No significant differences were found in ACR50 responses to the four drugs after 24 weeks. Injection-site reactions were more common with etanercept, but this was insufficient to invalidate the inference that clinically the four drugs can be regarded as clinically equivalent for the treatment of psoriatic arthritis.
Background
Intravenous immunoglobulins (IgIV) represent a therapeutic option with high cost and limited availability. As a consequence it is necessary to evaluate their use basing it on the scientific evidence and prioritising the indications.
Purpose
To examine the suitability of immunoglobulin prescriptions regarding the indication and recommended dose.
Materials and methods
We studied patients treated with IgIV between January 2012 and June 2013. We checked the prescriptions against The Clinical Guidelines for Immunoglobulin Use edited by the British Department of Health. We recorded the prescribing department, indication for the prescription, dosing regimens and approved or non-approved indications.
Results
A total of 34 patients were treated with a standard dose of 0.4 g/kg, 44% of prescriptions came from Haematology, 24% from Oncology, 15% Immunology, 9% Neurology and 8% from other services. The distribution of patients according to the prescribing indication was: idiopathic thrombocytopenic purpura (38%), primary immunodeficiencies (23%), secondary immunodeficiencies (15%), autoimmune haemolytic anaemia (6%), Rasmussen’s syndrome (3%) and others (15%). 91% of the prescriptions were for an approved indication, 3% were approved but not scientifically supported and 6% not approved or accepted. The most frequent patterns were 30 g for 4 days and 35 g every 28 days.
Conclusions
Most of the prescriptions written were for approved indications. A low percentage of prescriptions were for unapproved indications, which were required as compassionate use. The pattern and duration of treatment were appropriate to the treated pathologies.
No conflict of interest.
Background
The new protease inhibitors (PIs) have proved effective in increasing the rate of Sustained Virological Response (SVR) in hepatitis C, 25%-30% better than standard treatment. However, triple therapy is associated with undesirable effects: skin rash (telaprevir), anaemia (telaprevir and boceprevir) and taste disorder (boceprevir).
Purpose
To analyse effectiveness and safety with telaprevir and boceprevir in patients with hepatitis C, who met the inclusion criteria established by the Spanish Health Ministry and profile of these treatments.
Materials and methods
The study period started after the inclusion of PIs in the pharmacotherapeutic guide. Patients who met the inclusion criteria were selected: Genotype 1, treatment-naïve or previously treated, F4 fibrosis stages in biopsy or FibroScan >9.5 Kilopascals, haemoglobin concentration >12 g/dl in women and >13 g/dl in men and compensated liver disease. Effectiveness was assessed based on SVR of triple therapy, at weeks 4 and 12 with telaprevir and at weeks 8 and 24 with boceprevir. SVR was defined as undetectable viral RNA in these weeks. Safety was assessed based on adverse events recorded in the clinical history or during the therapeutic drug monitoring.
Abstract DI-012 Table 1
Viral Load at week 4
Viral Load at week 12
Viral Load at week 8
Viral Load at week 24
Adverse events
Telaprevir(14 patients)
71% detectable29% undetectable
93% undetectable7% detectable
Not applicable
Not applicable
21% skin rash29% ano-rectal discomfort43% anaemia
Boceprevir(3 patients)
Not applicable
Not applicable
100% undetectable
1 undetectable2 not reached
100% taste disorder14% ano-rectal discomfort14% anaemia
Results
A total of 20 patients (59% relapsers, 23% treatment-naïve, 12% non-responders and 6% partial responders) started treatment with PIs (16 telaprevir and 4 boceprevir). All patients met the inclusion criteria. Three patients were excluded due to not adequately following the protocol, withdrawal of medicines for adverse event (pancreatitis for telaprevir) and non recording of the viral load in the clinical history. Blood transfusion and rescue treatment with darbepoetin alfa was performed in 3 patients.
Conclusions
The rate of effectiveness achieved was higher than in clinical trials. However the main limitations of the study were the small sample size and the insufficient follow-up period.
Overall, the main adverse events were anaemia and taste disorders with telaprevir and boceprevir respectively. These results were similar to those of previous reports.
No conflict of interest.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.