Indirect comparison of biological treatments in refractory rheumatoid arthritis.

WHAT IS KNOWN AND OBJECTIVE: A number of biological treatments are available for rheumatoid arthritis. They are effective some patients but their comparative efficacy is inadequately evaluated. Our aim was to compare the efficacy of adalimumab, etanercept, infliximab, abatacept, tocilizumab, golimumab and certolizumab pegol in rheumatoid arthritis, refractory to disease-modifying antirheumatic drugs (DMARDs), through a systematic review of published trials. METHODS: As there were no direct comparisons, we searched for studies with similar characteristics to identify trials with results suitable for indirect comparison. Randomized, placebo-controlled pivotal clinical trials, with reported American College of Rheumatology ACR50 data at 24/30 weeks as efficacy endpoint, approved clinical doses and patients resistant to DMARDs who had not previously received other biological treatments were included. ACR50 was defined as the primary endpoint for the indirect comparison, with ACR20 and ACR70 as secondary endpoints. When two or more trials on one same drug were available, and a combined analysis was performed when appropriate. In the indirect comparison, the Bucher adjusted method was used with etanercept as reference drug. In the equivalence study, the equivalence window was a response efficacy difference of 15% between the alternatives. RESULTS AND DISCUSSION: Ten trials were found suitable for detailed analysis. In the clinical trials, all the biological drugs were seen to be more effective than placebo. Indirect comparison based on the ACR50 efficacy criterion all biological treatments showed similar results within the defined equivalence Δ value. The absolute efficacy difference (reduction of absolute risk, RAR) versus etanercept being 2·6% with adalimumab, 14% with infliximab, 11·6% with abatacept, 3% with tocilizumab, 12·4% with golimumab and 6·5% with certolizumab pegol. WHAT IS NEW AND CONCLUSION: The biological drugs used in rheumatoid arthritis are no different in efficacy. Their therapeutic positioning depends on their relative safety and convenience profiles.

[Erythropoietin: a study of its use in oncohematology]. / Eritropoyetina: estudio de utilización en oncohematología.

OBJECTIVE: To assess the effectiveness of erythropoietin (EPO) in a Clinical Oncohematology Unit within a general hospital, and to propose a therapeutic algorithm with EPO based on recommendations by ASCO. MATERIAL AND METHODS: A descriptive, retrospective study was carried out on patients who required support treatment with EPO while in the Oncohematology Unit during the year 2001. Data were collected by reviewing patient medical records. An effective treatment was defined as an increase in baseline hemoglobin (Hb) equal to or higher than 2 g/dL over 4-8 weeks, with no transfusion requirements or decreased transfusion needs. Baseline Hb values, their distribution per diagnosis, and the involvement of platinum-containing chemotherapy regimens were analyzed. RESULTS: Of the 353 patients in chemotherapy, 87% corresponded to oncologic diagnoses while the rest had hematological neoplasms. A total of 54 patients were assessed, with 83% of these corresponding to the oncologic area. Oncologic diagnoses that most required the use of EPO included: head-neck 53%, genitourinary 39%, and lung 39%. Overall effectiveness was 57% (60% in oncology and 44% in hematology). The Hb value leading to initial prescription (baseline Hb) was always below 10 g/dL for the hematology area, whereas most oncology patients exhibited higher levels at therapy onset. CONCLUSIONS: 1. Its percentage of failure: 40% for oncology and 56% for hematology patients, together with its high cost, shows that a further search for predictive factors is warranted in order to more precisely select individuals who may benefit from this therapy. 2. The percentage of oncology patients with baseline Hb <10 is only 29%. Baseline Hb values for treatment onset and peak Hb values for therapy discontinuation should be agreed upon. Treatment initiation when Hb values fall below 10 g/dL would be a reasonable option, and a decision to use EPO above 10 g/dL should be made in patients with less severe anemia (10-12 g/dL) only if clinical circumstances render it advisable. 3. Use protocols must include clear concept definitions for treatment, and for primary and secondary prophylaxis, which will help in the establishment of therapeutic algorithms.