Registry studies broadly describing the safety of systemic drugs in psoriasis are needed.
To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, ...etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.
The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort.
Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5).
Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered.
Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.
Data on the effectiveness and safety of a drug in real‐world clinical practice complement the evidence from clinical trials, which are carried out in a different setting. Little has been published on ...the effectiveness and safety of guselkumab in the treatment of psoriasis in clinical practice. The ojective of this study was to assess the effectiveness and safety of guselkumab at 24 weeks in patients with moderate to severe plaque psoriasis in routine clinical practice. A retrospective, multicentre study of adult patients with moderate to severe plaque psoriasis treated with guselkumab for at least 24 weeks was carried out in Spain. We studied 343 patients, 249 of whom were followed for 24 weeks. By week 24, the mean (SD) psoriasis area severity index (PASI) had decreased from 11.1 (7.3) to 1.7 (2.8) (−9.3; −10.2;‐8.4), 85.9% of the patients had achieved PASI score of 4 or less and 77.9% a PASI score of 2 or less. In terms of relative PASI response, 59.4% of the patients achieved a PASI‐90 response and 49.0% a PASI‐100 response. On multivariate analysis, two factors reduced the probability of a PASI of 2 or less at 24 weeks: a BMI ≥30 (OR, 0.44; 95% CI, 0.22–0.88) and a greater previous exposure to biologic therapy (OR, 0.69; 95% CI, 0.56–0.84). Adverse events were rare (9.9%) and led to withdrawal from treatment in only nine patients (2.6%) by the end of the follow‐up period. The results of this study confirm the high efficacy and safety of guselkumab indicated by the clinical trial data. In clinical practice, the absolute PASI score appears to be a better marker of response to treatment than the relative value.
Introduction
Etanercept (ETN), a highly effective biological agent for the treatment of psoriasis (PSO) and psoriatic arthritis (PsA), is widely used in Spain. However, evidence of its economic ...impact is limited, indicating the need for a systematic review of the economic assessments conducted on the use of ETN in the treatment of both PSO and PsA in Spain.
Methods
A systematic review was carried out in PubMed, Embase, Cochrane Library, Health Technology Assessment reports and not indexed sources up to November 2018. The inclusion criteria were economic evaluations (total and partial) and dose optimization studies published in English or Spanish on the use of ETN to treat PSO and PsA for ETN in Spain.
Results
A total of 402 publications were identified, of which 32 were selected for inclusion in the review; of these 32 publications, 81.3% analyzed PSO (14 full economic evaluations, 5 partial economic evaluations and 7 dose optimization studies) and 18.8% analyzed PsA (1 economic analysis and 5 dose optimization studies). The perspective of the Spanish National Health Service (NHS) was used in 90.0% (
n
= 18) of the full and partial economic evaluations. The time horizons ranged from 12 weeks to 2 years. Reductions in the Psoriasis Area and Severity Index (PASI) of 50, 75 and 90% (PASI 50, 75 and 90, respectively) were most commonly used as efficacy outcomes in the complete evaluations. The economic impact of ETN ranged from €9110–14,337/PASI 75 at 12 weeks (50 mg/week) to €82,279/PASI 90 at 2 years, depending on the health outcome, time horizon and ETN dose used. Only one study determined the cost of using ETN for the treatment of PSO (€29,430–52,367/QALY for dose 2 × 25 mg/week or 50 mg/week, respectively). Only one partial economic evaluation on PSA was identified (NHS perspective), resulting in an ETN annual cost of €8585/patient-year.
Conclusion
Consistent evidence on the economic impact of ETN for the treatment of PSO and PSA in Spain is lacking, mainly due to the highly heterogeneous methodology used and the broad range of outcomes found in the economic evaluations published to date.
Funding
Pfizer S.L.U.
Background
The term super responders defines a subset of patients with moderate‐to‐severe psoriasis that present a rapid and higher rate of response to biological treatments in comparison to the ...general population. Little scientific evidence to explain the behavior and clinical characteristics of these psoriatic patients has been published thus far. Its characterization could be important to improve therapeutic optimization and to identify the profile of patients that will respond efficiently to biological treatments.
Objectives
The main objective of this study was to evaluate and characterize the proportion of super‐responder patients (who achieved PASI = 0 at week 12 and 24) in a total of 87 patients with moderate‐to‐severe psoriasis treated with guselkumab. Also, our intent was to analyze and evaluate differences in response to guselkumab in absolute PASI, PASI 75, PASI 90, PASI 100, BSA, VAS pruritus, and DLQI between groups.
Results
A total of 14 out of 87 patients treated with guselkumab were characterized as SR. No differences in demographic characteristics were found. The percentage of patients reaching PASI 75, PASI 90, and PASI 100 were numerically greater for SR than N‐SR at week 12, 24, 36, and 52. These differences were more pronounced for PASI 100 > PASI 90 > PASI 75. SR performed better and faster to guselkumab treatment as assessed by absolute PASI, BSA, VAS pruritus, and DLQI. Statistically significant differences were found in absolute PASI, BSA, VAS pruritus, and DLQI between groups along the 52 weeks of study. No differences in drug survival were found between groups (P = 0.3326).
Conclusion
Our study demonstrated for the first time, in a real clinical practice setting, the presence of a subpopulation of patients that super respond to guselkumab at week 12 and 24 and maintain this efficacy for 52 weeks. Further research must be performed to identify basal specific characteristics of this SR population.
Background
Psoriasis is a chronic systemic disease that requires long‐term management. Despite data on follow‐up studies going back 5 years, little is known about the condition's sustainability based ...on patient profiles. The aim of this study was to analyze drug survival and discontinuation rates for secukinumab treatment under real‐world conditions.
Patients and Methods
Patients with moderate‐to‐severe plaque psoriasis treated in the dermatology department of five Spanish medical centers between 2015 and 2019 were included in our retrospective study. Drug survival was assessed with Kaplan–Meier analysis plots and multivariate regression.
Results
In total, 171 treated patients were retrospectively recorded and analyzed for 152 weeks (37.40% had been diagnosed with psoriatic arthritis PsA). The discontinuation rate in the PsA group was 14.10% vs. 12.10% among those who had no PsA. The mean survival time of discontinuation was 63 weeks for PsA vs. 65 weeks for no PsA (P = 0.913). Secukinumab's estimated mean survival in PsA patients was 86% (estimated mean survival time 130 weeks) vs. 88% (estimated mean survival time of 133 weeks) in non‐PsA patients (P = 0.676).
Conclusion
The mean survival time of patients in secukinumab treatment was comparable in all patient profiles and better than the data found in clinical trials and real‐life studies.
Dermal fillers are applied using a minimally invasive technique with a good safety profile. However, they can have side effects. We present the case of a patient who, 2 months after undergoing ...polycaprolactone (Ellansé
) injections, developed nodular facial and nodal lesions that were compatible with sarcoidosis on histology. This complication has not been previously described for polycaprolactone and could be the expression of an autoimmune syndrome induced by adjuvants.
Autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA) is a recently devised umbrella term for autoimmune diseases caused by adjuvants.Aesthetic procedures, which are increasingly common, may be a cause of ASIA syndrome.Polycaprolactone is a bioabsorbable polymer with a safe profile but can have adverse events, including systemic sarcoidosis.
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