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Background:
Humira (Adalimumab) approval by the European Medicines Agency on December 2007 as second-line therapy of moderate to severe chronic plaque psoriasis was based on scientific evidence from clinical trials, but patients in daily clinical practice are different and results may differ in different geographical settings.
Aims:
To analyse the efficacy, safety and retention of treatment with adalimumab in a cohort of patients with moderate to severe psoriasis at a referral centre in Barcelona, Spain.
Methods:
Retrospectively collected efficacy and safety data of a cohort of 119 consecutive patients treated with adalimumab for moderate to severe psoriasis in daily practice between January 2008 and March 2013. Efficacy was determined using as treated (AT) and intention-to-treat (ITT) analysis. Drug survival was analyzed by the Kaplan-Meier method with log-rank test and Cox regression.
Results:
One hundred and nineteen patients received adalimumab therapy with mean treatment duration of 25 months (median 25, range, 2-60). In 49 (41%) of our cases, adalimumab was the first biologic ever used. PASI75 response rates at week 16, 6 months and 1 year of treatment were 64%, 67%, and 76% (AT) and 64%, 60%, and 54% (ITT), respectively. The corresponding PASI90 response rates were 49%, 60%, and 70% (AT), and 49%, 52%, and 50% (ITT), respectively. Biologic naïve patients had significantly higher PASI75 and PASI90 response rates at week 16, 6 months, and one year of treatment. Combination treatment (used in 22% of our patients) was associated with increased PASI75 and PASI90 response rates at 6 months. The variables which were associated with a significantly higher probability of drug survival were PASI75 response status at week 16, 6 months and 1 year, PASI90 response status at 6 months and 1 year, and biologic-naïve status of the patient. The ability to lengthen and need to shorten injection intervals to maintain response were respectively associated with higher and lower probability of drug survival. Multivariate analysis using Cox regression model showed PASI75 response status at 1 year (P=0.002) and lengthening of injection intervals (P=0.015) as the only significant variables.
As regards safety, 48 adverse events (AE) occurred in 29 patients, and were serious in 8 patients (0.032 serious adverse events per patient-year). Paradoxical flares of psoriasis were seen in 3 patients and flares of arthritis in 2. Infections accounted for 53% of recorded AE and 88% of serious AE, and were the reason for discontinuation in 2 patients.
Conclusion:
The efficacy results are consistent with those of a previously published U.K. study. Even though biologic-naïve status and efficacy parameters denoting a good or excellent response at different time points appear to be associated with a higher probability of drug survival in this cohort of patients, PASI75 response status at 1 year and the ability to maintain response lengthening the injection intervals were the only independent variables predicting drug survival on multivariate analysis. Infections, including de novo infection by M. tuberculosis, accounted for most serious AE, and paradoxical flares of psoriasis and psoriatic arthritis are a relatively frequent occurrence in daily clinical practice.
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More on Humira: https://psoriasisclub.org/showthread.php...165#pid165
Humira (Adalimumab) approval by the European Medicines Agency on December 2007 as second-line therapy of moderate to severe chronic plaque psoriasis was based on scientific evidence from clinical trials, but patients in daily clinical practice are different and results may differ in different geographical settings.
Aims:
To analyse the efficacy, safety and retention of treatment with adalimumab in a cohort of patients with moderate to severe psoriasis at a referral centre in Barcelona, Spain.
Methods:
Retrospectively collected efficacy and safety data of a cohort of 119 consecutive patients treated with adalimumab for moderate to severe psoriasis in daily practice between January 2008 and March 2013. Efficacy was determined using as treated (AT) and intention-to-treat (ITT) analysis. Drug survival was analyzed by the Kaplan-Meier method with log-rank test and Cox regression.
Results:
One hundred and nineteen patients received adalimumab therapy with mean treatment duration of 25 months (median 25, range, 2-60). In 49 (41%) of our cases, adalimumab was the first biologic ever used. PASI75 response rates at week 16, 6 months and 1 year of treatment were 64%, 67%, and 76% (AT) and 64%, 60%, and 54% (ITT), respectively. The corresponding PASI90 response rates were 49%, 60%, and 70% (AT), and 49%, 52%, and 50% (ITT), respectively. Biologic naïve patients had significantly higher PASI75 and PASI90 response rates at week 16, 6 months, and one year of treatment. Combination treatment (used in 22% of our patients) was associated with increased PASI75 and PASI90 response rates at 6 months. The variables which were associated with a significantly higher probability of drug survival were PASI75 response status at week 16, 6 months and 1 year, PASI90 response status at 6 months and 1 year, and biologic-naïve status of the patient. The ability to lengthen and need to shorten injection intervals to maintain response were respectively associated with higher and lower probability of drug survival. Multivariate analysis using Cox regression model showed PASI75 response status at 1 year (P=0.002) and lengthening of injection intervals (P=0.015) as the only significant variables.
As regards safety, 48 adverse events (AE) occurred in 29 patients, and were serious in 8 patients (0.032 serious adverse events per patient-year). Paradoxical flares of psoriasis were seen in 3 patients and flares of arthritis in 2. Infections accounted for 53% of recorded AE and 88% of serious AE, and were the reason for discontinuation in 2 patients.
Conclusion:
The efficacy results are consistent with those of a previously published U.K. study. Even though biologic-naïve status and efficacy parameters denoting a good or excellent response at different time points appear to be associated with a higher probability of drug survival in this cohort of patients, PASI75 response status at 1 year and the ability to maintain response lengthening the injection intervals were the only independent variables predicting drug survival on multivariate analysis. Infections, including de novo infection by M. tuberculosis, accounted for most serious AE, and paradoxical flares of psoriasis and psoriatic arthritis are a relatively frequent occurrence in daily clinical practice.
Source: NO LINKS ALLOWED
More on Humira: https://psoriasisclub.org/showthread.php...165#pid165