scholarly journals Topical Application of Apremilast in the Treatment of Mild to Moderate Psoriasis

2021 ◽  
Vol 2 (1) ◽  
pp. 01-10
Author(s):  
Srikanth Kalakoti
Keyword(s):  
Side Effects ◽  
Treatment Options ◽  
Unmet Need ◽  
Autoimmune Disorder ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Average Percentage ◽  
Topical Dosage ◽  
Topical Gels

Background: Psoriasis is a chronic, autoimmune disorder that affects the skin and joints with an approximate global prevalence of 2–3%. Mild to moderate psoriasis is highly prevalent in about 80% of the global psoriatic population (2-3%). Currently available treatment options for mild to moderate psoriasis are topical dosage forms. Though a variety of topical formulations available, they are associated with different side effects. There is an unmet need for a product that can be used for a prolonged period with minimal side effects. Hence, Apremilast gel was developed and clinical proof of concept study (POC) was performed to investigate the efficacy and safety in mild to moderate psoriasis patients. Methods: A single-center randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of apremilast topical gels 2% & 4% w/w, in adult mild to moderate psoriatic patients for 12 weeks. Patients were examined at weeks 0, 2, 4, 8, and 12 weeks to assess the efficacy and safety. At 0 and 8 weeks, blood samples were collected to investigate the pharmacokinetics. The significance in % recovery was calculated statistically. Results: Both gels exhibited a significant reduction in PASI values when compared with baseline PASI scores. The average percentage inhibition of PASI with test products i.e. 2% and 4% w/w Apremilast topical gels is about 46.8% and 34.6% respectively after 12 weeks of treatment. Both the test products have not shown any adverse effects, hematological & biochemical changes and have exhibited Cmax less than 20ng/ml after 6 hours of application. Conclusion: Results have shown that topically applied apremilast could be an effective and safe option for the management of mild to moderate psoriasis.

Topical application of Apremilast in the treatment of mild to moderate psoriasis

2021 ◽  
Vol 9 (1) ◽  
pp. 12-16
Author(s):  
Srikanth Kalakoti ◽  
Narasimharao Netha G
Keyword(s):  
Treatment Options ◽  
Controlled Study ◽  
Proof Of Concept ◽  
Double Blind ◽  
Average Percentage ◽  
Before And After ◽  
Topical Dosage ◽  
Associated Variety ◽  
Topical Dosage Forms ◽  
Topical Gels

Mild to moderate psoriasis is highly prevalent in about 80% of the global psoriatic population. Current available treatment options for mild to moderate psoriasis are topical dosage forms and are associated variety of setbacks. To address these setbacks, Apremilast topical gels, 2% & 4%, w/w were developed, and a clinical proof of concept study (POC) was performed to establish efficacy and safety. A single centre randomized, double-blind, placebo-controlled study was conducted with apremilast topical gels 2% & 4% w/w in adult mild to moderate psoriatic patients for 12 weeks. The efficacy of the gels was evaluated by comparing the PASI scores before and after treatment of 12 weeks. Both gels exhibited a significant reduction in PASI values when compared with baseline PASI scores. An average percentage inhibition of PASI with test products, i.e. 2% and 4% w/w Apremilast topical gels, are about 46.8% and 34.6%, respectively, after 12 weeks of treatment. The results confirm that the apremilast topical gels are a good option for the treatment of mild to moderate psoriasis and have to be explored further. 

scholarly journals Efficacy and Safety of Tradipitant in Diabetic and Idiopathic Gastroparesis: A Randomized, Placebo-Controlled Study

2020 ◽  
Author(s):  
Jesse L. Carlin ◽  
V. Rose Lieberman ◽  
Arya Dahal ◽  
Madison S. Keefe ◽  
Changfu Xiao ◽  
...  
Keyword(s):  
Unmet Need ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Symptom Index ◽  
Idiopathic Gastroparesis ◽  
Patient Reported ◽  
Cardinal Symptom ◽  
To Receive

AbstractBackground and AimsThere is a high unmet need for the treatment of gastroparesis and studies of NK1-R antagonists suggest potential benefit in reducing the symptoms of nausea and vomiting. We hypothesized that tradipitant, an NK1-R antagonist, would be effective in treating patients with idiopathic or diabetic gastroparesis.MethodsIn a randomized, double-blind, placebo-controlled study across 47 U.S. sites, 152 gastroparesis patients were randomized to receive oral 85mg BID tradipitant (n=77) or placebo (n=75) daily for four weeks. Symptoms were assessed using a daily symptom dairy, Gastroparesis Cardinal Symptom Index (GCSI), and other patient reported questionnaires.ResultsPatients receiving tradipitant had a significant decrease in nausea score at Week 4 compared to placebo (−1.2 improvement vs −0.7, respectively, p=0.0099), and a significant increase in nausea-free days (28.8% increase on tradipitant vs 15.0% on placebo p=0.0160). Patients with both nausea and vomiting at baseline (n=101) showed an even greater decrease in nausea score (−1.4 improvement on tradipitant vs −0.4 on placebo p<0.0001) and an increase in nausea free days (32.3% improvement on tradipitant vs 7.6% on placebo p=0.0003). 32.9% of patients treated with tradipitant were nausea responders (average nausea score ≤ 1 at week 4) compared to 11.8% of patients on placebo (p=0.0013). 46.6% of patients treated with tradipitant had a greater than 1-point improvement in GCSI score compared to 23.5% of patients on placebo (p=0.0053).ConclusionsTradipitant treatment resulted in statistically and clinically meaningful improvements in nausea and overall gastroparesis symptoms. These robust efficacy results suggest tradipitant has the potential to become a useful pharmacological treatment for gastroparesis.

485 Efficacy and Safety of Once- and Twice-Nightly Dosing of Lower-Sodium Oxybate in Adults With Idiopathic Hypersomnia

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A191-A192
Author(s):  
Isabelle Arnulf ◽  
Anne Marie Morse ◽  
Patricia Chandler ◽  
Rupa Parvataneni ◽  
Dan Chen ◽  
...  
Keyword(s):  
Sodium Oxybate ◽  
Mean Difference ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Patient Global Impression ◽  
Idiopathic Hypersomnia ◽  
Secondary Endpoints ◽  
Global Impression Of Change

Abstract Introduction Idiopathic hypersomnia (IH) is a rare central hypersomnolence disorder. In a randomized, controlled study of lower-sodium oxybate (LXB; Xywav™) in adults with IH (NCT03533114), significant differences for LXB compared with placebo were observed in Epworth Sleepiness Scale (ESS; primary efficacy endpoint), self-reported Patient Global Impression of Change (PGIc), and IH Severity Scale (IHSS; key secondary endpoints). In this clinical study, investigators were permitted to initiate LXB dosing on a once-nightly or twice-nightly regimen. Methods Eligible participants aged 18–75 years began LXB treatment, administered once or twice nightly during an open-label treatment/titration and optimization period (OLTTOP; 10–14 weeks); dose amount/regimen could be adjusted during this period. Participants next entered a 2-week, open-label, stable-dose period (SDP), then were randomized to placebo or to continue LXB treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). P values are nominal for this exploratory analysis. Results Of 154 enrolled participants, 40 (26%) initiated LXB treatment on a once-nightly regimen. In the efficacy population (n=115), 27 participants were on a once-nightly regimen during SDP (48.1% of whom initiated treatment once nightly during OLTTOP) and 88 participants were on a twice-nightly regimen during SDP (86.4% of whom initiated treatment twice nightly during OLTTOP). During SDP, median (min, max) LXB total dose was 4.5 (2.5, 6) g/night (once-nightly group) and 7.5 (4.5, 9) g/night (twice-nightly group). ESS scores worsened in participants randomized to placebo vs those continuing LXB in the once-nightly group (n=11 and n=15, respectively; LS mean difference [95% CI]: −4.93 [−7.41, −2.46]; P=0.0004) and twice-nightly group (n=47 and n=41, respectively; LS mean difference [95% CI]: −7.44 [−9.15, −5.72]; P&lt;0.0001). Worsening was also observed in PGIc (once-nightly: 81.8% [placebo] vs 26.7% [LXB]; P=0.0077; twice-nightly: 89.4% [placebo] vs 19.5% [LXB]; P&lt;0.0001) and IHSS score (estimated median difference [95% CI], once-nightly: −9.00 [−16.0, −3.0]; P=0.0028; twice-nightly: −12.00 [−15.0, −8.0]; P&lt;0.0001). Common adverse events included nausea (21.4%), headache (16.2%), anxiety (14.9%), dizziness (11.7%), insomnia (11.7%), and vomiting (10.4%). Conclusion The efficacy and safety of LXB in IH were demonstrated for both once-nightly and twice-nightly regimens. The majority of participants initiated and remained on a twice-nightly regimen. Support (if any) Jazz Pharmaceuticals

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