Israel Medical Association Journal

Background: There is a lack of real-life clinical data for biosimilar etanercept, an anti-TNF blocking fusion protein. We describe the comparable efficacy and safety of originator and biosimilar etanercept in rheumatoid arthritis (RA) patients in a real-life clinical setting. Our data confirm that a biosimilar etanercept can be safely used as first-line treatment as well as in patients switched from a previous originator compound.

Objectives: To compare the efficacy and safety of originator and biosimilar etanercept in a cohort of RA patients attending two Italian hospitals.

Methods: The study involved 81 consecutive adult RA patients treated for at least 6 months with originator or biosimilar etanercept and considered their clinical and laboratory data, concomitant medications, and adverse events at baseline, and after 3 and 6 months of treatment.

Results: Group 1 included 51 patients taking originator etanercept; group 2 included 30 taking biosimilar etanercept, including 19 who had been switched from the reference product. Despite a significant baseline difference in clinical disease activity, one-way analysis of variance showed that the two groups were clinically comparable after 6 months of treatment, and the same was true when only those receiving etanercept as first-line biological treatment were considered. Nine patients discontinued the treatment due to inefficacy or adverse events, which were never serious and were only reported in group 1.

Conclusions: The efficacy and safety profiles of originator and biosimilar etanercept are comparable in RA patients in a real-life clinical setting. Further studies are needed to confirm these preliminary findings

Background: Trabectedin is a marine-derived chemotherapy, which has received U.S. Food and Drug Administration approval for use in anthracycline-resistant advanced soft tissue sarcoma (STS), especially liposarcoma and leiomyosarcoma (L-sarcomas).

Objectives: To describe our 10 year real-life experience with trabectedin regarding safety and efficacy in a cohort of 86 patients.

Methods: In our study cohort, 46.51% were diagnosed with liposarcoma and 43.02% with leiomyosarcoma. A total of 703 cycles of trabectedin were given, with a median of five cycles per patient (range 1–59). Median overall survival was 13.5 months for the whole cohort, 11 months for liposarcoma patients (range 1–63), and 15 months for leiomyosarcoma patients (range 1–35).

Results: There was no statistically significant difference in progression free survival when stratified according to previous treatment lines given. Trabectedin exhibited a favorable safety profile, with only 22% requiring dose reductions. Grade 3 and higher toxicity was noted in 25% of the patients, mostly due to myelosuppression. There were no treatment-related deaths.

Conclusions: Trabectedin is a safe and effective drug for treating advanced STS. Our results reflect real-life data with patients receiving the drug as a third and even fourth line of treatment, or with a suboptimal performance status, yet achieving impressive clinical benefit rates and survival.

Background: Clinical research is needed to identify patients with axial spondyloarthritis (axSpA) who are more likely to be responsive to interleukin (IL)-17 inhibition.

Objectives: To evaluate short-term efficacy of secukinumab in the management of axSpA.

Method: Twenty-one patients (7 males, 14 females) with axSpA were consecutively treated with secukinumab. Laboratory and clinical assessments were based on erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP, and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Data were recorded at baseline and at a 3 month follow-up visit.

Results: The study was comprised of 21 patients. Both BASDAI and ASDAS-CRP showed a statistically significant reduction between the baseline and the 3 month visit (P < 0.0001 and P = 0.0005, respectively). During the laboratory assessment, ESR showed a significant decrease (P = 0.008) while CRP improvement did not reach statistical significance (P = 0.213). No statistical significance was observed between patients treated with secukinumab 150 mg vs. 300 mg in BASDAI (P=0.99), ASDAS-CRP (P = 0.69), ESR (P = 0.54), and CRP (P = 0.56). No significant differences emerged between the BASDAI (P = 0.15), ASDAS-CRP (P = 0.09), and CRP (P = 0.15) rates in biologic-naïve patients and those previously failing tumor necrosis factor-α inhibition. Conversely, ESR decrease was significantly higher in the biologic-naïve subgroup (P = 0.01). No adverse events were reported.

Conclusions: Secukinumab has proven remarkable short-term effectiveness, regardless of the biologic treatment line. A dosage of 150 mg proved to be appropriate in the clinical and laboratory management of axSpA.

Background: Subcutaneous allergen immunotherapy is effective in treating allergic airway disease. Disadvantages include immediate local and systemic adverse reactions and poor compliance.

Objectives: To obtain real-life efficacy and safety data through a prospective observational study of SIT[1] in the allergist's office.

Methods: We prospectively collected data from all patients with a diagnosis of allergic rhinitis and/or asthma and a specific immunoglobulin E-mediated sensitization to one or more aeroallergens who began SIT during the 2 year period 1 January 2005 to 31 December 2006. As part of the routine immunotherapy care patients were asked to complete a disease activity questionnaire before and yearly during the treatment. The primary outcome measure was the combined rhinitis and asthma symptoms scores. Data from patients completing at least 1 year of immunotherapy were analyzed.

Results: Altogether, 133 enrolled patients with a mean age of 22.7 years completed at least 1 year of SIT. The allergic rhinitis and asthma disease activity score decreased from a mean of 8.1 to 3.3 (rhinitis) and from 4.8 to 2.4 (asthma) on a 10 cm visual analogue scale after 1 year of SIT (P < 0.001 for all comparisons). Rhinitis medication use in all patients and asthma medication use in asthmatics decreased significantly. Mild local adverse reactions were almost universal. There were 11 patients (8%) who developed 14 immediate systemic, mild to moderate reactions. All reactions were successfully treated in the clinic; none required additional observation or hospitalization.

Conclusions: In the hands of experienced allergists subcutaneous allergy immunotherapy is a safe and efficacious option for patients with allergic rhinitis and asthma. 

Background: Based on the outcome of several randomized controlled trials, the orally active leukotriene receptor antagonist montelukast (Singulair®, Merck) has been licensed for treatment of asthma. The drug is favored for treating childhood asthma, where a therapeutic challenge has arisen due to poor compliance with inhalation therapy.

Objectives: To assess the efficiency of and satisfaction with Singulair® in asthmatic children under real-life conditions.

Methods: Montelukast was prescribed for 6 weeks to a cohort of 506 children aged 2 to 18 years with mild to moderate persistent asthma, who were enrolled by 200 primary care pediatricians countrywide. Four clinical correlates of childhood asthma – wheeze, cough, difficulty in breathing, night awakening – were evaluated from patients' diary cards.

Results: Due to under-treatment by their physicians, almost 60% of the children were not receiving controller therapy at baseline. By the end of the study, which consisted of montelukast treatment, a significant improvement over baseline was noted in asthma symptoms and severity, as well as in treatment compliance. The participating pediatricians and parents were highly satisfied with the treatment.

Conclusions: The results of this extensive study show that the use of montelukast as monotherapy in children presenting with persistent asthma resulted in a highly satisfactory outcome for themselves, their parents and their physicians.