Certolizumab is an Fc-free PEGylated tumor necrosis factor-alpha (TNFα) inhibitor recently approved for the treatment of moderate-to-severe plaque psoriasis, although there is limited real-world ...evidence on the effectiveness and safety in patients with plaque psoriasis treated with certolizumab. The objective of this article is to determine the effectiveness, drug survival, and safety, including pregnancy, childbirth, and lactation, of certolizumab in moderate-to-severe plaque psoriasis under real-world conditions.
This is a retrospective, multicenter, observational study performed in 15 hospitals in Spain. It evaluates the effectiveness and safety of certolizumab in plaque psoriasis in the clinical practice setting.
A total of 67 patients (73% female) were evaluated with a mean baseline Psoriasis Area Severity Index (PASI) of 8.9. At Week 12, the mean PASI was 2.3 (n = 67), 1.3 (n = 57) at Week 24 and 1.3 at Week 52 (n = 34). Absolute PASI < 3 was achieved in 69, 86, and 92% of patients at Weeks 12, 24, and 52, respectively, as observed. For its part, using the under-response imputation analysis, PASI < 3 at Weeks 12, 24, and 52 were achieved by 69, 73, and 49% of the patients, respectively. A total of 35 patients (52%) had concomitant psoriatic arthritis, and, in 24 of them, Disease Activity in Psoriatic Arthritis Score (DAPSA) was recorded at baseline, with a mean value of 17.9 which decreased to 8.2 at Week 12 (n = 22) and to 3.6 at Week 24 (n = 18). Certolizumab treatment was discontinued in 14 out of 67 patients (21%), due to lack/loss of cutaneous or articular effectiveness (n = 11) or patient decision (n = 2) or adverse event in only one patient who developed active tuberculosis. A lower baseline PASI hazard ratio (HR): 1.12 (1.02-1.23); P = 0.023 and a more significant reduction in PASI at Week 12 HR: 1.16 (1.07-1.27); P < 0.001 and Week 52 HR: 1.47 (1.11-1.96); P = 0.007 was shown to be significantly related with better survival for the entire follow-up period. Fourteen patients were treated during pregnancy and/or lactation without reporting adverse events in either the patient or the newborn.
Certolizumab consistently showed high effectiveness and drug survival rates in this real-life cohort. The safety demonstrated in clinical trials during pregnancy and lactation seems to be confirmed in clinical practice.
Secukinumab is a first-in-class interleukin 17A monoclonal antibody that has demonstrated an excellent safety and efficacy profile in phase 3 studies.
To evaluate the effectiveness of secukinumab in ...daily clinical practice and to understand the clinical and epidemiologic characteristics of patients treated with secukinumab in clinical settings.
In this multicenter prospective observational study, we recruited adult patients with moderate-to-severe plaque psoriasis from 12 hospitals in Spain during January-December 2016. These patients were treated with secukinumab and prospectively followed at 12-week intervals for 52 weeks.
In total, 158 patients were recruited to the study. A Psoriasis Area and Severity Index (PASI) score improvement ≥75% over baseline (PASI-75) was achieved by 57%, 83.5%, 89%, and 78.5% of patients at weeks 4, 12, 24, and 52, respectively. PASI-90 was achieved in 27.8%, 62%, 64.6%, and 63.2% of patients at weeks 4, 12, 24, and 52, respectively; PASI-75 and PASI-90 responders were significantly more common among patients with a body mass index <30 kg/cm2 and patients without previous biologic therapy failures.
Observational study. Time from onset of psoriasis was not evaluated.
Secukinumab is a safe treatment with effectiveness rates similar to those found in its phase 3 studies. These rates endure up to a year from start of treatment.
Limited information is available regarding the risk of incident liver disease in patients with psoriasis receiving systemic therapies.
To describe the liver safety findings of conventional and modern ...systemic therapies for moderate-to-severe psoriasis, and to compare the relative incidence rates of hepatic adverse events (AEs) for each drug.
All the patients on the BIOBADADERM registry were included. Crude and adjusted incidence rate ratios (cIRR and aIRR, respectively) of hepatic AEs, using anti-TNF drugs as reference, were determined. Outcomes of interest were hypertransaminasemia, nonalcoholic fatty liver disease (NADFLD) and a group of other, less represented, hepatic AEs.
Our study included 3,171 patients exposed to systemic drugs (6279 treatment cycles). Incident hypertransaminasemia was the most frequent hepatic AE (incidence rate of 21 per 1000 patients-years CI 95% 18-23), followed by NAFLD (8 cases per 1000 patients-years 95% CI 6-10). Methotrexate (aIRR 3.06 2.31-4.4; p = 0.000) and cyclosporine (aIRR 2.37 1.05-5.35; p = .0378) were associated with an increased risk for hypertransaminasemia when compared to anti-TNF-α agents. No differences were observed between different groups of biologics. Conventional therapies were not associated with new incident NAFLD.
Comparative information of the incidence of hepatic AEs could facilitate drug selection in moderate-to-severe psoriasis.
Celotno besedilo
Dostopno za:
DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Palmoplantar psoriasis (PP) is a special area of psoriasis, which can justify systemic treatment. Roflumilast is a targeted inhibitor of phosphodiesterase (IPDE)-4 that has been recently approved by ...FDA as a cream for the treatment of plaque psoriasis. Also, oral roflumilast has demonstrated efficacy in the treatment of plaque psoriasis in a small randomized clinical trial and single case reports. To the best of our knowledge, we present the first case series of PP treated with oral roflumilast.
Evaluate the relationship between structural damage assessed by radiography or ultrasonography in the hands of patients with psoriatic arthritis (PsA) with loss of strength together with functional ...disability.
A cross-sectional study was conducted in patients with PsA involving the hands. Erosions and loss of radiographic joint space were measured in the dominant hand using a modified Sharp van der Heijde method and an ultrasound assessment. Hand strength was assessed with a dynamometer and disability was assessed using the Health Assessment Questionnaire (HAQ). The statistical analysis was performed using multiple linear regression models.
76 patients were included with a mean age of 57 ± 9.9 years, with 56.6% women. A statistically significant relationship was found between presence of erosions and reduction in lateral (p = 0.027) and tip (p = 0.030) pinch strength in the hand. This was also the case for loss of joint space and reduction in lateral (p = 0.012) and tip (p = 0.006) pinch strength. There was an association between total ultrasound (US) alterations and reduction in lateral pinch strength (p = 0.03). An association was also observed between erosions, loss of joint space and total US alterations and disability measured by the HAQ (p < 0.001; <0.001; 0.012, respectively). HAQ scores were associated with a decrease in mean lateral (p < 0.001) and tip (p < 0.001) pinch strength.
In patients with PsA involving the hands, structural alterations of the dominant hand assessed by conventional x-ray and ultrasound are associated with loss of strength measured objectively with dynamometry and greater disability also studied subjectively using the HAQ.
•Higher scores for erosions and joint space narrowing in the radiography are related to the total HAQ score in a very similar way to loss of strength•In PsA patients, erosions and loss of joint space in the structures involved in the hand pinch action are associated with loss of strength, measured by dynamometry and greater disability measured by the Health Assessment Questionnaire.•The close relationship between Health Assessment Questionnaire score and mean strength measured by dynamometry reveals that measuring strength is a good instrument for studying disability, even in patients with intellectual or language difficulties, and either of the two methods can be applied interchangeably.
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