Biosimilars and access to biologic therapy in immune-mediated diseases.

BACKGROUND: The rise of biologic agents has been a major breakthrough in treating immune-mediated inflammatory diseases (IMIDs). However, their high cost underscores the need for strategies to optimize treatment efficiency. Biosimilars offer cost-effective alternatives to biologics. This study aimed to assess biosimilar drug availability's impact on biologic therapy access for IMIDs. RESEARCH DESIGN AND METHODS: A retrospective observational study in 15 Spanish hospitals analyzed IMID patients (arthropathies, inflammatory bowel disease and psoriasis) initiating biologic therapy with originator or biosimilar drugs (infliximab, etanercept, adalimumab). Time to availability and initiation of biologic therapy were assessed. RESULTS: 267 patients were included, with 58.4% starting on biosimilars. The mean time to availability of the biologic drugs in the hospitals was 15.9 ± 6.7 months, (20.0 ± 12.4 for originator and 11.8 ± 5.2 for biosimilars). Mean time to biologic treatment was 7.7 ± 9.0 years (8.6 ± 8.9 for originators and 7.0 ± 9.0 for biosimilars). Showing statistically significant differences among conditions. CONCLUSION: The emergence of biosimilar drugs has enhanced market competition and accelerated their adoption into hospitals' therapeutic regimens over original reference drugs. This has significantly improved access to biologic therapy for patients with IMIDs, evidenced by a notable 1.6-year reduction in access time for biosimilar drugs.

Current situation of carboplatin desensitisation protocols in the hospitals of Spain.

Desensitisation protocols allow the continuation of treatment in patients who have presented hypersensitivity reactions. Carboplatin desensitisation solutions are usually prepared in the chemotherapy centralised units of hospital pharmacies and they are diluted under the established concentration limit to guarantee the stability of the preparation. An online survey was sent to hospital pharmacies, inquiring about local desensitisation protocols: reasons for use of desensitisation protocols, the protocols used and the stability given to carboplatin solutions. An important variability among the hospitals in carboplatin desensitisation practice was detected. Six different carboplatin desensitisation protocols were described and discordance with the storage period of the carboplatin solutions was observed. The lack of consensus on which protocol must be followed and data supporting the stability of the diluted product, contribute to distrust of carboplatin desensitisation protocols. Although the efficacy and safety of carboplatin desensitisation protocols has been widely demonstrated, many professionals still have concerns.

Stability of daptomycin reconstituted vials and infusion solutions.

OBJECTIVES: Daptomycin is a cyclic lipopeptide with selective action against drug-resistant Gram-positive bacteria. The stability of daptomycin solutions in different containers while stored at different temperatures was assessed. METHODS: Daptomycin vials were reconstituted with NaCl (50 mg/mL). Daptomycin infusion solutions (5.6 and 14.0 mg/mL) were prepared in polypropylene infusion bags. All test solutions were stored either under refrigeration or at room temperature over 7 days. Samples were withdrawn on days 0, 2, 4 and 7 and assayed in triplicate using a stability-indicating high-performance liquid chromatography (HPLC) method. RESULTS: The HPLC analysis revealed no significant loss in daptomycin concentration in vials or bags when stored at 2-8°C. All samples remained clear and colourless and there were no significant changes in pH throughout the study period. CONCLUSIONS: Reconstituted daptomycin vials (50 mg/mL) and infusion bags (5.6 and 14 mg/mL) were found to be physicochemically stable over a period of 1 week when stored at 2-8°C.

Ethanol-induced symptoms in patients receiving gemcitabine diluted from a concentrate for solution for infusion containing ethanol.

Purpose Ethanol as an excipient is used to enhance the solubility of gemcitabine, but, sometimes, the dose of ethanol a patient may be given is much higher than the dose considered to be toxic. We aimed to assess ethanol-related symptoms and signs in patients receiving two formulations of gemcitabine, with and without ethanol. Methods A randomized double blind cross-over study was conducted. All patients being treated with gemcitabine received two consecutive doses of the drug, one diluted from a concentrate for solution for infusion (CSI) containing ethanol and the other from a lyophilized powder, without ethanol, which was used as control group. After each administration, patients were surveyed in order to assess the appearance of any alcohol consumption symptoms (dizziness, difficulty speaking, unsteady walking, impaired balance, mood swings and slower reactions). Widmark formula and the amount of alcohol measured on the breath (breathalyzer) were used to estimate blood alcohol concentration. Results Twenty-four patients received both formulations and were included in the analysis. Mean administered ethanol dose when prepared from CSI was 15.81 ± 2.25 g (mean ± SD). When using CSI gemcitabine, estimated blood ethanol concentration was 0.033 g/dl according to Widmark formula and 0.02 g/dl according to breathalyzer results. Although overall incidence of symptoms was higher in the study group, the difference was not statistically significant (33% vs. 25%; p = 0.53). Conclusions These findings prove there is no difference in the onset of ethanol related symptoms when using CSI instead of lyophilized powder on the reconstitution of gemcitabine.

61.º Congreso de la SEFH. Saturnismo por tratamiento con medicina ayurvédica / No disponible

No disponible

Utility of day 8 blood tests on platinum plus vinorelbine regimen.

Background The combination of cisplatin or carboplatin with vinorelbine is one of the standard regimens in non-small-cell lung cancer. Some studies have shown that the hemogram on day-8 could be avoided in patients with cisplatin. However, carboplatin had not been studied and is considered to be more myelotoxic than cisplatin. Objective To quantify the incidence of thrombocytopenia, anemia, neutropenia and impaired liver and renal tests on day 8 in patients receiving a doublet protocol including a platinum and vinorelbine. Method The incidence of blood test abnormalities has been quantified in all patients who had received at least one course of cisplatin or carboplatin plus vinorelbine from January 14-December 14. Results Eighty-nine patients and 314 courses on day-8 were evaluated. Moderate or severe hematological toxicity was observed in 5.7 % courses. Dose was skipped in 1.3 % courses related to neutropenia. Renal and liver impairment were not shown. Delayed and reduced doses and early discontinued treatment on day-8 were not caused by blood test abnormalities. Conclusions Blood tests might be spared on day-8 depending on the individual characteristics, above all in patients with carboplatin.