Objective To systematically review the efficacy and safety of denosumab in the treatment of rheumatoid arthritis. Methods The PubMed, EMbase, Web of Science, The Cochrane Library, CNKI, WanFang Data, and VIP databases were searched to collect randomized controlled trials (RCTs) of denosumab in the treatment of rheumatoid arthritis. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.4 software. Results A total of 7 RCTs including 2 346 patients were included. The results of meta-analysis showed that administering 60 mg densuzumab every 6 months (Q6M) was superior to placebo in increasing the bone mineral density (BMD) of the lumbar spine, the hip, the femoral neck, and improving the modified total Sharp score. Administering 60 mg denosumab every 3 months (Q3M) and 60 mg Q6M were both superior to the placebo group at improving erosion score; in addition, the 60 mg Q3M group was superior to the 60 mg Q6M group. There was no significant difference between denosumab and the placebo in improving joint space narrowing score, the American College of Rheumatology 20%, 50%, or 70% responses, health assessment questionnaire disability index, or disease activity score. In terms of safety, there was no significant difference between denosumab and the placebo group. Conclusion Densuzumab can delay the progression of rheumatoid arthritis bone erosion, and its safety is acceptable. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.
Objective With the increasing clinical application of biologics in osteoporosis treatment, challenges such as insufficient evidence for rational drug use and a lack of evidence-based guidance have emerged in clinical practice. To address these issues, the Committee of Evidence-Based Pharmacy of Chinese Pharmaceutical Association, the Pharmaceutical Specialized Committee of Chinese Hospital Association and the Committee of Osteoporosis of Beijing Research Association for Chronic Diseases Control and Health Education jointly developed the medication therapy of biological agents in osteoporosis: an evidence-based practice guideline (2025). It aims to standardize the medication therapy of osteoporosis biologics (Denosumab and Teriparatide). Methods The design, planning, development process, and reporting of this guideline adhered to international methodological standards, such as the WHO handbook for guideline development. We integrated the three core principles of evidence-based medicine: systematic evidence analysis using evidence-based pharmacy methods, evidence quality assessment via the GRADE framework, incorporation of patient preferences through surveys, and consolidation of multidisciplinary expert clinical experience via the Delphi method. This guideline was registered on the International Practice Guidelines Registry Platform (Registration No. IPGRP-2022CN386), with development initiated in July 2022 and finalized in October 2025. Results This guideline established a decision-making framework comprising 28 recommendations, covering the entire pharmaceutical care process for Denosumab and Teriparatide in osteoporosis treatment: pre-treatment assessment (9 recommendations), formulation of treatment protocol (11 recommendations), monitoring and management during treatment (6 recommendations), and sequential therapy after discontinuation (2 recommendations). Conclusion As the first clinical practice guideline for osteoporosis biologics developed based on the integration of evidence, experts’ clinical experience, and patient preferences, it proposes an innovative pharmaceutical care strategy (assessment-treatment-monitoring-sequential therapy). Multidisciplinary clinical teams may refer to this guideline to deliver pharmaceutical services and patient management throughout the pre-treatment, during-treatment, and post-treatment phases of Denosumab and Teriparatide therapy for osteoporosis patients.