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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.
Excerpt | Relevance | Reference |
---|---|---|
"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." | 9.34 | Apremilast 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." | 9.24 | 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) |
"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." | 9.12 | A 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." | 8.93 | Apremilast: 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." | 7.88 | Apremilast 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." | 7.88 | Real-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." | 6.87 | Efficacy 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." | 6.71 | Thalidomide 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." | 5.34 | Apremilast 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." | 5.24 | 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) |
"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." | 5.12 | A 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." | 4.93 | Apremilast: 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." | 4.02 | Multidisciplinary 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." | 3.88 | Apremilast 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." | 3.88 | Real-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." | 2.87 | Efficacy 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." | 2.77 | Apremilast 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." | 2.71 | Thalidomide prolongs disease stabilization after conventional therapy in patients with recurrent glioblastoma. ( Carillio, G; Fanelli, M; Gasparini, G; Gattuso, D; Morabito, A; Sarmiento, R, 2004) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 1 (6.25) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 3 (18.75) | 29.6817 |
2010's | 10 (62.50) | 24.3611 |
2020's | 2 (12.50) | 2.80 |
Authors | Studies |
---|---|
Daudén Tello, E | 1 |
Alonso Suárez, J | 1 |
Beltrán Catalán, E | 1 |
Blasco Maldonado, C | 1 |
Herrero Manso, MC | 1 |
Jiménez Morales, A | 1 |
Marín-Jiménez, I | 1 |
Martín-Arranz, MD | 1 |
García-Merino, A | 1 |
Porta Etessam, J | 1 |
Rodríguez-Sagrado, MA | 1 |
Rosas Gómez de Salazar, J | 1 |
Trujillo Martín, E | 1 |
Salgado-Boquete, L | 1 |
Bagel, J | 2 |
Nelson, E | 1 |
Riley, C | 1 |
Hetzel, A | 1 |
Jolobe, OM | 1 |
Crowley, J | 1 |
Thaçi, D | 1 |
Joly, P | 1 |
Peris, K | 1 |
Papp, KA | 1 |
Goncalves, J | 3 |
Day, RM | 2 |
Chen, R | 2 |
Shah, K | 2 |
Ferrándiz, C | 1 |
Cather, JC | 1 |
Vujic, I | 1 |
Herman, R | 1 |
Sanlorenzo, M | 1 |
Posch, C | 1 |
Monshi, B | 1 |
Rappersberger, K | 1 |
Richter, L | 1 |
Stein Gold, L | 1 |
Lebwohl, M | 1 |
Jackson, JM | 1 |
Levi, E | 1 |
Duffin, KC | 1 |
Lee, EB | 1 |
Amin, M | 1 |
Egeberg, A | 1 |
Wu, JJ | 1 |
Ighani, A | 1 |
Georgakopoulos, JR | 1 |
Shear, NH | 1 |
Walsh, S | 1 |
Yeung, J | 1 |
Kishimoto, M | 1 |
Komine, M | 1 |
Hioki, T | 1 |
Kamiya, K | 1 |
Sugai, J | 1 |
Ohtsuki, M | 1 |
Haber, SL | 1 |
Hamilton, S | 1 |
Bank, M | 1 |
Leong, SY | 1 |
Pierce, E | 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 |
Phan, A | 1 |
Favrole, P | 1 |
Alamowitch, S | 1 |
Chosidow, O | 1 |
De Souza, A | 1 |
Strober, BE | 1 |
Merola, JF | 1 |
Oliver, S | 1 |
Franks, AG | 1 |
SKRE, H | 1 |
Morabito, A | 1 |
Fanelli, M | 1 |
Carillio, G | 1 |
Gattuso, D | 1 |
Sarmiento, R | 1 |
Gasparini, G | 1 |
Mita, MM | 1 |
Rowinsky, EK | 1 |
Forero, L | 1 |
Eckhart, SG | 1 |
Izbicka, E | 1 |
Weiss, GR | 1 |
Beeram, M | 1 |
Mita, AC | 1 |
de Bono, JS | 1 |
Tolcher, AW | 1 |
Hammond, LA | 1 |
Simmons, P | 1 |
Berg, K | 1 |
Takimoto, C | 1 |
Patnaik, A | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
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 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 4 | 221 participants (Actual) | Interventional | 2015-04-20 | 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] |
"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)
Intervention | units on a scale (Mean) |
---|---|
Placebo | -2.4 |
Apremilast | -4.8 |
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)
Intervention | percentage change (Mean) |
---|---|
Placebo | -3.87 |
Apremilast | -40.72 |
"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)
Intervention | percentage change (Mean) |
---|---|
Placebo | -10.17 |
Apremilast | -48.07 |
"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
Intervention | percentage change (Mean) |
---|---|
Placebo-Apremilast | -42.23 |
Apremilast | -55.45 |
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)
Intervention | percentage of participants (Number) |
---|---|
Placebo | 20.5 |
Apremilast | 33.8 |
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)
Intervention | percentage of participants (Number) |
---|---|
Placebo | 9.6 |
Apremilast | 30.4 |
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)
Intervention | percentage of participants (Number) |
---|---|
Placebo | 24.7 |
Apremilast | 53.4 |
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)
Intervention | percentage of participants (Number) |
---|---|
Placebo | 8.2 |
Apremilast | 21.6 |
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)
Intervention | percentage of participants (Number) |
---|---|
Placebo | 38.2 |
Apremilast | 50.0 |
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)
Intervention | units on a scale (Mean) | |
---|---|---|
Week 1 | Week 16 | |
Apremilast | -13.9 | -19.2 |
Placebo | -9.6 | -10.2 |
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
Intervention | participants (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 interruption | Any TEAE leading to death | |
Apremilast | 142 | 98 | 5 | 10 | 1 | 14 | 27 | 0 |
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
Intervention | participants (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 interruption | Any TEAE leading to death | |
Apremilast | 92 | 71 | 3 | 3 | 0 | 5 | 9 | 0 |
Placebo | 35 | 21 | 1 | 0 | 0 | 3 | 3 | 0 |
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
Intervention | percentage of participants (Number) | |
---|---|---|
Responder status at Week 16 | Responder status maintained at Week 52 | |
Apremilast | 50.0 | 80.4 |
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)
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
TSQM-Effectiveness | TSQM-Side Effects | TSQM-Convenience | TSQM-Global Satisfaction | |
Apremilast | 57.25 | 78.50 | 66.93 | 63.24 |
Placebo | 38.81 | 75.00 | 65.68 | 48.74 |
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
Intervention | units on a scale (Mean) | |||
---|---|---|---|---|
TSQM-Effectiveness | TSQM-Side Effects | TSQM-Convenience | TSQM-Global Satisfaction | |
Apremilast | 54.13 | 75.45 | 71.76 | 59.92 |
Placebo-Apremilast | 57.68 | 77.29 | 72.74 | 59.24 |
"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 |
1 review available for thalidomide and Bilateral Headache
Article | Year |
---|---|
Apremilast: A Novel Drug for Treatment of Psoriasis and Psoriatic Arthritis.
Topics: Antirheumatic Agents; Arthritis, Psoriatic; Diarrhea; Headache; Humans; Nausea; Psoriasis; Thalidomi | 2016 |
7 trials available for thalidomide and Bilateral Headache
Article | Year |
---|---|
Apremilast with Add-On Calcipotriene/Betamethasone Dipropionate for Treating Moderate to Severe Plaque Psoriasis.
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).
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 |
Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL.
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).
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.
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.
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.
Topics: Adult; Aged; Angiogenesis Inhibitors; Area Under Curve; Asthenia; Dose-Response Relationship, Drug; | 2007 |
8 other studies available for thalidomide and Bilateral Headache
Article | Year |
---|---|
Multidisciplinary Management of the Adverse Effects of Apremilast.
Topics: Combined Modality Therapy; Diarrhea; Disease Management; Headache; Humans; Nausea; Patient Care Team | 2021 |
Dementia and multiple myeloma.
Topics: Aged; Back Pain; Blood Viscosity; Dementia; Dexamethasone; Female; Glucocorticoids; Headache; Humans | 2017 |
Apremilast in psoriasis - a prospective real-world study.
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.
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.
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.
Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Diarrhea; Female; Headache; | 2018 |
Thalidomide-related headache.
Topics: Adult; Dermatologic Agents; Female; Headache; Humans; Male; Middle Aged; Thalidomide | 2009 |
[THALIDOMIDE POLYNEURITIS: A FORM OF RIBOFLAVIN AVITAMINOSIS?].
Topics: Avitaminosis; Dermatology; Drug Hypersensitivity; Edema; Folic Acid; Geriatrics; Headache; Neuritis; | 1963 |