A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis

Pinter, Andreas; Green, L.J.; Selmer, Johan; Præstegaard, Morten; Gold, Linda Stein; Augustin, Matthias

doi:10.1111/jdv.17734

Cited by 28 publications

(72 citation statements)

References 21 publications

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“…Search results and study characteristics 18 articles reporting the results of 24 RCTs including 9748 patients with plaque psoriasis met the inclusion criteria. [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35] (Figure 1). Due to insufficient data,so we excluded tazarotene data from one of the articles.…”

Section: Resultsmentioning

confidence: 99%

Short-term topical therapies in treating plaque psoriasis: An updated systematic review and network meta-analysis

Wu¹,

gao²,

xiong³

et al. 2022

Preprint

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Objective:To perform a network meta-analysis(NMA) of randomized controlled trials of topical therapies for plaque psoriasis, especially some new drugs for psoriasis.Our objective was to establish the effectiveness, tolerability and safety of topical treatments for people with chronic plaque psoriasis. Methods: We systematically searched PubMed, Cochrane Library and Embase databases to identify randomized controlled trials of topical therapies in adult patients with plaque psoriasis.Due to older literature were not able to included some novel topical therapies,we only searched the article that published between 01 January 2010 and 20 February 2022 in English. The primary efficacy assessment criteria were treatment success(the number of patients who achieved Physician’s Global Assessment or Investigator’s Global Assessment of a score of clear or nearly clear(PGA0/1,IGA0/1)) and the paitents who reported adverse events (AEs) at 4-12 weeks. Secondary criteria were the propotion of patients with 75 % reductions in Psoriasis Area and Severity Index (PASI 75) and the number of patients who reported drug withdrawal due to adverse events at 4-12 weeks.We combined with hierarchical cluster analyses to consider efficacy, safety and tolerability. Results: The review included 24 randomized controlled trials of topical treatments for plaque psoriasis with 9748 participants. This network meta-analysis showed that topical treatments were significantly more effective than placebo at 4-12weeks, in addition to tofacitinib ointment. hierarchical cluster analyses shows that topical calcipotriene and betamethasone dipropionate(Cal/BD),roflumilast,betamethasone,halobetasol-propionate and tazarotene(HP/TAZ), halobetasol were comparable with respect to high short-term efficacy, safety and tolerability, especially Cal/BD and roflumilast.

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Section: Resultsmentioning

confidence: 99%

Short-term topical therapies in treating plaque psoriasis: An updated systematic review and network meta-analysis

Wu¹,

gao²,

xiong³

et al. 2022

Preprint

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“…The pooled phase 3 data demonstrate that a significantly greater proportion of patients achieved treatment success in the physician global assessment (PGA), defined as a minimum improvement of two grades to “clear” or “almost clear” disease. After 8 weeks of treatment, 43.2% of patients in the CAL/BDP PAD-cream group achieved PGA treatment success, compared to 31.9% in the CAL/BDP topical suspension/gel group ( p < 0.0001) and 5.2% in the vehicle cream group ( p < 0.0001) [ 31 ]. In one of the phase 3 trials, patients with body and scalp psoriasis were enrolled.…”

Section: Topical Delivery Of Active Compoundsmentioning

confidence: 99%

“…The trial protocol was approved by institutional review boards for each site, and all patients provided written informed consent prior to any trial-related procedures. Detailed efficacy data from phase 3 trials are presented elsewhere [ 31 , 63 ] …”

Section: Topical Delivery Of Active Compoundsmentioning

confidence: 99%

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Polyaphron Dispersion Technology, A Novel Topical Formulation and Delivery System Combining Drug Penetration, Local Tolerability and Convenience of Application

Præstegaard

Steele²,

Crutchley

2022

Dermatol Ther (Heidelb)

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Topical formulation and delivery technologies for pharmaceutical application should simultaneously address efficacy, safety and convenience of therapy. This has historically proven to be challenging, since formulation features that drive efficacy often have undesirable consequences for safety and convenience and vice versa. Polyaphron dispersion (PAD) technology is a novel topical formulation and drug delivery system developed with the purpose of preserving these key attributes. PAD formulations are typically oil-in-water dispersions consisting of oil droplets encapsulated in a multi-molecular shell structure. This shell structure protects potentially unstable active molecules solubilized in the oil from hydrolytic degradation. Example data are presented of enhanced drug penetration from PAD formulations, including dermal delivery of calcipotriene, betamethasone dipropionate and tacrolimus as well as ocular delivery of ciclosporin A. Local tolerability is an important safety parameter for topical formulations, where high levels of surfactants can cause skin irritation. In this regard, a key benefit of PAD formulations is the inherent reduced requirement for surfactants to generate stable formulations compared to conventional emulsion systems. Patients with chronic diseases with topical manifestations such as psoriasis or atopic dermatitis have been reported to miss up to 70% of planned topical applications, mainly due to a lack of satisfaction with their therapy. Patients generally prefer light, moisturizing, non-greasy and quickly absorbed vehicles that are simple to use on all body parts. PAD formulations can generally be designed to meet these criteria. In conclusion, PAD technology provides high flexibility in topical drug design and can be applied to several body locations without compromising efficacy, safety or convenience of therapy. Clinical Trial Register : Clinicaltrials.gov: NCT03802344.

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“…Similarly, calcipotriene (0.005% and betamethasone dipropionate 0.064%) ointment improved the presentation of psoriasis [ 267 ]. Pinter et al data showed the high effectiveness of calcipotriene and betamethasone PAD TM Technology cream with no adverse drug reaction in two Pahase 3, multicenter, randomized, investigator-blind studies [ 268 ]. Different clinical studies report that the combination of calcipotriene and betamethasone dipropionate in foam solution to be the most effective treatment for mild psoriasis [ 269 ].…”

Section: Vitamin D Paradigm In the Psoriasis Treatmentmentioning

confidence: 99%

Vitamin D Signaling in Psoriasis: Pathogenesis and Therapy

Brożyna

Slominski

Nedoszytko

et al. 2022

IJMS

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Psoriasis is a systemic, chronic, immune-mediated disease that affects approximately 2–3% of the world’s population. The etiology and pathophysiology of psoriasis are still unknown, but the activation of the adaptive immune system with the main role of T-cells is key in psoriasis pathogenesis. The modulation of the local neuroendocrine system with the downregulation of pro-inflammatory and the upregulation of anti-inflammatory messengers represent a promising adjuvant treatment in psoriasis therapies. Vitamin D receptors and vitamin D-mediated signaling pathways function in the skin and are essential in maintaining the skin homeostasis. The active forms of vitamin D act as powerful immunomodulators of clinical response in psoriatic patients and represent the effective and safe adjuvant treatments for psoriasis, even when high doses of vitamin D are administered. The phototherapy of psoriasis, especially UVB-based, changes the serum level of 25(OH)D, but the correlation of 25(OH)D changes and psoriasis improvement need more clinical trials, since contradictory data have been published. Vitamin D derivatives can improve the efficacy of psoriasis phototherapy without inducing adverse side effects. The anti-psoriatic treatment could include non-calcemic CYP11A1-derived vitamin D hydroxyderivatives that would act on the VDR or as inverse agonists on RORs or activate alternative nuclear receptors including AhR and LXRs. In conclusion, vitamin D signaling can play an important role in the natural history of psoriasis. Selective targeting of proper nuclear receptors could represent potential treatment options in psoriasis.

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A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis

Cited by 28 publications

References 21 publications

Short-term topical therapies in treating plaque psoriasis: An updated systematic review and network meta-analysis

Short-term topical therapies in treating plaque psoriasis: An updated systematic review and network meta-analysis

Polyaphron Dispersion Technology, A Novel Topical Formulation and Delivery System Combining Drug Penetration, Local Tolerability and Convenience of Application

Vitamin D Signaling in Psoriasis: Pathogenesis and Therapy

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