Recommendations by the Spanish Society of Rheumatology on risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis.

OBJECTIVE: To present recommendations based on the available evidence and the consensus of experts, for risk management of biological treatment and JAK inhibitors in patients with rheumatoid arthritis. METHODS: Clinical research questions relevant to the purpose of the document were identified. These questions were reformulated in PICO format (patient, intervention, comparison, outcome or outcome) by a panel of experts, selected based on their experience in the area. A systematic review of the evidence was carried out, grading according to the GRADE criteria (Grading of Recommendations Assessment, Development, and Evaluation). Specific recommendations were then formulated. RESULTS: 6 PICO questions were proposed by the panel of experts based on their clinical relevance and the existence of recent information regarding the risk of occurrence of serious infections, the risk of reactivation of the hepatitis B virus, the risk of reactivation of the virus varicella-zoster, the risk of appearance of skin (melanoma and non-melanoma) or haematological cancer, the risk of appearance of thromboembolic disease and the risk of progression of the human papilloma virus. A total of 28 recommendations were formulated, structured by question, based on the evidence found and the consensus of the experts. CONCLUSIONS: The SER recommendations on risk management of treatment with biologic therapies and JAK inhibitors in rheumatoid arthritis are presented.

Postlaunch evidence generation practices among health technology assessment bodies in Europe.

OBJECTIVES: The term Postlaunch Evidence Generation (PLEG) refers to evidence generated after the launch or licensing of a health technology. The aim of this paper is to provide an overview of the implementation of these practices in the European Union in order to explore cross-border cooperation opportunities. METHODS: In December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to all twenty-five dedicated work package (WP5B) partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3. In addition to the survey, the national practices were discussed during a face-to-face meeting with WP5B partners. RESULTS: Twelve Health TechnologyAssessment (HTA) bodies completed the survey. Of these, eleven reported procedures in place for official requests for PLEGs in their remit. In the large majority of cases, the requests are made at the time of the assessment/appraisal. Several agencies participate in the definition of the scope of the PLEG or review of its protocol. Data collection and analysis mainly lie with companies for pharmaceuticals, whereas it is more the responsibility of the HTA bodies for medical devices. Only one agency owns the data and is able to exchange them without asking permission. CONCLUSIONS: Most agencies recommend European collaboration on PLEG commence once the evidence gaps have been defined or during the production of the HTA report in the case of European joint assessment.

Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.

Safety and Efficacy of Mechanical Thrombectomy Using Stent Retrievers in the Endovascular Treatment of Acute Ischaemic Stroke: A Systematic Review.

BACKGROUND: The treatment of choice for acute ischaemic stroke is the intravenous administration of recombinant tissue plasminogen activator within 3-4.5 h of symptom onset. However, the use of a thrombolytic would be limited by its narrow therapeutic window and contraindications. As a result, in recent years, techniques such as mechanical thrombectomy have emerged, which employ thrombus retrieval devices, such as stent retrievers (Solitaire™, Trevo® or Revive™), whose safety and efficacy in the endovascular treatment of acute ischaemic stroke is analysed in this article. METHODS: A systematic literature search was undertaken until March 2015. The quality of evidence was assessed according to the GRADE methodology. A meta-analysis of the results of randomised controlled trials (RCTs) was performed, and the weighted average for the case series' sample size was calculated (Review Manager v5.2 and SPSS v19). RESULTS: Seventeen primary studies (2 RCTs, Solitaire™ and Trevo® vs. Merci®, and 15 case series) were selected. The RCT results show that stent retrievers have a safety profile similar to the Merci® device. However, both Solitaire™ and Trevo® achieved a higher recanalisation success rate (OR, 4.56; 95% CI, 2.63-7.90; p < 0.00001) and appropriate clinical outcome at 90 days (OR, 2.54; 95% CI, 1.52-4.25; p < 0.0004), although the 90-day mortality rate was similar in both groups (OR, 0.75; 95% CI, 0.17-3.37; p = 0.70). CONCLUSIONS: Stent retrievers appear to be safe and effective devices, achieving high recanalisation rates and good clinical outcomes in the endovascular treatment of patients with acute ischaemic stroke due to the occlusion of intracranial arteries in comparison with the clot retriever Merci®.