Fasinumab for osteoarthritis: a systematic review and meta-analysis of efficacy and safety.
7 affiliations
- 1Department of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
- 2Liaquat University of Medical and Health Sciences, Jamshoro, Pakistan.
- 3UC Davis Health, Sacramento, California, U.S.A.
- 4Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, Ohio, U.S.A.
- 5Department of Orthopaedic Surgery, Dow University of Health Sciences, Karachi, Pakistan.
- 6Department of Internal Medicine, University of Florida (UF Health), UF Spanish Plaines Hospital, The Villages, FL, USA. [email protected].
- 7AdventHealth Sebring, Sebring, FL, USA. [email protected].
Abstract
Objective
Fasinumab, a newly developed anti-nerve growth factor monoclonal antibody, has been evaluated in clinical trials for its potential to alleviate symptoms in osteoarthritis patients. This meta-analysis evaluates the efficacy and safety of different Fasinumab dosages compared with placebo in patients with osteoarthritis.Methods
PubMed (MEDLINE), Cochrane CENTRAL, ClinicalTrials.gov, and Google Scholar were searched for double-blinded RCTs comparing Fasinumab with placebo till December 2025. Primary outcomes were WOMAC pain, WOMAC function, and Patient Global Assessment (PGA) scores. Secondary outcomes included safety profile such as Adjudicated Arthropathy, Adverse events, serious adverse events, all-cause mortality. Cochrane Risk of Bias 2 was used for quality assessment. A random effects model was used for analysis, with subgrouping by dosage.Results
Six RCTs, involving 9,429 participants, were included. All trials included had a low risk of bias. At 16 weeks, 1 mg Subcutaneous (SC) Every four weeks (Q4W), 1 mg SC Every eight weeks (Q8W), and 3 mg SC Q4W showed a greater statistically significant reduction in WOMAC pain and function scores compared to placebo. However, according to minimal clinically important differences (MCIDs), only 1 mg SC Q4W and 3 mg SC Q4W may provide clinically meaningful reductions in WOMAC pain ([MD: -1.05, (95% C.I. -1.32 to -0.78), p < 0.00001, I²=28%] and [MD: -1.16, (95% C.I. -1.58 to -0.75), p < 0.00001, I²=0%], respectively) and function scores ([-1.05 (95% C.I. -1.32 to -0.79), p < 0.00001, I²=20%] and [MD: -1.24, (95% C.I. -1.65 to -0.83), p < 0.00001, I²=0%], respectively) more than placebo; however, the confidence intervals include effects smaller than the MCID threshold, limiting certainty regarding clinically meaningful benefit. A 1 mg SC Q4W dosage regimen is favored over a placebo in improving PGA scores at 16 weeks. Further, Fasinumab use may increase the risk of adverse events, including Joint-replacement surgery and Adjudicated Arthropathy.Conclusion
Although select fasinumab regimens demonstrated statistically significant reductions in WOMAC pain, function, and PGA scores at 16 weeks, confidence interval overlaps with conservative MCID thresholds limit certainty regarding clinically meaningful efficacy. Additionally, treatment may carry increased risks, including adjudicated arthropathy.In addition, osteoarthritis is a chronic disease, and these short-term efficacy outcomes may not reflect long-term treatment effectiveness. These findings are based on trials assessed as having an overall low risk of bias. Further research is needed to confirm these findings.
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BibTeX
@article{khan2026fasinumab,
title = {{Fasinumab for osteoarthritis: a systematic review and meta-analysis of efficacy and safety.}},
author = {Muhammad Sohaib Khan and Wania Moeen and Umm E Salma Shabbar Banatwala and Muhammad Usman and Umar Mahmood and Syed Ashad Ahmed Fatmi and Syed Muhammad Muneeb Akhtar and Ashir Kanwal and Hania Shahzad and Muhammad Talal Ibrahim and Badaruddin Sahito and Muhammad Sohaib Asghar},
journal = {BMC musculoskeletal disorders},
year = {2026},
month = jul,
doi = {10.1186/s12891-026-10271-8},
url = {https://europepmc.org/article/MED/42902285},
note = {CC BY},
}
RIS
TY - JOUR
TI - Fasinumab for osteoarthritis: a systematic review and meta-analysis of efficacy and safety.
AU - Muhammad Sohaib Khan
AU - Wania Moeen
AU - Umm E Salma Shabbar Banatwala
AU - Muhammad Usman
AU - Umar Mahmood
AU - Syed Ashad Ahmed Fatmi
AU - Syed Muhammad Muneeb Akhtar
AU - Ashir Kanwal
AU - Hania Shahzad
AU - Muhammad Talal Ibrahim
AU - Badaruddin Sahito
AU - Muhammad Sohaib Asghar
PY - 2026
DA - 2026/07/01
JO - BMC musculoskeletal disorders
DO - 10.1186/s12891-026-10271-8
UR - https://europepmc.org/article/MED/42902285
AB - Objective Fasinumab, a newly developed anti-nerve growth factor monoclonal antibody, has been evaluated in clinical trials for its potential to alleviate symptoms in osteoarthritis patients. This meta-analysis evaluates the efficacy and safety of different Fasinumab dosages compared with placebo in patients with osteoarthritis.Methods PubMed (MEDLINE), Cochrane CENTRAL, ClinicalTrials.gov, and Google Scholar were searched for double-blinded RCTs comparing Fasinumab with placebo till December 2025. Primary outcomes were WOMAC pain, WOMAC function, and Patient Global Assessment (PGA) scores. Secondary outcomes included safety profile such as Adjudicated Arthropathy, Adverse events, serious adverse events, all-cause mortality. Cochrane Risk of Bias 2 was used for quality assessment. A random effects model was used for analysis, with subgrouping by dosage.Results Six RCTs, involving 9,429 participants, were included. All trials included had a low risk of bias. At 16 weeks, 1 mg Subcutaneous (SC) Every four weeks (Q4W), 1 mg SC Every eight weeks (Q8W), and 3 mg SC Q4W showed a greater statistically significant reduction in WOMAC pain and function scores compared to placebo. However, according to minimal clinically important differences (MCIDs), only 1 mg SC Q4W and 3 mg SC Q4W may provide clinically meaningful reductions in WOMAC pain ([MD: -1.05, (95% C.I. -1.32 to -0.78), p < 0.00001, I²=28%] and [MD: -1.16, (95% C.I. -1.58 to -0.75), p < 0.00001, I²=0%], respectively) and function scores ([-1.05 (95% C.I. -1.32 to -0.79), p < 0.00001, I²=20%] and [MD: -1.24, (95% C.I. -1.65 to -0.83), p < 0.00001, I²=0%], respectively) more than placebo; however, the confidence intervals include effects smaller than the MCID threshold, limiting certainty regarding clinically meaningful benefit. A 1 mg SC Q4W dosage regimen is favored over a placebo in improving PGA scores at 16 weeks. Further, Fasinumab use may increase the risk of adverse events, including Joint-replacement surgery and Adjudicated Arthropathy.Conclusion Although select fasinumab regimens demonstrated statistically significant reductions in WOMAC pain, function, and PGA scores at 16 weeks, confidence interval overlaps with conservative MCID thresholds limit certainty regarding clinically meaningful efficacy. Additionally, treatment may carry increased risks, including adjudicated arthropathy.In addition, osteoarthritis is a chronic disease, and these short-term efficacy outcomes may not reflect long-term treatment effectiveness. These findings are based on trials assessed as having an overall low risk of bias. Further research is needed to confirm these findings.
SN - 1471-2474
ER -