Browsing by Author "Malcata, A"
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- Health-related quality of life in portuguese SLE patients: an outcome measure independent of disease activity and cumulative damagePublication . Duarte, C; Abreu, P; Couto, M; Vaz, C; Malcata, A; Inês, LPURPOSE: To evaluate quality of life in Portuguese patients with Systemic Lupus Erithematosus (SLE) and its correlation with disease activity and cumulative damage. METHODS: We included consecutive SLE patients, fulfilling the 1997 ACR Classification Criteria for SLE and followed at the Rheumatology Department of the University Hospital of Coimbra, Portugal at time of visit to the outpatient clinic. Quality of life was evaluated using the patient self-assessment questionnaire Medical Outcomes Survey Short Form-36 (SF-36) (validated Portuguese version). The consulting rheumatologist fulfilled the SLE associated indexes for cumulative damage (Systemic Lupus International Collaborating Clinics- Damage Index: SLICC/ACR-DI) and disease activity (Systemic Lupus Erythematosus Disease Activity Index: SLEDAI 2000). Correlation between SLEDAI and SLICC and SF-36 was tested with the Spearman Coefficient. Significant level considered was 0.05. RESULTS: The study included 133 SLE patients (90.2% female, mean age - 40.7 years, mean disease duration - 8.7 years). Most patients presented low disease activity (mean SLEDAI = 4.23) and limited cumulative damage (mean SLICC = 0.76). Despite that, SF-36 mean scores were below 70% in all eight domains of the index. Physical function domains showed lower scores than mental function domains. The QoL in this group of patients is significantly impaired when compared with the reference Portuguese population (p<0.05 in all domains). There was no correlation between clinical activity or cumulative damage and quality of life. CONCLUSION: QoL is significantly compromised in this group of SLE patients, but not related with disease activity or damage. These findings suggest that disease activity, cumulative damage and QoL are independent outcome measures and should all be used to assess the full impact of disease in SLE patients.
- The Portuguese Society of Rheumatology position paper on the use of biosimilarsPublication . Fonseca, JE; Gonçalves, J; Araújo, F; Cordeiro, I; Teixeira, F; Canhão, H; Pereira da Silva, JA; Garcês, S; Miranda, LC; Ramiro, Sofia; Roxo, Ana; Pimentel-Santos, FM; Tavares, V; Neto, A; Sepriano, A; Malcata, A; Faustino, A; Silva, C; Ambrósio, C; Duarte, C; Miguel, C; Barcelos, F; Santos, H; Cunha, I; Ramos, JC; Melo-Gomes, JA; Pimentão, JB; Costa, L; Maurício, L; Silva, M; Bernardes, M; Bogas, M; Coelho, PC; Monteiro, P; Aguiar, R; André, R; Leitão, R; Pimenta, S; Meirinhos, T; Fernandes, S; Las, V; Castelão, WBiotechnological drugs have become a fundamental resource for the treatment of rheumatic patients. Patent expiry of some of these drugs created the opportunity for biopharmaceutical manufacturers to develop biosimilar drugs intended to be as efficacious as the originator product but with a lower cost to healthcare systems. Due to the complex manufacturing process and highly intricate structure of biologicals, a biosimilar can never be an exact copy of its reference product. Consequently, regulatory authorities issued strict preclinical and clinical guidelines to ensure safety and efficacy equivalence and, in September 2013, the biosimilar of infliximab was the first biosimilar monoclonal antibody to be authorized for use in the European Union. The current document is a position statement of the "Sociedade Portuguesa de Reumatologia" (Portuguese Society of Rheumatology) on the use of biosimilar drugs in rheumatic diseases. Two systematic literature reviews were performed, one concerning clinical trials and the other one concerning international position papers on biosimilars. The results were presented and discussed in a national meeting and a final position document was discussed, written and approved by Portuguese rheumatologists. Briefly, this position statement is contrary to automatic substitution of the originator by the biosimilar, defends either a different INN or the prescription by brand name, supports that switching between biosimilars and the originator molecule should be done after at least 6 months of treatment and based on the attending physician decision and after adequate patient information, recommends the registration of all biosimilar treated patients in Reuma.pt for efficacy, safety and immunogenicity surveillance, following the strategy already ongoing for originators, and opposes to extrapolation of indications approved to the originator to completely different diseases and/or age groups without adequate pre-clinical, safety or efficacy data.