Systematic Review and Meta-Analysis of the Efficacy and Safety of Biologics in the Treatment of Ankylosing Spondylitis
Author(s)
Hang Thuy Nguyen, Pharmacist1, Chi Thanh Quynh Tran, Pharmacist2, Thuy Thi Thu Nguyen, MBA, PhD3.
1Health Technology Assessment and Application Research Institute, Ho Chi Minh, Viet Nam, 2Hong Bang International University, Ho Chi Minh, Viet Nam, 3University of Medicine and Pharmacy at Ho Chi Minh city, Ho Chi Minh, Viet Nam.
1Health Technology Assessment and Application Research Institute, Ho Chi Minh, Viet Nam, 2Hong Bang International University, Ho Chi Minh, Viet Nam, 3University of Medicine and Pharmacy at Ho Chi Minh city, Ho Chi Minh, Viet Nam.
OBJECTIVES: This systematic review and meta-analysis (SR/MA) aims to evaluate the efficacy and safety of biologic agents in the treatment of ankylosing spondylitis (AS).
METHODS: The SR/MA was conducted following PRISMA guidelines with a comprehensive literature search conducted in PubMed and Cochrane databases using relevant keywords up to April 1, 2025. Studies were selected based on pre-defined inclusion and exclusion criteria, and study quality was assessed using the CONSORT checklist. Full data on study characteristics and outcomes related to the efficacy and safety of biologics in AS treatment were extracted.
RESULTS: A total of 544 records were initially identified, of which 26 studies were included: 17 studies on TNF-α-inhibitors (etanercept, infliximab, adalimumab, golimumab, certolizumab), 5 studies on IL-17-inhibitors (secukinumab, ixekizumab), and 4 studies on JAK-inhibitors (tofacitinib, upadacitinib). The efficacy results from SR/MA showed that all three classes of biologics outperformed placebo with significant improvements in BASDAI scores (mean differences after treatment: -1.75 [95%CI: -1.92; -1.58]; -1.24 [95%CI: -1.54; -0.93]; -0.64 [95%CI: -1.22; -0.05], respectively), ASAS20 response rates (ORs: 4.18 [95%CI: 3.60-4.87]; 2.52 [95%CI: 2.13-2.98]; 2.87 [95%CI: 2.22-3.71], respectively), and ASAS40 response rates (ORs: 5.16 [95%CI: 4.28-6.22]; 2.81 [95%CI: 2.21-3.41]; 3.56 [95%CI: 2.73-4.64], respectively). For safety outcomes, biologics showed no significant differences compared to placebo in mortality and serious adverse events (SAEs). However, results of adverse events (AEs) had differences: JAK-inhibitors showed no significant difference, while TNF-α and IL-17-inhibitors were associated with increasing AEs when compared to placebo (ORs: 1.74 [95%CI: 1.49-2.03] and 1.32 [95%CI: 1.12-1.56], respectively).
CONCLUSIONS: Biologics demonstrated significantly greater clinical efficacy compared to placebo in the treatment of AS, with consistent improvements in BASDAI, ASAS20, and ASAS40. While mortality and SAEs rates were similar across groups which had no significant differences compared to placebo, AEs risks varied by biologic class, being no significant different for JAK-inhibitors and increased for TNF-α and IL-17-inhibitors.
METHODS: The SR/MA was conducted following PRISMA guidelines with a comprehensive literature search conducted in PubMed and Cochrane databases using relevant keywords up to April 1, 2025. Studies were selected based on pre-defined inclusion and exclusion criteria, and study quality was assessed using the CONSORT checklist. Full data on study characteristics and outcomes related to the efficacy and safety of biologics in AS treatment were extracted.
RESULTS: A total of 544 records were initially identified, of which 26 studies were included: 17 studies on TNF-α-inhibitors (etanercept, infliximab, adalimumab, golimumab, certolizumab), 5 studies on IL-17-inhibitors (secukinumab, ixekizumab), and 4 studies on JAK-inhibitors (tofacitinib, upadacitinib). The efficacy results from SR/MA showed that all three classes of biologics outperformed placebo with significant improvements in BASDAI scores (mean differences after treatment: -1.75 [95%CI: -1.92; -1.58]; -1.24 [95%CI: -1.54; -0.93]; -0.64 [95%CI: -1.22; -0.05], respectively), ASAS20 response rates (ORs: 4.18 [95%CI: 3.60-4.87]; 2.52 [95%CI: 2.13-2.98]; 2.87 [95%CI: 2.22-3.71], respectively), and ASAS40 response rates (ORs: 5.16 [95%CI: 4.28-6.22]; 2.81 [95%CI: 2.21-3.41]; 3.56 [95%CI: 2.73-4.64], respectively). For safety outcomes, biologics showed no significant differences compared to placebo in mortality and serious adverse events (SAEs). However, results of adverse events (AEs) had differences: JAK-inhibitors showed no significant difference, while TNF-α and IL-17-inhibitors were associated with increasing AEs when compared to placebo (ORs: 1.74 [95%CI: 1.49-2.03] and 1.32 [95%CI: 1.12-1.56], respectively).
CONCLUSIONS: Biologics demonstrated significantly greater clinical efficacy compared to placebo in the treatment of AS, with consistent improvements in BASDAI, ASAS20, and ASAS40. While mortality and SAEs rates were similar across groups which had no significant differences compared to placebo, AEs risks varied by biologic class, being no significant different for JAK-inhibitors and increased for TNF-α and IL-17-inhibitors.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO229
Topic
Clinical Outcomes, Health Technology Assessment, Medical Technologies
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal), Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)