Search

Background Psoriasis vulgaris is not easy to manage, even when mild. Knowledge of the efficacy of most topical therapies in this population is limited. Objective To assess the efficacy of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam in patients with mild psoriasis. Methods Post hoc analysis was performed on pooled data for subjects with mild psoriasis at baseline from 2 Phase 3 and 1 Phase 2 clinical trials. All subjects applied Cal/BD foam or vehicle foam once daily for at least 4 weeks. Efficacy assessments included treatment success (defined as IGA=0), mPASI, BSA, and the composite IGAeBSA score. Results Of the 848 subjects, 164 had mild psoriasis at baseline. Within this subpopulation of mild subjects, Cal/BD foam demonstrated significant efficacy over vehicle at week 4 in terms of the proportion of subjects achieving complete clearance of visible lesions (IGA=0). Significant improvements were also observed for mPASI, BSA, and IGAeBSA score. Limitations These post hoc analyses need to be confirmed with prospective studies. Conclusion Once-daily Cal/BD foam for 4 weeks demonstrated effectiveness in treating subjects with mild psoriasis, a population in which demonstration of treatment success can be difficult, because of the requirement for complete clearance of visible disease. Clinicaltrials.gov: NCT02132936, NCT01866163, and NCT01536938 J Drugs Dermatol. 2021;20(8):822-828. doi:10.36849/JDD.5743.

Background The product of the Physician Global Assessment and body surface area (PGA×BSA) is simpler to use than the Psoriasis Area and Severity Index (PASI), which lacks sensitivity in patients with mild psoriasis. Objective To compare the PGA×BSA versus the modified PASI (mPASI) for assessing disease severity and therapeutic response to calcipotriol/betamethasone dipropionate (Cal/BD) foam. Methods This post hoc analysis evaluated the efficacy of Cal/BD foam in mild, moderate, and severe psoriasis, as assessed by the PGA×BSA and mPASI, using data from 3 randomized controlled trials ( NCT01536886 , NCT01866163 , NCT02132936 ). Spearman correlation and Bland-Altman plots were used to compare the PGA×BSA with the mPASI. Results Proportions of patients receiving Cal/BD foam achieving 75% response for PGA×BSA and mPASI at weeks 1, 2, and 4 were similar and significantly greater than with vehicle (P ≤ .002 at all timepoints); at week 4, mean improvements were 51.0% and 50.7%, respectively. Spearman correlations for mild, moderate, and severe psoriasis were moderate to high between PGA×BSA and mPASI at baseline (r = .51, .72, and .86, respectively; n = 126, 465, and 58, respectively) and high at week 4 (r = .80, .81, and .89, respectively; n = 121, 452, and 58, respectively) (P Limitations Pooled data from different trials were not prespecified for post hoc analysis. Interrater reliability was not assessed. Conclusion Pooled data analysis showed that the PGA×BSA and mPASI correlation was higher with increasing psoriasis severity.

Background: Real-world data for actinic keratosis treatment in the United States is lacking. Objectives: To understand real-world treatment patterns for actinic keratosis by type and modality, and compare effectiveness and safety of therapies, either alone or in combination. Methods: Medical charts of 429 patients were identified; clinical and outcome data were analyzed. Results: The first treatment after the index diagnosis was most frequently a procedure, followed by a topical agent. Treatment with 5-fluorouracil, ingenol mebutate, imiquimod, cryotherapy, or cryotherapy plus one topical (CRYO+One Topical) reduced actinic keratoses by 66.0%, 69.3%, 72.5%, 72.9%, and 73.0%, respectively; ≥75% clearance (AKCLEAR 75) was achieved in 57.1%, 72.7%, 57.1%, 62.4%, and 62.0% of those patients. Treatment effectiveness was positively correlated with the number of baseline actinic keratoses for topical and for procedural plus topical combination treatments, but not for procedural treatments alone. Adverse reactions (ARs) were more common with cryotherapy (9.7%); local skin responses (LSRs) were more common with field-directed (18.5%-43.1%) and CRYO+One Topical therapy (21.3%). Limitations: This was a retrospective study of limited duration and population size. Conclusions: The most commonly used treatments for patients with 6 or more actinic keratoses were topicals and a procedure plus topical combination, which also achieved higher rates of complete clearance than a procedure alone. ARs and LSRs were few in frequency and type.

Background: The fixed-dose combination foam formulation of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) has demonstrated efficacy and a favorable safety profile for the treatment of plaque psoriasis. Recently, a topical lotion of the combination of halobetasol 0.01% plus tazarotene 0.045% (HP/TAZ) was approved for treating adult plaque psoriasis. Currently, no head-to-head studies have compared Cal/BD foam with HP/TAZ lotion. Objective: Compare the effectiveness and drug incremental cost per responder (ICPR) of Cal/BD foam vs. HP/TAZ lotion in moderate-to-severe plaque psoriasis. Methods: An anchor-based, matching-adjusted indirect comparison was conducted for PGA treatment success (Physician’s Global Assessment of “clear” or “almost clear,” [PGA 0/1] with at least a 2-point improvement) using individual patient data from 3 randomized clinical studies of Cal/BD foam and published data from 2 randomized, Phase 3 clinical studies of HP/TAZ lotion. The number needed to treat and ICPR were also calculated. Results: After reweighting of patients in the Cal/BD foam studies to match summary baseline characteristics of the HP/TAZ lotion study patients and anchoring to vehicle effect, 4 weeks of Cal/BD foam produced a significantly greater rate of treatment success than 8 weeks of HP/TAZ lotion treatment (51.4 vs. 30.7%; treatment difference = 20.7%, p Conclusions: The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis.

Background: It is unclear if there are any distinct AK patient populations that might respond best to a given treatment. Objective: To identify if a distinct subgroup of patients with AK might respond better to treatment with ingenol mebutate (IngMeb) versus diclofenac sodium (DS). Methods: Complete clearance of AK and mean lesion reduction at end of first treatment course and week 17 were evaluated within subgroups. Results: 502 patients (255 IngMeb; 247 DS) were included in the analysis. At week 17, complete clearance was achieved by more patients treated with IngMeb versus DS within the majority of patient subgroups, including patients with

Background Plaque psoriasis has significant impact on patients’ quality of life. Topical therapy is considered the treatment mainstay for mild‐to‐moderate disease according to guidelines. Calcipotriol/betamethasone dipropionate (Cal/BD) [0.005%/0.05%] aerosol foam is indicated for psoriasis vulgaris treatment in adults. Cal/BD foam trials demonstrated improved efficacy and similar safety in this population. Psoriasis treatment is complicated by the broad range of disease presentation, variability and therapeutic options; particularly decisions on transition from topical to non‐biologic systemic treatment are difficult. Assessing comparative effectiveness of treatment options provides meaningful value to treatment decisions. Objective To compare efficacy of Cal/BD foam individual patient data from pooled trials with efficacy of non‐biologic systemic treatments based on aggregated patient characteristics and treatment outcomes. Methods Individual data from four Cal/BD foam trials in 749 psoriasis patients were pooled to conduct matching‐adjusted indirect comparisons. Literature review identified non‐biologic systemic treatment trials where methods, populations and outcomes align with Cal/BD foam trials. Of 3090 screened publications, four studies of apremilast, methotrexate, acitretin or fumaric acid esters (FAE) were included. Results After baseline matching, patients treated with 4 weeks of Cal/BD foam had greater Physician's Global Assessment 0/1 response compared to those treated with 16 weeks of apremilast (52.7% vs. 30.4%; P

Early initiation of insulin therapy has widely been associated with numerous benefits, including improved glycaemic control and reduced long-term risk of developing microvascular diseases. Biphasic insulins offer a convenient option for insulin initiation, addressing both basal and postprandial insulin requirements with one injection, making them relatively simple for patients to dose. Development of biphasic insulin aspart (BIAsp) has further offered improved postprandial glycaemic control and lower rates of nocturnal and major hypoglycaemia than biphasic human insulin.The safety and efficacy of the 30/70 rapid-acting/intermediate-acting formulation of BIAsp (BIAsp 30) in patients with type 2 diabetes was examined in the IMPROVE study, a 26-week, international, observational trial. In this subanalysis, baseline clinical factors that predicted treatment success, defined as HbA1c7% (53 mmol/mol) without experiencing hypoglycaemia after 26 weeks on BIAsp 30 therapy, were assessed.The composite endpoint was defined for 44,010 (77%) patients from the total cohort of 57,478, and 28,696 of these were included in the statistical examination. The results of the analysis suggest that those with lower baseline HbA1c of ≤8% (≤64 mmol/mol), shorter duration of diabetes at baseline (5 years) and no incidence of major hypoglycaemia at 13 weeks, or minor hypoglycaemia at 4 weeks, before the beginning of the trial were more likely to achieve treatment success.Lower baseline HbA1c, shorter duration of diabetes and no incidence of hypoglycaemia up to 13 weeks prior to initiation are predictors of achieving HbA1c7% without hypoglycaemia with a BIAsp 30 regimen. These results suggest that it is easier to reach target without hypoglycaemia with BIAsp 30 when prescribed earlier. As this was an observational study, lack of control groups or randomisation, as well as varying clinical practices in study countries, potentially introduced bias.ClinicalTrials.gov NCT00659282.

To evaluate if improvements in the quality of diabetes care in Indian clinics can be obtained by simple self-surveillance PC-based software. Method Nineteen Indian diabetes clinics were introduced to the principles of quality assurance (QA), and to a software program, the Steno Quality Assurance Tool (SQAT). Data was entered for an initial 3 months period. Subsequently data were analyzed by the users, who designed plans to improve indicator status and set goals for the upcoming period. A second data entry period followed after 7–9 months. Results QA data was analyzed from 4487 T2DM patients (baseline) and 4440 (follow-up). The average examination frequency per clinic of the following indicators increased significantly: lipid examination (72–87%) ( p =0.007), foot examination (80–94%) ( p =0.02), HbA1c investigation (59–77%) ( p =0.006), and urine albumin excretion investigation (72–87%) ( p =0.006). Outcome parameters also improved significantly: mean (SD) fasting and post prandial BG reduced from 144(16) to 132(16)mg/dl ( p =0.02) and 212(24)–195(29)mg/dl ( p =0.03), respectively. Systolic BP reduced from 139(6) to 133(4) ( p =0.0008)mmHg and diastolic BP from 83(3) to 81(3)mmHg ( p =0.002). Conclusion Quality of diabetes care can be improved by applying SQAT, a QA self-surveillance software that enables documentation of changes in process and outcome indicators.

The relationship between fasting glucose (FG) variability and nocturnal hypoglycemia was assessed using longitudinal data from PREDICTIVE, the large-scale observational study of insulin detemir. An HbA(1c)-corrected correlation was found between these endpoints, suggesting FG variability can serve as a useful marker for this risk in clinical practice.

Anti-tumor necrosis factor (TNF) therapy is known to decrease disease activity of juvenile idiopathic arthritis (JIA), but its effect on longitudinal growth in relation to puberty is not clear. We studied longitudinal growth in response to etanercept treatment in prepubertal and pubertal patients with JIA.Out of 52 children treated with etanercept, we studied 20 prepubertal and 11 early/midpubertal patients adherent to treatment for at least 1 year. We collected data on growth and glucocorticoid medication and calculated each patient's height standard deviation score (SDS) in relation to the mid-parental height, the change of this value (DeltahSDS) from 1 to 0 and 0 to 1 year of treatment, and the change between the DeltahSDS values to assess growth improvement.In the prepubertal group, the relative height SDS (mean +/- standard error of the mean) was 1.8 +/- 0.2, 2.1 +/- 0.3, and 1.9 +/- 0.3, and in the pubertal group 1.1 +/- 0.4, 1.3 +/- 0.3, and 1.1 +/- 0.3 at 1, 0, and +1 year of treatment, respectively. The DeltahSDS before etanercept was 0.3 +/- 0.1 in prepubertal and 0.2 +/- 0.2 in pubertal patients. Over the first year with etanercept, DeltahSDS was +0.2 +/- 0.1 in prepubertal (p = 0.001 vs before etanercept; paired Student t-test) and +0.2 +/- 0.1 in pubertal patients (p = 0.071). Nevertheless, most prepubertal (17/20) and pubertal (8/11) patients had improved growth (DeltahSDS) in response to etanercept treatment when analyzed individually. The need for intraarticular glucocorticoid injections was negatively correlated to the improved growth (p = 0.001).TNF inhibition with etanercept improved growth in a majority of patients with JIA. Our data demonstrate that growth improvement with etanercept was independent of the pubertal growth spurt.