, EK; Simmons, P; Takimoto, C; Tolcher, AW; Weiss, GR, 2007)
"To review the pharmacology, efficacy, and safety of apremilast and determine its role relative to other agents in the treatment of psoriasis and psoriatic arthritis."8.93Apremilast: A Novel Drug for Treatment of Psoriasis and Psoriatic Arthritis. ( Bank, M; Haber, SL; Hamilton, S; Leong, SY; Pierce, E, 2016)
"Apremilast is a novel oral phosphodiesterase-4 inhibitor approved for psoriasis treatment."7.88Apremilast in psoriasis - a prospective real-world study. ( Herman, R; Monshi, B; Posch, C; Rappersberger, K; Richter, L; Sanlorenzo, M; Vujic, I, 2018)
"Apremilast is a novel oral phosphodiesterase 4 inhibitor effective for psoriasis."7.88Real-world use of apremilast for patients with psoriasis in Japan. ( Hioki, T; Kamiya, K; Kishimoto, M; Komine, M; Ohtsuki, M; Sugai, J, 2018)
" The most common adverse events (≥5% of patients) through week 52 were diarrhea (28."6.87Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL. ( Bagel, J; Chen, R; Duffin, KC; Goncalves, J; Jackson, JM; Lebwohl, M; Levi, E; Stein Gold, L, 2018)
"Thalidomide was well tolerated: the most common side effects were constipation (76."6.71Thalidomide prolongs disease stabilization after conventional therapy in patients with recurrent glioblastoma. ( Carillio, G; Fanelli, M; Gasparini, G; Gattuso, D; Morabito, A; Sarmiento, R, 2004)
"Adults (≥18 years of age) with moderate to severe plaque psoriasis (baseline PGA ≥3, BSA affected ≥10%, PASI ≥12) took oral apremilast (30 mg twice daily) for 8 weeks."5.34Apremilast with Add-On Calcipotriene/Betamethasone Dipropionate for Treating Moderate to Severe Plaque Psoriasis. ( Bagel, J; Hetzel, A; Nelson, E; Riley, C, 2020)
"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)
"This phase II study evaluated the combination of semaxanib, a small molecule tyrosine kinase inhibitor of vascular endothelial growth factor (VEGF) receptor-2, and thalidomide in patients with metastatic melanoma to assess the efficacy, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the combination."5.12A phase II, pharmacokinetic, and biologic study of semaxanib and thalidomide in patients with metastatic melanoma. ( Beeram, M; Berg, K; de Bono, JS; Eckhart, SG; Forero, L; Hammond, LA; Izbicka, E; Mita, AC; Mita, MM; Patnaik, A; Rowinsky, EK; Simmons, P; Takimoto, C; Tolcher, AW; Weiss, GR, 2007)
"To review the pharmacology, efficacy, and safety of apremilast and determine its role relative to other agents in the treatment of psoriasis and psoriatic arthritis."4.93Apremilast: A Novel Drug for Treatment of Psoriasis and Psoriatic Arthritis. ( Bank, M; Haber, SL; Hamilton, S; Leong, SY; Pierce, E, 2016)
"We present a series of general and specific recommendations based on pathophysiologic considerations for managing the most common adverse effects of apremilast that lead to treatment discontinuation: diarrhea, nausea, and headache."4.02Multidisciplinary Management of the Adverse Effects of Apremilast. ( Alonso Suárez, J; Beltrán Catalán, E; Blasco Maldonado, C; Daudén Tello, E; García-Merino, A; Herrero Manso, MC; Jiménez Morales, A; Marín-Jiménez, I; Martín-Arranz, MD; Porta Etessam, J; Rodríguez-Sagrado, MA; Rosas Gómez de Salazar, J; Salgado-Boquete, L; Trujillo Martín, E, 2021)
"Apremilast is a novel oral phosphodiesterase-4 inhibitor approved for psoriasis treatment."3.88Apremilast in psoriasis - a prospective real-world study. ( Herman, R; Monshi, B; Posch, C; Rappersberger, K; Richter, L; Sanlorenzo, M; Vujic, I, 2018)
"Apremilast is a novel oral phosphodiesterase 4 inhibitor effective for psoriasis."3.88Real-world use of apremilast for patients with psoriasis in Japan. ( Hioki, T; Kamiya, K; Kishimoto, M; Komine, M; Ohtsuki, M; Sugai, J, 2018)
" The most common adverse events (≥5% of patients) through week 52 were diarrhea (28."2.87Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL. ( Bagel, J; Chen, R; Duffin, KC; Goncalves, J; Jackson, JM; Lebwohl, M; Levi, E; Stein Gold, L, 2018)
"Apremilast is a novel oral PDE4 enzyme inhibitor capable of blocking leukocyte production of IL-12, IL-23, TNF-a, INF- with subsequent suppression of Th1 and Th17-mediated immune responses, and proven clinical efficacy for psoriasis as well as rheumatoid and psoriatic arthritis."2.77Apremilast for discoid lupus erythematosus: results of a phase 2, open-label, single-arm, pilot study. ( De Souza, A; Franks, AG; Merola, JF; Oliver, S; Strober, BE, 2012)
"Thalidomide was well tolerated: the most common side effects were constipation (76."2.71Thalidomide prolongs disease stabilization after conventional therapy in patients with recurrent glioblastoma. ( Carillio, G; Fanelli, M; Gasparini, G; Gattuso, D; Morabito, A; Sarmiento, R, 2004)

Research

Studies (16)

TimeframeStudies, this research(%)All Research%
pre-19901 (6.25)18.7374
1990's0 (0.00)18.2507
2000's3 (18.75)29.6817
2010's10 (62.50)24.3611
2020's2 (12.50)2.80

Authors

AuthorsStudies
Daudén Tello, E1
Alonso Suárez, J1
Beltrán Catalán, E1
Blasco Maldonado, C1
Herrero Manso, MC1
Jiménez Morales, A1
Marín-Jiménez, I1
Martín-Arranz, MD1
García-Merino, A1
Porta Etessam, J1
Rodríguez-Sagrado, MA1
Rosas Gómez de Salazar, J1
Trujillo Martín, E1
Salgado-Boquete, L1
Bagel, J2
Nelson, E1
Riley, C1
Hetzel, A1
Jolobe, OM1
Crowley, J1
Thaçi, D1
Joly, P1
Peris, K1
Papp, KA1
Goncalves, J3
Day, RM2
Chen, R2
Shah, K2
Ferrándiz, C1
Cather, JC1
Vujic, I1
Herman, R1
Sanlorenzo, M1
Posch, C1
Monshi, B1
Rappersberger, K1
Richter, L1
Stein Gold, L1
Lebwohl, M1
Jackson, JM1
Levi, E1
Duffin, KC1
Lee, EB1
Amin, M1
Egeberg, A1
Wu, JJ1
Ighani, A1
Georgakopoulos, JR1
Shear, NH1
Walsh, S1
Yeung, J1
Kishimoto, M1
Komine, M1
Hioki, T1
Kamiya, K1
Sugai, J1
Ohtsuki, M1
Haber, SL1
Hamilton, S1
Bank, M1
Leong, SY1
Pierce, E1
Reich, K1
Gooderham, M1
Green, L1
Bewley, A1
Zhang, Z1
Khanskaya, I1
Piguet, V1
Soung, J1
Phan, A1
Favrole, P1
Alamowitch, S1
Chosidow, O1
De Souza, A1
Strober, BE1
Merola, JF1
Oliver, S1
Franks, AG1
SKRE, H1
Morabito, A1
Fanelli, M1
Carillio, G1
Gattuso, D1
Sarmiento, R1
Gasparini, G1
Mita, MM1
Rowinsky, EK1
Forero, L1
Eckhart, SG1
Izbicka, E1
Weiss, GR1
Beeram, M1
Mita, AC1
de Bono, JS1
Tolcher, AW1
Hammond, LA1
Simmons, P1
Berg, K1
Takimoto, C1
Patnaik, A1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate Plaque Psoriasis[NCT02425826]Phase 4221 participants (Actual)Interventional2015-04-20Completed
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

Mean Change From Baseline in the 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 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." (NCT02425826)
Timeframe: Baseline to Week 16 (end of phase)

Interventionunits on a scale (Mean)
Placebo-2.4
Apremilast-4.8

Mean Percentage Change From Baseline in Psoriasis Area Severity Index Score (PASI) at Week 16

The PASI score 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. 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). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. (NCT02425826)
Timeframe: Baseline to Week 16 (end of phase)

Interventionpercentage change (Mean)
Placebo-3.87
Apremilast-40.72

Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index 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 participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score. The range of BSA*sPGA mean percentage change from baseline to week 16 (end of phase) were -100 to 344.4 and -100 to 100 for the placebo and apremilast groups respectively. Higher scores represented worse outcomes." (NCT02425826)
Timeframe: Baseline to Week 16 (end of phase)

Interventionpercentage change (Mean)
Placebo-10.17
Apremilast-48.07

Mean Percentage Change From Baseline in the Product of BSA (%) x sPGA at Week 52

"BSA is a measurement of involved skin. The overall BSA affected by psoriasis is 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. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score." (NCT02425826)
Timeframe: Baseline to Week 52

Interventionpercentage change (Mean)
Placebo-Apremilast-42.23
Apremilast-55.45

Percentage of Participants Who Achieved a Clear (0) or Very Mild (1) on Patient Global Assessment (PtGA) Scale at Week 16 From Baseline

The PtGA response rate is defined as the percentage of participants achieving 0 (clear) or 1 (very mild) on the PtGA scale at Week 16. The PtGA is the assessment by the participant of the overall disease severity at the time of evaluation. The PtGA is a 5-point scale ranging from 0 (clear) to 4 (severe). (NCT02425826)
Timeframe: Baseline to Week 16 (end of phase)

Interventionpercentage of participants (Number)
Placebo20.5
Apremilast33.8

Percentage of Participants Who Achieved a sPGA Score of Clear (0) or Almost Clear (1) at Week 16 From Baseline

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 6-point scale, ranging from 0 (clear) to 5 (very severe), with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are averaged and rounded to the nearest whole number to result in the final sPGA score. (NCT02425826)
Timeframe: Baseline to Week 16 (end of phase)

Interventionpercentage of participants (Number)
Placebo9.6
Apremilast30.4

Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline at Week 16.

The PASI score 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. 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). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. (NCT02425826)
Timeframe: Baseline to Week 16 (end of phase)

Interventionpercentage of participants (Number)
Placebo24.7
Apremilast53.4

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

The PASI score 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. 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). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. (NCT02425826)
Timeframe: Baseline to Week 16 (end of phase)

Interventionpercentage of participants (Number)
Placebo8.2
Apremilast21.6

Percentage of Participants With Scalp Psoriasis Who Achieved a Clear (0) or Minimal (1) on Scalp Physician's Global Assessment (ScPGA) Scale at Week 16.

The ScPGA assessed scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment. Scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA was restricted to the participants with scalp involvement at baseline. (NCT02425826)
Timeframe: Baseline to Week 16 (end of phase)

Interventionpercentage of participants (Number)
Placebo38.2
Apremilast50.0

Mean Change From Baseline in Pruritus Visual Analog Scale (VAS)

The Pruritus VAS assessment was conducted at the baseline visit and each post-baseline visit. The participant was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary (0) represents no itch, and the right-hand boundary (100) represents itch as severe as can be imagined. The distance from the mark to the left-hand boundary will be recorded. The Pruritus VAS score ranges from 0 to 100. Higher scores correspond to more severe symptom. (NCT02425826)
Timeframe: Baseline to Weeks 1 and 16 (end of phase)

,
Interventionunits on a scale (Mean)
Week 1Week 16
Apremilast-13.9-19.2
Placebo-9.6-10.2

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase

Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. 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/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. (NCT02425826)
Timeframe: Date of first dose of apremilast during the placebo controlled phase or date of first dose of apremilast after week 16; overall maximum duration of exposure was 61.5 weeks during apremilast-exposure phase

Interventionparticipants (Number)
≥ At Least 1 TEAE≥ 1 Drug-related TEAE≥ At Least 1 Severe TEAE≥ At Least 1 Serious TEAE≥ 1 Serious Drug-related TEAE≥ 1 TEAE leading to drug withdrawal≥ 1 TEAE Leading to drug interruptionAny TEAE leading to death
Apremilast14298510114270

Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase

Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. 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/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. (NCT02425826)
Timeframe: From first dose of study drug to Week 16; maximum duration of exposure was 20.1 weeks during placebo controlled phase

,
Interventionparticipants (Number)
≥ At Least 1 TEAE≥ 1 Drug-related TEAE≥ At Least 1 Severe TEAE≥ At Least 1 Serious TEAE≥ 1 Serious Drug-related TEAE≥ 1 TEAE leading to drug withdrawal≥ 1 TEAE Leading to drug interruptionAny TEAE leading to death
Apremilast9271330590
Placebo3521100330

Percentage of Participants With Scalp Psoriasis Who Were Initially Randomized to Apremilast and Maintained the Scalp Physician's Global Assessment (ScPGA) Response From Week 16 to Week 52.

The ScPGA will assess scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment with scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA is restricted to the participants with scalp involvement at baseline. (NCT02425826)
Timeframe: Week 16 to Week 52

Interventionpercentage of participants (Number)
Responder status at Week 16Responder status maintained at Week 52
Apremilast50.080.4

Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16

The TSQM version II is an 11-question self-administered instrument to understand a participation's satisfaction with the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score mean indicates higher satisfaction with treatment. (NCT02425826)
Timeframe: Baseline to Week 16 (end of phase)

,
Interventionunits on a scale (Mean)
TSQM-EffectivenessTSQM-Side EffectsTSQM-ConvenienceTSQM-Global Satisfaction
Apremilast57.2578.5066.9363.24
Placebo38.8175.0065.6848.74

Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52

The TSQM version II is an 11-question self-administered instrument to understand a participants satisfaction on the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score indicates higher satisfaction with treatment. (NCT02425826)
Timeframe: Baseline to week 52

,
Interventionunits on a scale (Mean)
TSQM-EffectivenessTSQM-Side EffectsTSQM-ConvenienceTSQM-Global Satisfaction
Apremilast54.1375.4571.7659.92
Placebo-Apremilast57.6877.2972.7459.24

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

Reviews

1 review available for thalidomide and Bilateral Headache

ArticleYear
Apremilast: A Novel Drug for Treatment of Psoriasis and Psoriatic Arthritis.
    The Annals of pharmacotherapy, 2016, Volume: 50, Issue:4

    Topics: Antirheumatic Agents; Arthritis, Psoriatic; Diarrhea; Headache; Humans; Nausea; Psoriasis; Thalidomi

2016

Trials

7 trials available for thalidomide and Bilateral Headache

ArticleYear
Apremilast with Add-On Calcipotriene/Betamethasone Dipropionate for Treating Moderate to Severe Plaque Psoriasis.
    Journal of drugs in dermatology : JDD, 2020, Dec-01, Volume: 19, Issue:12

    Topics: Administration, Cutaneous; Adult; Aerosols; Aged; Betamethasone; Calcitriol; Diarrhea; Drug Combinat

2020
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
Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL.
    Journal of drugs in dermatology : JDD, 2018, Feb-01, Volume: 17, Issue:2

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Biological Factors; Diarrhea; Double-Blind Method; F

2018
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
Apremilast for discoid lupus erythematosus: results of a phase 2, open-label, single-arm, pilot study.
    Journal of drugs in dermatology : JDD, 2012, Volume: 11, Issue:10

    Topics: Adult; Aged; Diarrhea; Female; Headache; Humans; Intention to Treat Analysis; Lupus Erythematosus, D

2012
Thalidomide prolongs disease stabilization after conventional therapy in patients with recurrent glioblastoma.
    Oncology reports, 2004, Volume: 11, Issue:1

    Topics: Adult; Aged; Angiogenesis Inhibitors; Constipation; Disease Progression; Female; Glioblastoma; Heada

2004
A phase II, pharmacokinetic, and biologic study of semaxanib and thalidomide in patients with metastatic melanoma.
    Cancer chemotherapy and pharmacology, 2007, Volume: 59, Issue:2

    Topics: Adult; Aged; Angiogenesis Inhibitors; Area Under Curve; Asthenia; Dose-Response Relationship, Drug;

2007

Other Studies

8 other studies available for thalidomide and Bilateral Headache

ArticleYear
Multidisciplinary Management of the Adverse Effects of Apremilast.
    Actas dermo-sifiliograficas, 2021, Volume: 112, Issue:2

    Topics: Combined Modality Therapy; Diarrhea; Disease Management; Headache; Humans; Nausea; Patient Care Team

2021
Dementia and multiple myeloma.
    British journal of hospital medicine (London, England : 2005), 2017, Apr-02, Volume: 78, Issue:4

    Topics: Aged; Back Pain; Blood Viscosity; Dementia; Dexamethasone; Female; Glucocorticoids; Headache; Humans

2017
Apremilast in psoriasis - a prospective real-world study.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2018, Volume: 32, Issue:2

    Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthralgia; Body Weight; Diarrhea; Drug Substi

2018
Adverse events associated with apremilast use and withdrawal for psoriasis in a real-world setting.
    Journal of the European Academy of Dermatology and Venereology : JEADV, 2018, Volume: 32, Issue:10

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Diarrhea; Female; Headache; Humans; Male; Middle Age

2018
Long-term 52-week trends in apremilast safety outcomes for treatment of psoriasis in clinical practice: a multicentre, retrospective case series.
    The British journal of dermatology, 2019, Volume: 180, Issue:1

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Diarrhea; Female; Headache; Humans; Long-Term Care;

2019
Real-world use of apremilast for patients with psoriasis in Japan.
    The Journal of dermatology, 2018, Volume: 45, Issue:11

    Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Diarrhea; Female; Headache;

2018
Thalidomide-related headache.
    Dermatology (Basel, Switzerland), 2009, Volume: 218, Issue:3

    Topics: Adult; Dermatologic Agents; Female; Headache; Humans; Male; Middle Aged; Thalidomide

2009
[THALIDOMIDE POLYNEURITIS: A FORM OF RIBOFLAVIN AVITAMINOSIS?].
    Nordisk medicin, 1963, Aug-15, Volume: 70

    Topics: Avitaminosis; Dermatology; Drug Hypersensitivity; Edema; Folic Acid; Geriatrics; Headache; Neuritis;

1963