Daily Practice Cohort Research Articles

Alitretinoin and acitretin in severe chronic hand eczema; results from a retrospective daily practice study

Acitretin has been used off-label for years to treat chronic hand eczema, but acitretin is less often prescribed as alitretinoïne was approved. This study evaluates both retinoids in a daily practice cohort of patients with severe chronic hand eczema in terms of drug survival and reasons for discontinuation. Patients using alitretinoin or acitretin between 01-01-1994 and 01-08-2015 were included in this retrospective daily practice study and analyzed by Kaplan-Meier drug survival curves. Potential determinants were analyzed by Cox regression analyses. Ninety-five patients were treated with alitretinoin and 109 patients with acitretin. The main reasons for discontinuation were adverse events and cleared hand eczema, 29.5 and 27.4% in alitretinoin versus 43.1 and 23.9% in acitretin. Patients with hyperkeratotic hand eczema had most often a good effect of treatment: 68.3% in alitretinoin and 50.7% in acitretin treatment. The drug survival rates of alitretinoin and acitretin after 12, 24, 36, and 52 weeks were 69.3, 45.1, 19.6, 7.0% and 74.3, 45.5, 33.8, 23.2%, respectively. Alitretinoin and acitretin are effective treatment options for patients with hand eczema. However, both treatments were more effective in patients with hyperkeratotic hand eczema. Fewer patients discontinued alitretinoin compared with acitretin due to adverse events.

Developing a Therapeutic Range of Adalimumab Serum Concentrations in Management of Psoriasis: A Step Toward Personalized Treatment.

Adalimumab has proven to be effective in suppressing psoriasis disease activity and is administered in a standard dose. To establish a therapeutic range for adalimumab trough levels in the treatment of plaque-type psoriasis, leading to a more personalized treatment. A multicenter, prospective, observational, daily practice cohort study conducted at an academic hospital with affiliated secondary care hospitals in Belgium (cohort 1) and 2 academic hospitals in the Netherlands (cohort 2). Both cohorts included adult patients treated with adalimumab for plaque-type psoriasis. Cohort 1 comprised 73 patients who were being treated with adalimumab for more than 24 weeks until 401 weeks. In cohort 2 (n = 62), serum samples were obtained between weeks 24 and 52 of treatment. Before the start of adalimumab therapy and at time of serum sampling, Psoriasis Area and Severity Index (PASI) scores were determined. Adalimumab trough level and PASI score at the time of serum sampling to determine the receiver-operator characteristics analyses and concentration effect curve. By means of receiver-operator characteristics analyses with an area under the curve of 0.756 (SD, 0.046; 95% CI, 0.666-0.847) and a sensitivity of 78% and a specificity of 70%, 3.51 mg/L was established as the lower margin for the therapeutic range. By means of a concentration effect curve, 7 mg/L was established as the upper margin. One-third of patients had an adalimumab trough concentration exceeding 7 mg/L. A therapeutic range of adalimumab trough levels of 3.51 mg/L to 7.00 mg/L, which corresponds to an optimal clinical effect, was identified. In one-third of patients, it was observed that trough concentrations exceeded the therapeutic window. Based on the established range, a therapeutic algorithm for adalimumab treatment for patients with psoriasis can be developed and validated in a prospective patient cohort. By identifying this range, a step has been taken toward a more rational use of biological therapy in psoriasis. Developing a therapeutic algorithm may lead to less overtreatment of patients and cost savings.

Drug survival for adalimumab in a long-term daily practice cohort of patients with psoriasis

Drug survival for adalimumab in a long-term daily practice cohort of patients with psoriasis

Drug survival of cyclosporine in the treatment of hand eczema: a multicentre, daily use study.

Hand eczema is a common condition; it is often chronic and can be difficult to treat. Cyclosporine is used off-label to treat severe hand eczema; however, the evidence for this treatment is scarce. To examine the drug survival of cyclosporine in a daily practice cohort of patients with chronic hand eczema. This retrospective daily use study included hand eczema patients who were treated with cyclosporine between 01-06-1999 and 01-06-2014 in two Dutch university hospitals. Patient and treatment characteristics were retrospectively collected from medical charts. First treatment episodes were analysed by means of Kaplan-Meier drug survival curves. Possible determinants of drug survival were analysed by Cox regression models. Treatment effectiveness was analysed with a retrospective physician's global assessment. A total of 102 patients were treated with cyclosporine. The median drug survival rate was 0.86 years (10.3 months). The overall drug survival rate after 6 months, 1, 2 and 3 years were 61.7%, 45.2%, 18.6% and 13.9% respectively. Main reasons for discontinuation were adverse events, especially early in treatment, and ineffectiveness. After 3 months, a good response to treatment was recorded in 62.9% of the patients. Cyclosporine had a median drug survival of 10.3 months. Especially patients with recurrent vesicular hand eczema showed a good treatment response.

Methotrexate in pediatric plaque-type psoriasis: Long-term daily clinical practice results from the Child-CAPTURE registry

Background: Evidence on effectiveness and safety of methotrexate (MTX) in pediatric psoriasis is scarce. Objectives: To study the effectiveness and safety of MTX in pediatric plaque-type psoriasis and its influence on quality of life (Qol) in daily clinical practice. Methods: Subset analysis of prospectively collected data extracted from the Child-CAPTURE registry, a single center, longitudinal, long-term, observational daily practice cohort of pediatric psoriasis patients. A maximum dose between 0.14 and 0.63 mg/kg once weekly was prescribed in 25 children. Primary endpoints were percentages of patients with ≥ 75% improvement in the Psoriasis Area and Severity Index (PASI) at week 12 and 24. Results: PASI75 was achieved in 4.3% and 33.3% of patients at week 12 and 24, whereas 40% and 28.6% reached PASI 75 at week 36 and 48. Median PASI and body surface area decreased from 10.0 (range 3.8–42.4) and 11.0 (range 3.5–72.0) at baseline to 4.3 (range 0–19.8) and 2.6 (range 0.0–39.6) at week 24, respectively. Physician Global Assessment improved significantly from 3.0 to 1.2 at week 24. A significant decrease in Children’s Dermatology Life Quality Index from 9.0 to 3.8 at week 24 was found. Most reported adverse events were severe nausea (n = 5), infections requiring antibiotics (n = 5) and tiredness (n = 4). Conclusions: MTX shows a positive effect on PASI scores, improves Qol and has a reasonable safety profile.

Comparing treatment goals for psoriasis with treatment decisions in daily practice: results from a prospective cohort of patients with psoriasis treated with biologics: Bio CAPTURE

Treatment goals have been developed to optimize daily clinical practice psoriasis care, but have not yet been studied in real life. To investigate to what extent treatment decisions made by dermatologists in daily clinical practice for patients with psoriasis on biologics are already in accordance with treatment goals without the active application of the treatment goals algorithm. Data were extracted from a prospective daily practice cohort of patients with psoriasis on biologics. Analysis was done on effectiveness (Psoriasis Area and Severity Index score) and quality of life (Dermatology Life Quality Index questionnaire). Treatment decisions such as dosage adjustments, combination treatments, or switching therapy were compared with the treatment goals algorithm. In 64% (253 of 395) of visits, physicians followed the treatment goals algorithm. There were 162 (41%) visits in which there should have been a treatment modification according to treatment goals (group Modify) and a modification was indeed made in 59 of these 162 visits (36%). In 233 (59%) visits no treatment modification was necessary (group Continue) and therapy was indeed not modified in 194 of 233 visits (83%). Physicians acted in accordance with treatment goals in the majority of patient visits. In the patient group not achieving these goals, physicians should have modified therapy according to treatment goals but continued the same therapeutic regimen in the majority of visits. Optimizing therapy and defining barriers in the latter group might increase treatment results in daily practice psoriasis care.

Treatment of paediatric scalp psoriasis with calcipotriene/betamethasone dipropionate scalp formulation: effectiveness, safety and influence on children's quality of life in daily practice

Evidence on efficacy and safety of topical treatments for paediatric scalp psoriasis is lacking. This study aims to evaluate the effectiveness and safety of calcipotriene/betamethasone dipropionate scalp formulation for paediatric scalp psoriasis in daily clinical practice. The influence of this formulation on the quality of life (QoL) was assessed as well. Data of children treated with the scalp formulation were extracted from a prospective observational daily clinical practice registry of children with psoriasis, called Child-Continuous Assessment of Psoriasis Treatment Use Registry. Severity was expressed by Psoriasis Scalp Severity Index (PSSI) and the impact on the QoL was reflected by the validated Children's Scalpdex in Psoriasis (CSP). Eighty-four treatment episodes were analysed. Significant improvements of PSSI score (18.7 ± 11.8 to 12.7 ± 9.4) were demonstrated in the first 12 weeks and this result was well maintained during 48 weeks of follow-up. Three patients (4.1%) developed striae of the skin (arms, trunk and legs), which are possibly related to the scalp formulation. CSP scores (79.0-46.3) declined significantly after 3 months. In a daily clinical practice cohort of children with scalp psoriasis, calcipotriene/betamethasone dipropionate scalp formulation was effective with a 32.1% improvement of PSSI at week 12 and a maintenance of this effect until 48 weeks of follow-up, in combination with improvement of QoL.

Determinants of drug survival for etanercept in a long‐term daily practice cohort of patients with psoriasis

Long-term data of etanercept drug survival in patients with psoriasis in daily practice are scarce. The primary objective was to describe drug survival for etanercept in a long-term daily practice cohort of patients with psoriasis. The secondary objective was to identify determinants of drug survival for etanercept in general and separately for discontinuation due to adverse events or ineffectiveness of therapy. Data were extracted from a prospective daily practice cohort of patients treated with biologics for psoriasis. Drug survival was analysed by Kaplan-Meier survival curves and split for two reasons for discontinuation: adverse events and ineffectiveness. Determinants of drug survival were analysed using univariate Cox regression analysis and multivariate Cox regression analysis with backward selection. We included 193 patients (512 patient-years treated) with a maximum treatment duration of 7·5 years. The overall drug survival rates were 77%, 41% and 30% after 1, 4 and 7·5 years, respectively. The mean survival duration was 3·8 years (95% confidence interval 3·4-4·3). Reasons for discontinuation were ineffectiveness (33·7%), adverse events (11·9%), both ineffectiveness and adverse events (4·7%) or other reasons (e.g. pregnancy planned) (5·7%). Determinants related to longer general drug survival were male sex [hazard ratio (HR) 0·55], prior anti-tumour necrosis factor (TNF)-α use (HR 0·57) and lower etanercept dose (HR 0·65). Younger age (HR 0·83), lower body mass index (HR 0·63) and lower etanercept dose (HR 0·71) were related to a decreased risk of discontinuation due to side-effects. A lower mean weekly dose of etanercept (HR 0·63) was related to a decreased risk of discontinuation due to ineffectiveness of therapy. We present the longest analysis of drug survival for etanercept in psoriasis to date. Determinants of longer overall etanercept drug survival were male sex, prior anti-TNF therapy and lower etanercept dose. The determinants of longer drug survival depended on the reason for discontinuation of etanercept.

The Belgian MIRA (MabThera In Rheumatoid Arthritis) registry: clues for the optimization of rituximab treatment strategies.

IntroductionThis study describes the results of the Belgian 'MabThera In Rheumatoid Arthritis (MIRA)' registry: effectiveness, safety and evaluation of the current retreatment practice on the background of the Belgian reimbursement criteria for rituximab.MethodsAll Belgian rheumatologists had the possibility to participate in the study. Patients entered the registry in November 2006 and the entry is still open.ResultsBy mid-September 2009, 401 patients had entered the registry with a mean follow-up time of 70 weeks. Overall, DAS28-ESR decreased from 6.0 at baseline to 4.2 at week 16. Further decrease of disease activity was observed at the end of year 1 and year 2 with mean DAS28-ESR of 4.0 and 3.7 at these respective time points. More than 80% of patients showed a EULAR response at week 16. Patients could be retreated if they had DAS scores of > 3.2 at least 6 months after the previous course. Second and third courses were given in 224 and 104 patients, respectively. At month 6 after the second course, significantly lower DAS28-ESR values were observed compared to the first course. This was especially the case for patients who were retreated before they showed an obvious flare (DAS increase > 1.2).ConclusionsThis study describes the follow-up of a daily clinical practice cohort of 401 RA patients with long-standing refractory disease treated with rituximab. Relatively high DAS28 values at the start of each retreatment, compared to values 6 months after each treatment course, were noted. Moreover, further decrease of DAS28 scores after the second course was significantly more pronounced in those patients who didn't show an obvious flare. These two elements suggest that treatment of RA patients with rituximab could be optimized by earlier retreatment.

Effectiveness of β‐blocker therapy in daily practice patients with advanced chronic heart failure; is there an effect‐modification by age?

The effects of beta-blockers in daily practice patients with advanced chronic heart failure (CHF) and a broad range of ejection fraction (EF) are not well established. We aimed to assess, first, the association between beta-blocker prescription at discharge and mortality in a cohort of patients with advanced CHF, and second, whether this association is modified by the age of the patient. Patients diagnosed with advanced CHF (n = 625) were prospectively followed after discharge from the Cardiology Department. The mean age was 76 years, 53% male, mean EF 42 +/- 16%. Overall, 308 (49%) patients had a beta-blocker prescribed at discharge, 140 (22%) low-dose and 168 (27%) high-dose therapy. We used multivariate Cox analysis to assess the association between beta-blocker use at discharge and mortality. After a mean follow-up of 22 months, 117 (27%) patients died. Prescription of a beta-blocker was associated with a 45% relative risk reduction (hazard ratio 0.55, 95% confidence interval 0.39, 0.78). The relative risk reduction was similar with low and high doses of beta-blockers (42% and 49%). However, the relative risk reduction was higher in younger than in older patients (P = 0.006). In patients < or = 75 years old prescription of a beta-blocker was associated with 71% risk reduction, whereas in patients >75 years old it was associated with 21% risk reduction. In this daily practice cohort of patients with advanced CHF, prescription of a beta-blocker was associated with significant mortality reduction. However, the beneficial effects of beta-blockers appear to be greater in younger patients.