Effects of apremilast: A Synthesis of Findings from 16 Studies

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Original Abstract of the Article

Major Research Findings

Apremilast is a relatively new medication used to treat moderate to severe plaque psoriasis in adults. 14 Apremilast is considered safe with a very low risk of serious side effects, but some common side effects have been reported, including diarrhea, nausea, headache, and nasopharyngitis. 14 Apremilast is a selective inhibitor of phosphodiesterase-4 (PDE4), which is involved in various neurological diseases, including stroke. 4 Apremilast has been shown to have protective effects on stroke outcomes and blood-brain barrier (BBB) dysfunction in mice. 4 Apremilast has also been shown to have neuroprotective properties in astrocytes. 7 Apremilast can also affect the QTc interval on an electrocardiogram (ECG). 15

Benefits and Risks

Benefits Summary

Apremilast has been shown to be effective in treating inflammatory diseases such as psoriasis, psoriatic arthritis, and ulcerative colitis. 10 , 11 It has also been shown to have protective effects against stroke and ischemic brain injury. 4 , 7 Apremilast has been found to be effective in treating hypertrophic scars. 5

Risks Summary

Apremilast is generally considered safe, but it can cause side effects such as diarrhea, nausea, headache, and nasopharyngitis. 14 Apremilast may affect the QTc interval on an electrocardiogram (ECG). 15

Comparison of Studies

Commonalities of Studies

Multiple studies have shown that apremilast is effective in treating inflammatory diseases such as psoriasis, psoriatic arthritis, and ulcerative colitis. 10 , 11 Apremilast works by inhibiting PDE4, which is involved in regulating the inflammatory response. 13 Apremilast is generally safe, but can cause side effects, including diarrhea, nausea, headache, and nasopharyngitis. 14

Differences Between Studies

The effectiveness of apremilast can vary depending on the type and severity of the disease. 10 , 11 Side effects of apremilast can vary between individuals. 14

Consistency and Contradictions of Findings

Multiple studies have shown that apremilast is effective in treating inflammatory diseases such as psoriasis, psoriatic arthritis, and ulcerative colitis. 10 , 11 However, the effectiveness and side effects of apremilast may vary between individuals. 14 Further research is needed to clarify the long-term effectiveness and side effects of apremilast.

Practical Applications and Precautions

Apremilast has been shown to be effective in treating inflammatory diseases such as psoriasis, psoriatic arthritis, and ulcerative colitis. 10 , 11 However, apremilast can cause side effects, including diarrhea, nausea, headache, and nasopharyngitis. 14 If you are considering taking apremilast, consult with your doctor.

Limitations of Current Research

There is not enough research on apremilast yet. 10 , 11 Further research is needed to understand the long-term effectiveness and side effects of apremilast.

Future Research Directions

Further research is needed to understand the long-term effectiveness and side effects of apremilast. 10 , 11 Research is also needed to understand the effectiveness and safety of apremilast for other diseases.

Conclusion

Apremilast has been shown to be effective in treating inflammatory diseases such as psoriasis, psoriatic arthritis, and ulcerative colitis. 10 , 11 However, apremilast can cause side effects, including diarrhea, nausea, headache, and nasopharyngitis. 14 If you are considering taking apremilast, consult with your doctor.

Literature analysis of 16 papers
Positive Content
16
Neutral Content
0
Negative Content
0
Article Type
5
1
1
3
16
1.

Double-blind comparison of amoxapine and imipramine in the treatment of depressed patients.

Author: GelenbergA J, WojcikJ D, LydiardR B, McCormickM G, FalkW E, HicksR H, CurrenF C, CohenB M

Rapid action
Similar antidepressant efficacy
Anticholinergic effects
Sedation

Amoxapine was comparable to imipramine in efficacy and rapidity of action, but it was associated with significant neuroleptic activity and side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Systematic studies with amoxapine, a new antidepressant.

Author: BanT A, FujimoriM, PetrieW M, RaghebM, WilsonW H

No effect on psychomotor performance
Rapid onset of action

Amoxapine, an antidepressant, was found to be as effective when administered in a single daily dose as when administered in divided daily doses in 35 hospitalized patients with depressive disorders. The drug was well-tolerated and had minimal effects on psychomotor performance.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

3.

Therapeutic Effects of Apremilast on Enthesitis and Dactylitis in Real Clinical Setting: An Italian Multicenter Study.

Author: Lo GulloAlberto, BeccioliniAndrea, ParisiSimone, Del MedicoPatrizia, FarinaAntonella, VisalliElisa, Dal BoscoYlenia, Molica ColellaAldo Biagio, LumettiFederica, CaccavaleRosalba, ScolieriPalma, AndraccoRomina, GirelliFrancesco, BraviElena, ColinaMatteo, VolpeAlessandro, IannielloAurora, DittoMaria Chiara, NuceraValeria, FranchinaVeronica, PlatéIlaria, Di DonatoEleonora, AmatoGiorgio, SalvaraniCarlo, BernardiSimone, LucchiniGianluca, De LuciaFrancesco, Molica ColellaFrancesco, SantilliDaniele, MansuetoNatalia, FerreroGiulio, MarchettaAntonio, ArrigoniEugenio, FotiRosario, SandriGilda, BruzzeseVincenzo, ParoliMarino, FusaroEnrico, ArianiAlarico

Dactylitis improvement
Enthesitis improvement
Remission of dactylitis
Remission of enthesitis

Apremilast significantly improved enthesitis and dactylitis activity in patients with psoriatic arthritis (PsA), with more than one-third achieving remission after 1 year.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Apremilast exerts protective effects on stroke outcomes and blood-brain barrier (BBB) dysfunction through regulating Rho-associated protein kinase 2 expression.

Author: WangMingyuan, MengXiangyuan, ChengZhihua

Protective effects

The study investigated the effects of apremilast (APR), a selective inhibitor of phosphodiesterase-4, on stroke outcomes and blood-brain barrier (BBB) dysfunction in a middle cerebral artery occlusion (MCAO) stroke mice model.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

Beneficial effects of apremilast on genital ulcers, skin lesions, and arthritis in patients with Behçet's disease: A systematic review and meta-analysis.

Author: IizukaYuki, Takase-MinegishiKaoru, HiraharaLisa, KirinoYohei, SoejimaYutaro, NamkoongH O, HoritaNobuyuki, YoshimiRyusuke, TakeuchiMasaki, TakenoMitsuhiro, MizukiNobuhisa, NakajimaHideaki

Improved BD symptoms

Apremilast improved mucocutaneous and articular symptoms in patients with Behçet's disease (BD). After 12 weeks, patients showed significant improvement in oral ulcers, genital ulcers, erythema nodosum, pseudofolliculitis, and arthritis. The proportion of oral-ulcer-free patients increased at 24 weeks.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

7.

The Protective Effects of Apremilast Against Oxygen-Glucose Deprivation/Reperfusion (OGD/R)-Induced Inflammation and Apoptosis in Astroglia Mediated by CREB/BDNF.

Author: YinHang, QinHao, WangTiantian, ZhuangQiang, YangQixia

Astrocyte protection

This study investigated the effects of apremilast, a phosphodiesterase 4 (PDE4) inhibitor, on OGD/R-challenged astrocytes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Multidisciplinary Management of the Adverse Effects of Apremilast.

Author: Daudén TelloE, Alonso SuárezJ, Beltrán CatalánE, Blasco MaldonadoC, Herrero MansoM C, Jiménez MoralesA, Marín-JiménezI, Martín-ArranzM D, García-MerinoA, Porta EtessamJ, Rodríguez-SagradoM A, Rosas Gómez de SalazarJ, Trujillo MartínE, Salgado-BoqueteL

Apremilast management
Diarrhea
Headache
Nausea

The study proposes a series of general and specific recommendations for managing the most common adverse effects of apremilast that lead to treatment discontinuation: diarrhea, nausea, and headache. These recommendations are based on a review of the literature and the experience of a multidisciplinary team of experts.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Apremilast regulates acute effects of ethanol and other GABAergic drugs via protein kinase A-dependent signaling.

Author: BlednovYuri A, BorgheseCecilia M, DuganMichael P, PradhanSwetak, ThodatiThanvi M, KichiliNikhita R, HarrisR Adron, MessingRobert O

This study investigated the mechanisms by which apremilast, a phosphodiesterase 4 (PDE4) inhibitor, alters the effects of ethanol and GABAergic drugs in mice. Apremilast was found to prolong the sedative-hypnotic effects of some GABAergic drugs, while shortening the effects of others, suggesting complex interactions with GABA receptor subtypes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

10.

Large-scale Analyses of Disease Biomarkers and Apremilast Pharmacodynamic Effects.

Author: MedvedevaIrina V, StokesMatthew E, EisingerDominic, LaBrieSamuel T, AiJing, TrotterMatthew W B, SchaferPeter, YangRobert

Disease severity biomarker
Pharmacodynamic effects biomarker
Response status biomarker

This study presents the largest plasma proteomic biomarker dataset available from apremilast clinical trials in psoriasis, psoriatic arthritis, and ankylosing spondylitis. In psoriasis patients, IL-17A and KLK-7 were identified as biomarkers for disease severity and apremilast pharmacodynamic effect. Combined decline rate of KLK-7, PEDF, MDC, and ANGPTL4 was associated with responders. In ankylosing spondylitis, IL-6 and LRG-1 were identified as biomarkers for disease severity.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis.

Author: DaneseSilvio, NeurathMarkus F, KopońAdam, ZakkoSalam F, SimmonsTimothy C, FogelRonald, SiegelCorey A, PanaccioneRemo, ZhanXiaojiang, UsiskinKeith, ChitkaraDenesh

Improved clinical and endoscopic features
Reduced inflammation markers
Headache
Nausea

Apremilast (30 mg or 40 mg) was associated with improvements in clinical and endoscopic features, and markers of inflammation, in patients with active ulcerative colitis. Clinical remission was maintained to week 52 in up to 40% of patients who continued apremilast.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

[Gastrointestinal side effects of apremilast : Characterization and management].

Author: PinterAndreas, BeigelFlorian, KörberAndreas, HomeyBernhard, BeissertStefan, GerdesSascha, Staubach-RenzPetra, RadtkeMarc-Alexander, MössnerRotraut

Psoriasis treatment
Psoriatic arthritis treatment
Gastrointestinal side effects

Apremilast, a PDE4 inhibitor used for psoriasis and psoriatic arthritis, commonly causes diarrhea and nausea, typically during the first month of treatment. These side effects are usually mild or moderate and tend to resolve over time. This review provides information on gastrointestinal side effects of apremilast and strategies for management.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : German

13.

Mechanisms Underlying the Clinical Effects of Apremilast for Psoriasis.

Author: PincelliCarlo, SchaferPeter H, FrenchLars E, AugustinMatthias, KruegerJames G

Psoriasis Treatment
Psoriatic Arthritis Treatment

Psoriasis is a skin disease caused by an overactive immune system. This study looked at how a drug called apremilast, which targets a protein called PDE4 in the immune system, could help treat psoriasis. The study showed that apremilast reduced the levels of several inflammatory proteins in the blood and improved skin symptoms.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

Management of Common Side Effects of Apremilast.

Author: LangleyAnnie, BeeckerJennifer

psoriasis treatment
diarrhea
headache
nasopharyngitis
nausea

Apremilast is a medication used to treat moderate to severe plaque psoriasis. While generally safe, it can cause common side effects like diarrhea, nausea, headache, and nasopharyngitis. These side effects are often manageable with appropriate interventions, but they can lead to medication nonadherence if not addressed.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

The effects of apremilast on the QTc interval in healthy male volunteers: a formal, thorough QT study.

Author: PalmisanoMaria, WuAnfan, AssafMahmoud, LiuLiangang, ParkC Hyung, SavantIshani, LiuYong, ZhouSimon

Apremilast safe
Apremilast well-tolerated

Apremilast did not prolong the QT interval and appears to be safe and well tolerated up to doses of 50 mg twice daily.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

16.

Apremilast, an oral phosphodiesterase-4 inhibitor, in the treatment of palmoplantar psoriasis: Results of a pooled analysis from phase II PSOR-005 and phase III Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) clinical trials in patients with moderate to severe psoriasis.

Author: BissonnetteRobert, PariserDavid M, WaselNorman R, GoncalvesJoana, DayRobert M, ChenRongdean, SebastianMichael

Useful treatment option

Apremilast may be a useful oral treatment option for patients with moderate to severe palmoplantar plaque psoriasis. Significantly more patients taking apremilast with moderate to severe palmoplantar psoriasis achieved PPPGA score 0 (clear) or 1 (almost clear) compared with placebo at week 16.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

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