Rapid Onset of Action and Quality-of-Life Improvements in Chinese Patients with Plaque Psoriasis Treated with Calcipotriol plus Betamethasone Dipropionate Aerosol Foam in a Randomized Phase 3 Trial

Abstract

Introduction

The aerosol foam formulation of calcipotriol/betamethasone dipropionate (Cal/BD) is an efficacious topical treatment for psoriasis. This study evaluated the efficacy of Cal/BD foam versus ointment in Chinese patients, on the basis of investigator-assessed and patient-reported outcomes (PROs) from a 4-week clinical trial, including post hoc analyses after 2 weeks of treatment.

Methods

A randomized, investigator-blind, active-controlled, parallel-group phase 3 trial was conducted in China. Native Chinese adults (≥ 18 years) with plaque psoriasis involving 2–30% of the body surface area (BSA), with at least mild disease severity according to the Physician’s Global Assessment (PGA), and modified Psoriasis Area and Severity Index (mPASI) ≥ 2 were randomized 1:1 to receive either Cal/BD foam or ointment once daily for a 4-week treatment period. Efficacy was assessed at weeks 0, 2, and 4 using mPASI, PGA, BSA, Dermatology Life Quality Index (DLQI), Psoriasis Symptom Inventory (PSI), and Subject’s Global Assessment of disease severity (SGA).

Results

A total of 302 patients were randomized to each treatment. Both groups had clinically meaningful improvements across all outcome measures from baseline to week 2, with sustained or further improvements at week 4. For Cal/BD foam-treated patients, mean change from baseline in mPASI was −59.87% at week 2 (versus ointment: −54.59%; P = 0.010) and −74.69% at week 4 (versus ointment: −70.22%; P = 0.043). Other investigator-assessed outcomes based on mPASI and PGA showed statistically significant treatment differences favoring Cal/BD foam at week 4. Improvements in PROs (DLQI, PSI, and SGA) were numerically slightly greater with Cal/BD foam than ointment, though not statistically significant. For Cal/BD foam-treated patients, mean change from baseline in DLQI was −3.9 at week 2 (versus ointment: −3.7; P = 0.5012) and −5.5 at week 4 (versus ointment: −5.3; P = 0.5119).

Conclusions

Cal/BD foam showed rapid onset of action with clinically meaningful improvements in signs, symptoms, and quality of life in Chinese patients with plaque psoriasis.

Trial Registration

ClinicalTrials.gov: NCT05919082.

Graphical Abstract

Plain Language Summary

Plaque psoriasis is the most common type of psoriasis, a chronic disease affecting the skin and other body systems. Plaques are thick, scaly patches of skin that can be itchy and painful, limiting patients’ everyday activities. Plaque psoriasis has a major impact on quality of life, comparable with the impact of other chronic diseases such as cancer and heart disease. Many treatments, such as creams, tablets, and injections, can improve plaque psoriasis, but they do not always work well for everyone. In a clinical trial in China, we tested two treatments—a foam and an ointment—that have the same amount of two active ingredients: calcipotriol (Cal) and betamethasone dipropionate (BD). The goal was to find out if Cal/BD foam, which is the newer treatment, worked as well as Cal/BD ointment in Chinese men and women with plaque psoriasis. The trial participants were randomly distributed into two groups, each with 302 participants. One group applied Cal/BD foam on their plaques and the other group applied Cal/BD ointment, both once daily for 4 weeks. Both groups had meaningful improvements in psoriasis signs and symptoms as well as quality of life already after 2 weeks, with sustained or further improvements after 4 weeks. Overall, the improvements were slightly greater with Cal/BD foam than with Cal/BD ointment.

Supplementary Information

The online version contains supplementary material available at 10.1007/s13555-026-01763-5.

Key Summary Points

Why carry out this study?

Plaque psoriasis is a serious, chronic disease with major impact on patient quality of life and increasing global prevalence. In China, there is still a need for improved topical therapies for both short- and long-term treatment of patients with plaque psoriasis.

We hypothesized that the innovative aerosol foam formulation of 50 µg/g calcipotriol (Cal) and 0.5 mg/g betamethasone dipropionate (BD) would be at least as efficacious in Chinese patients as Cal/BD ointment, a standard-of-care treatment for plaque psoriasis in China.

What was learned from this study?

Efficacy outcomes for Cal/BD foam were on par with or better than those obtained with Cal/BD ointment in Chinese patients with plaque psoriasis.

Cal/BD foam showed rapid onset of action with clinically meaningful improvements in signs, symptoms, and quality of life. Such outcomes are likely to encourage treatment adherence, which is crucial for the initial control of signs and symptoms of psoriasis as well as its long-term management.

Digital Features

This article is published with digital features, including a graphical abstract, to facilitate understanding of the article. To view digital features for this article, go to 10.6084/m9.figshare.31963653.

Introduction

Psoriasis is an immune-mediated, chronic, and debilitating disease that affects not only the skin but also other body systems. Characterized by itchy, painful skin lesions and associated with multiple comorbidities, psoriasis harms physical as well as psychosocial well-being and impairs the ability to function in daily life [1]. The impact on health-related quality of life (HRQoL) for patients with psoriasis is comparable with that seen in other chronic diseases such as cancer and cardiovascular diseases [2]. Moreover, the global prevalence and burden of psoriasis are increasing [3, 4], despite continuous efforts to improve the management and treatment of this serious noncommunicable disease.

In the most common subtype, plaque psoriasis, ~ 80% of patients have mild-to-moderate disease that is amenable to treatment with topical agents [5]. In moderate-to-severe plaque psoriasis, topicals are often combined with phototherapy or systemic or biologic agents [6, 7].

The clinical benefit of any psoriasis therapy, however, hinges on patient adherence, which is typically low with topicals [8]. Given the intense burden of psoriasis and its impact on HRQoL, adherence is likely to improve if patients experience rapid relief of symptoms, with positive outcomes sustained over time [9].

Rapid onset of action as well as improved HRQoL have been shown in randomized clinical trials (RCTs) with the innovative aerosol foam formulation of 50 µg/g calcipotriol (Cal) and 0.5 mg/g betamethasone dipropionate (BD) [9–11]. This fixed-dose combination product, Cal/BD foam, has become a gold standard for topical treatment of plaque psoriasis in many countries [12, 13].

On the basis of the data from RCTs conducted in the USA and Europe, we hypothesized that the efficacy of Cal/BD foam in Chinese patients would be at least on par with that of Cal/BD ointment. The latter is a standard-of-care treatment for plaque psoriasis in China, where a need still exists for improved topical therapies for both short- and long-term treatment of patients with plaque psoriasis.

In the first RCT conducted with Cal/BD foam in China, using Cal/BD ointment as active comparator, the superior efficacy of the foam over the ointment was confirmed in native Chinese patients, as measured by investigator-assessed endpoints after 4 weeks of treatment. The safety profile of Cal/BD foam was similar to that of Cal/BD ointment, with a majority of adverse events (AEs) being mild and not treatment-related; no new safety concerns were identified [14]. This is consistent with findings in previous RCTs with Cal/BD foam [15–18] and the Cal/BD foam prescribing information.

Here, we present the exploratory patient-reported outcomes (PROs) from this Chinese RCT, along with post hoc analyses of investigator-assessed outcome measures as well as PROs after 2 weeks of treatment. Furthermore, we present the results of exploratory subgroup analyses based on baseline disease severity.

Methods

Clinical Trial Design and Participants

The trial was a randomized, investigator-blind, active-controlled, parallel-group, multi-center phase 3 trial in which Chinese adults with plaque psoriasis were treated with Cal/BD foam or Cal/BD ointment once daily for 4 weeks. The trial was preregistered at ClinicalTrials.gov on 16 June 2023 (https://clinicaltrials.gov/study/NCT05919082).

Patients were enrolled across 39 medical research centers and hospitals in China. At each investigational site, an independent ethics committee reviewed and approved the clinical trial protocol and informed consent form. The Ethical Review Committee of Peking University People’s Hospital provided the principal approval; the names of the remaining ethics committees are provided in Supplementary Table S1. The trial was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice, with the patients’ understanding and written informed consent. There was no patient or public involvement in the design, conduct, or reporting of the trial.

All patients had to be native Chinese aged ≥ 18 years, with a clinical diagnosis of stable plaque psoriasis. At baseline, the psoriasis had to be present on the trunk, limbs, or both (excluding the face, scalp, genitals, and skin folds, which were not treated in this trial), affect 2–30% of the body surface area, be at least mild according to the Physician’s Global Assessment of disease severity (PGA), and have a score of ≥ 2 on the Psoriasis Area and Severity Index [19], modified to exclude assessment of the face, scalp, genitals, and skin folds (modified Psoriasis Area and Severity Index [mPASI]). All inclusion and exclusion criteria are described in a previous publication [14].

Procedures, Assessments, and Endpoints

Patients were randomly assigned 1:1 to Cal/BD foam or Cal/BD ointment and instructed to apply the treatment once daily for 4 weeks to psoriasis plaques on the trunk, arms, and legs. Details regarding the randomization, blinding, and administration of trial drugs are described in the primary publication [14].

Efficacy was assessed at weeks 0 (baseline), 2, and 4. Investigators assessed the severity of psoriasis using the 5-point PGA scale (0: clear, 1: almost clear, 2: mild, 3: moderate, 4: severe) [20] and the extent and severity of clinical signs of psoriasis using the mPASI. Investigators also assessed the total psoriatic involvement on the trunk (including neck) and limbs (arms, including hands; legs, including feet and buttocks) as a percentage of the total BSA.

PROs included the Dermatology Life Quality Index (DLQI), a 10-item questionnaire asking patients to score the impact of their skin disease on different aspects of HRQoL using a 4-point scale, with total scores ranging from 0–1 (“no effect at all”) to 21–30 (“extremely large effect”) [21]; the Psoriasis Symptom Inventory (PSI), an 8-item questionnaire asking patients to rate the severity of their psoriasis symptoms over the last 7 days on a 5-point scale (from “not at all” to “very severe”), with total scores ranging from 0 to 32 [22]; and the Subject’s Global Assessment (SGA) of disease severity, a 5-point scale (from “clear” to “severe”) based on the degree of symptoms (see Supplementary Table S2 in the Electronic Supplementary Material).

The primary endpoint was “PGA score of 0 or 1 (PGA 0/1)” at week 4 (day 29) with ≥ 2-point reduction from baseline. Secondary efficacy endpoints were “decrease in mPASI score of ≥ 75% (mPASI-75; key secondary)” and “decrease in mPASI score of ≥ 90% (mPASI-90)” from baseline to week 4 (day 29) [14]. Exploratory efficacy endpoints were “percent change in mPASI,” “percent change in BSA,” “change in DLQI,” and “change in total PSI score”—all from baseline to week 4, and “having treatment success” (clear or very mild disease) according to SGA at week 4.

Statistics

The trial sample size calculation is described in the primary publication [14]. Efficacy analyses were based on the full analysis set (all patients randomized). Analysis of all protocol-defined endpoints (the week 4 outcomes described above) were prespecified in a statistical analysis plan; all other analyses (including those at week 2) were post hoc. All analyses were performed using SAS software (version 9.4). The clinical trial protocol and statistical analysis plan are accessible via https://clinicaltrials.gov/study/NCT05919082.

Continuous outcome measures at weeks 2 and 4 were analyzed using the treatment policy strategy for handling of intercurrent events (permanent discontinuation of trial drug); data were used as observed, and missing data were handled by multiple imputation (missing at random within treatment arms). Each imputed dataset was analyzed using an analysis of covariance (ANCOVA) model adjusted for baseline PGA and the baseline score corresponding to each outcome measure. The combined least square means, along with the associated 95% confidence intervals and nominal P-values, were calculated using Rubin’s rules [23]. Changes from baseline to weeks 2 and 4 were analyzed using a mixed-effects model for repeated measures with a compound symmetry covariance structure; analyses were performed on the imputed datasets, and the results were combined using Rubin’s rules [23].

Binary outcome measures at weeks 2 and 4 were analyzed using the composite strategy, as described in the primary publication for the primary and secondary endpoints [14]; data collected after permanent discontinuation of trial drug and missing data were imputed as nonresponse. For the primary and secondary efficacy endpoints, a closed testing procedure with hierarchical tests was used to control the overall type I error at a nominal two-sided 5% level [14].

For PSI, the score for each symptom (burning, cracking, flaking, itch, pain, redness, scaling, and stinging) at baseline and weeks 2 and 4 was summarized descriptively (as observed), in addition to analysis for total score. For PGA, the proportion of PGA 0/1 responders at weeks 2 and 4 was analyzed with and without a ≥ 2-point reduction from baseline and (at week 4 only) by subgroups for baseline PGA score (mild/moderate/severe). Furthermore, the distribution of patients across PGA severity categories over time was visualized with alluvial plots, generated using R software version 4.4.1 and package version 0.12.5 [24].

Results

Patient Characteristics

Overall, 604 patients were randomized; all were included in the full analysis set. Details on patient recruitment and disposition, treatment compliance, and use of concomitant treatments have been reported previously [14]. Baseline demographics and disease characteristics were similar in both treatment groups, and the majority of patients had moderate disease severity at baseline (Table 1).

Table 1.

Demographics and baseline characteristics

	Cal/BD foam N = 302	Cal/BD ointment N = 302
Age (years)	47.0 (19–78)	46.0 (18–79)
Sex
Female	78 (25.8%)	88 (29.1%)
Male	224 (74.2%)	214 (70.9%)
BMI (kg/m2)	25.05 (15.7–44.3)	25.40 (16.7–41.2)
Duration of psoriasis (years)	10.0 (1–47)	10.0 (1–45)
PGA
Mild	79 (26.2%)	77 (25.5%)
Moderate	196 (64.9%)	197 (65.2%)
Severe	27 (8.9%)	28 (9.3%)
mPASI	6.35 (2.1–17.4)	6.60 (1.8–22.8)
BSA (%)	5.0 (2–29)	5.5 (2–30)
DLQI	9.0 (0–30)	8.0 (0–30)
Total PSI score	11.0 (0–32)	11.0 (3–32)
SGA
Very mild	8 (2.6%)	5 (1.7%)
Mild	85 (28.1%)	94 (31.1%)
Moderate	176 (58.3%)	169 (56.0%)
Severe	33 (10.9%)	34 (11.3%)

Data are provided as n (%) or median (minimum–maximum). The possible range for mPASI is 0 to 64.8, for DLQI 0 to 30, and for total PSI score 0 to 32, with higher values indicating worse scores. Per inclusion criteria, affected BSA could range from 2% to 30%

BMI body mass index, BSA body surface area, Cal/BD 50 µg/g calcipotriol and 0.5 mg/g betamethasone dipropionate, DLQI Dermatology Life Quality Index, mPASI modified Psoriasis Area and Severity Index, N number of patients in full analysis set, n number of patients with an observation, PGA Physician’s Global Assessment of disease severity, PSI Psoriasis Symptom Inventory, SGA Subject’s Global Assessment of disease severity

Continuous Outcome Measures

At both week 2 and week 4, the mPASI, BSA, DLQI, and total PSI scores showed statistically significant reductions from baseline, reflecting substantial improvements, within both treatment groups (Fig. 1). For mPASI, the percent changes from baseline to week 2 and week 4 were statistically significantly larger with Cal/BD foam than with Cal/BD ointment (approximately 5 percentage points difference; Fig. 1 and Supplementary Table S3 [Electronic Supplementary Material]). For BSA, DLQI, and total PSI scores, the reductions from baseline were numerically slightly larger with Cal/BD foam than with ointment, but the differences between the groups were not statistically significant.

Fig. 1.

Continuous outcome measures: improvements from baseline to week 2 and week 4. Data were used as observed, and missing data were handled by multiple imputation. Data are shown as least square mean with 95% confidence interval (and for each treatment group plotted equidistantly on either side of week 2 and week 4). P < 0.05 for both treatments at week 2 and week 4 versus baseline; *P < 0.05 for Cal/BD foam versus Cal/BD ointment. The possible range for DLQI is 0–30 and for total PSI score 0–32, with higher values indicating worse scores. BSA body surface area, Cal/BD 50 µg/g calcipotriol and 0.5 mg/g betamethasone dipropionate, DLQI Dermatology Life Quality Index, mPASI modified Psoriasis Area and Severity Index, N number of patients in full analysis set, PSI Psoriasis Symptom Inventory

For PSI, scores for each symptom improved consistently from baseline through to week 4 in both treatment groups, with a marked increase already at week 2 in proportions of patients reporting no or mild symptoms. Improvements were most pronounced for itch, flaking, redness, and scaling, where a majority of patients reported moderate to very severe symptoms at baseline (Fig. 2).

Fig. 2.

Psoriasis Symptom Inventory (PSI) scores. Data are shown as observed. Number of patients: 302 in each treatment group (foam = Cal/BD foam; ointment = Cal/BD ointment). Cal/BD = 50 µg/g calcipotriol and 0.5 mg/g betamethasone dipropionate

Binary Outcome Measures

A substantial proportion of patients achieved PGA 0/1 with and without a ≥ 2-point reduction from baseline and mPASI-75, mPASI-90, and SGA treatment success at both week 2 and week 4 (Fig. 3 and Supplementary Table S4 [Electronic Supplementary Material]). The odds of achieving the binary PGA- and mPASI-based outcomes at week 4 were 40–50% higher with Cal/BD foam than with ointment (odds ratios of 1.4 and 1.5), and the corresponding differences between the groups were statistically significant (i.e., Cal/BD foam was superior to Cal/BD ointment on the primary and both secondary efficacy endpoints, as reported in the primary publication [14]). The odds of achieving SGA treatment success at week 4 was 30% higher with Cal/BD foam (odds ratio of 1.3), but the difference between the groups was not statistically significant.

Fig. 3.

Binary outcome measures: percentage of responders at week 2 and week 4. Data are shown as binomial proportion (after imputation) with 95% confidence interval (and for each treatment group plotted equidistantly on either side of week 2 and week 4); patients who permanently discontinued treatment prior to week 2/week 4 or whose scores were missing at week 2/week 4 were imputed as nonresponders. *P < 0.05 for Cal/BD foam versus Cal/BD ointment; P-values were obtained using a logistic regression model adjusted for baseline PGA and, for the mPASI- and SGA-based outcome measures, also adjusted for the corresponding baseline score. Cal/BD 50 µg/g calcipotriol and 0.5 mg/g betamethasone dipropionate, mPASI-75/mPASI-90 a decrease in modified Psoriasis Area and Severity Index of at least 75%/90% from baseline, N number of patients in full analysis set, PGA 0/1 score of 0 (clear) or 1 (almost clear) according to Physician’s Global Assessment of disease severity, SGA Subject’s Global Assessment of disease severity

The greater proportion of patients achieving PGA 0/1 without as opposed to with a ≥ 2-point reduction, as shown in Fig. 3, was solely due to patients with mild disease (PGA 2) at baseline. At week 4, the response rate in the mild subgroup was markedly higher for PGA 0/1 without than with a ≥ 2-point reduction from baseline (78.5% versus 21.5% with Cal/BD foam; Table 2).

Table 2.

PGA 0/1 responders at week 4 with and without ≥ 2-point reduction from baseline, by baseline disease severity

	Cal/BD foam (N = 302)	Cal/BD ointment (N = 302)	Cal/BD foam (N = 302)	Cal/BD ointment (N = 302)
	PGA 0/1 with ≥ 2-point reduction from baseline		PGA 0/1
Baseline PGA mild	17/79 (21.5%)	17/77 (22.1%)	62/79 (78.5%)	55/77 (71.4%)
Baseline PGA moderate	118/196 (60.2%)	107/197 (54.3%)	Same as for PGA 0/1 with ≥ 2-point reduction from baseline
Baseline PGA severe	16/27 (59.3%)	4/28 (14.3%)
All	151/302 (50.0%)	128/302 (42.4%)	196/302 (64.9%)	166/302 (55.0%)

Data are provided as the number of responders/total number of patients per subgroup (%)

Cal/BD 50 µg/g calcipotriol and 0.5 mg/g betamethasone dipropionate, N number of patients in full analysis set, PGA Physician’s Global Assessment of disease severity, PGA 0/1 score of 0 (clear) or 1 (almost clear) according to PGA

In patients with moderate (PGA 3) or severe (PGA 4) disease at baseline, the response rates for the PGA-based outcomes at week 4 were equally high with Cal/BD foam (approximately 60% in both moderate and severe subgroups), whereas with Cal/BD ointment, the response rate was much lower in the severe subgroup (14.3%; Table 2). As shown in Fig. 4, the improvement trajectory in the severe subgroup was more favorable with Cal/BD foam, showing a greater proportion of patients improving to mild disease at week 2, with further improvement at week 4. The distribution of patients across PGA severity categories from baseline through to week 4 showed overall greater improvement with Cal/BD foam than with Cal/BD ointment (Fig. 4).

Fig. 4.

Distribution of patients across severity categories according to PGA from baseline to week 2 and week 4. Cal/BD 50 µg/g calcipotriol and 0.5 mg/g betamethasone dipropionate, PGA Physician’s Global Assessment of disease severity

Discussion

For the PROs (DLQI, PSI, and SGA), substantial and clinically meaningful improvements from baseline were observed at week 2 and week 4 with both treatments. Point estimates for the PROs were consistently in favor of Cal/BD foam, although the differences between the groups were not statistically significant. Thus, both treatments were to a large extent considered efficacious by patients, providing rapid relief of symptoms. The clinical relevance of the effect on PROs is demonstrated by the mean changes from baseline in DLQI, showing an approximately 4-point reduction at week 2 and ≥ 5-point reduction at week 4. These changes represent meaningful improvements in HRQoL, as judged by the established minimal clinically important difference (MCID) of 4 points on the DLQI [25].

The overall pattern of improvements in PROs was consistent with the results for the investigator-assessed outcome measures (BSA, mPASI, and PGA), which also showed substantial improvements from baseline at both week 2 and week 4. Except for percent change from baseline in BSA, these measures all showed a statistically significant treatment difference in favor of Cal/BD foam at week 4; for percent change from baseline in mPASI, this was also the case at week 2.

All of the abovementioned results are consistent with the hypothesis that the efficacy of Cal/BD foam would be at least on par with that of Cal/BD ointment in Chinese patients. The results also support the previously reported superiority of Cal/BD foam over Cal/BD ointment on the primary and secondary endpoints in this RCT [14], which can be ascribed to the increased skin bioavailability of active pharmaceutical ingredients due to the aerosol foam formulation [26, 27].

Furthermore, the exploratory data and post hoc analyses presented herein are consistent with previously reported RCT results that show rapid onset of action, itch relief, and improved HRQoL in non-Chinese patients treated with Cal/BD foam versus foam vehicle or Cal/BD gel [11]. The generalizability of the results from the Chinese trial setting to the broader patient population is further supported by the large sample size and multicenter trial design.

The high efficacy of Cal/BD foam in patients with severe psoriasis is promising, showing a response rate on the primary endpoint of 59.3% with Cal/BD foam versus 14.3% with Cal/BD ointment. Of note, patients with severe disease (PGA 4) at baseline needed a 3-point reduction to achieve PGA 0/1, i.e., a further improvement than the 2-point reduction that patients with moderate (PGA 3) or mild (PGA 2) disease severity needed to achieve the primary endpoint. The lower response rate on the primary endpoint in patients with mild disease severity at baseline (Cal/BD foam: 21.5%; Cal/BD ointment: 22.1%) was not unexpected, since this subgroup had less room for improvement and also had to meet the most stringent success criterion of complete clearance (PGA 0) to achieve the primary endpoint. For patients with mild psoriasis, however, it is also clinically meaningful to achieve a score of almost clear (PGA 1), which entails no or barely perceptible plaque elevation, no or only residual surface dryness and scaling, and only light pink coloration. Notably, the majority of patients with mild disease severity at baseline achieved PGA 0/1, i.e., ≥ 1-point reduction, at week 4 (Cal/BD foam: 78.5%; Cal/BD ointment: 71.4%). This result is consistent with findings in a post hoc analysis of pooled data from previous RCTs with Cal/BD foam, demonstrating the clinical benefit of Cal/BD foam in patients with mild psoriasis [28]. Similarly, a prospective real-world study with Cal/BD foam in Korea showed that patients with mild psoriasis at baseline were more likely to achieve successful treatment outcomes after 4 weeks of treatment than patients with moderate or severe disease [29].

The high efficacy levels shown with Cal/BD foam across all baseline disease severities, coupled with the substantial proportion of patients who achieved PASI-90 (6.3% at week 2 and 33.1% at week 4), suggest that the treatment may delay or even circumvent the need for systemic therapy. This is supported by evidence-based recommendations for the use of Cal/BD foam in beyond-mild psoriasis, suggesting that Cal/BD foam as topical monotherapy can be an appropriate option even in some patients with severe psoriasis [30, 31].

Furthermore, the rapid improvements seen with Cal/BD foam in many of the outcomes that matter most to patients are likely to encourage treatment adherence, which is crucial for the initial marked reduction of the signs and symptoms of psoriasis as well as its long-term management. Treatment compliance in the Chinese RCT was high [14], suggesting that treatment with Cal/BD foam is well perceived by patients. High levels of patient adherence and satisfaction with Cal/BD foam have also been shown in several real-world studies [29, 32–36]. The recent prospective, noninterventional study by Torres et al. showed not only high levels of patient adherence and satisfaction but also substantial improvements in HRQoL, both after 4 weeks of daily treatment with Cal/BD foam and after twice weekly maintenance treatment for up to 6 months [36].

As the only topical therapy with authorized prescribing information allowing for twice weekly proactive maintenance treatment as well as once daily reactive treatment, Cal/BD foam can be considered a topical therapy of choice for both short-term flare treatment and long-term control of plaque psoriasis [13, 37]. This is now also supported in Chinese patients, showing consistent improvements in both clinician-reported and patient-reported efficacy outcomes, on par with or better than those obtained with Cal/BD ointment. The safety and tolerability profile for Cal/BD foam in the Chinese trial population is also consistent with results from overseas RCTs, showing comparable adverse events and laboratory results for Cal/BD foam and ointment, with very few dropouts due to adverse events, as reported in the primary publication [14].

Limitations

An active comparator trial design with two different formulations meant that all patients knew they received active treatment, and they were not blinded; this could have caused perception bias, potentially influencing the response to PROs. Post hoc analyses have inherent limitations related to their post hoc nature. The majority of patients in the trial had moderate disease at baseline, i.e., the mild subgroup and especially the severe subgroup were relatively small, which may limit the generalizability of the results in these subgroups.

Conclusions

In the exploratory analyses reported herein, Cal/BD foam showed rapid onset of action with clinically meaningful improvements in signs, symptoms, and HRQoL in Chinese patients with plaque psoriasis. Efficacy outcomes for Cal/BD foam were on par with or better than those obtained with Cal/BD ointment, a standard-of-care treatment for plaque psoriasis in China. Furthermore, Cal/BD foam showed high levels of efficacy across patients with mild, moderate, and severe disease at baseline. This is consistent with results previously reported for non-Chinese patients.

Supplementary Information

Below is the link to the electronic supplementary material.

Author Contributions

Lin Cai, Furen Zhang, Guoqiang Zhang, Yangfeng Ding, Yan Zhou, Shanshan Li, Juan Tao, Wei Yan, Rong Xiao, Bin Yang, Jianjun Qiao, Xiaoyong Man, Zaixing Wang, and Jianzhong Zhang: clinical trial conduct, data acquisition, and manuscript review; Adam El Mongy Jørgensen and Merle Kurvits: data analysis and interpretation, and manuscript preparation and review; Jens Strodl Andersen: concept and design of trial, data interpretation, and manuscript review. All the authors approved the manuscript, and the requirements for authorship as per the ICMJE recommendations have been met.

Funding

The clinical trial (including drug supply), all analyses presented in this article, the writing of this article, and the journal’s Rapid Service Fee were funded by LEO Pharma (Ballerup, Denmark), who also designed the trial and had a role in its conduct, data analysis, and reporting.

Data Availability

Anonymized patient-level data that support the findings of this study can be made available to researchers via a secured file transfer protocol upon reasonable request. The data are not publicly available owing to privacy or ethical restrictions.

Declarations

Conflict of Interest

Jianzhong Zhang has received consulting fees and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Pfizer Investment Co. Ltd., Novartis Pharmaceuticals (China), Sanofi China, LEO Pharma (Shanghai) Co. Ltd., GSK (China) Investment Co. Ltd., Eli Lilly and Company (China), Xi’an Jansen Pharmaceutical Ltd., Bristol-Myers Squibb (China) Investment Co. Ltd., Beijing Wenfeng Tianji Pharma Ltd., Keymed Biosciences (Chengdu) Ltd., Akeso Biopharma Co. Ltd., and Kintor Pharmaceutical Ltd. Adam El Mongy Jørgensen is an employee of LEO Pharma A/S; Merle Kurvits and Jens Strodl Andersen are shareholders and employees of LEO Pharma A/S. Lin Cai, Furen Zhang, Guoqiang Zhang, Yangfeng Ding, Yan Zhou, Shanshan Li, Juan Tao, Wei Yan, Rong Xiao, Bin Yang, Jianjun Qiao, Xiaoyong Man, and Zaixing Wang have nothing to disclose.

Ethical Approval

At each investigational site, an independent ethics committee reviewed and approved the clinical trial protocol and informed consent form. The Ethical Review Committee of Peking University People’s Hospital provided the principal approval; the names of the remaining ethics committees are provided in Supplementary Table S1. The trial was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice, with the patients’ understanding and written informed consent. There was no patient or public involvement in the design, conduct, or reporting of the trial.