A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip
Authors' conclusion
In a difficult-to-treat population with OA, fasinumab 1 mg Q4W achieved clinically meaningful improvements by week 16 versus placebo and naproxen. The safety profile was similar to that previously observed for fasinumab.
Study context
- Population
- Patients with difficult-to-treat osteoarthritis (OA) and moderate-to-severe pain due to OA of the knee or hip1,801 analysed for efficacy
- Participants
- 3,307 patients
- Comparison
- Fasinumab 1 mg subcutaneous (SC) Q4W or Q8W vs placebo and naproxen
- Primary endpoint
- Co-primary: change in WOMAC pain and physical function subscale scores (0-10) from baseline, fasinumab vs placebo
- Follow-up
- Week 16
Methodological detailsphase III, double-blind, multi-dose, placebo- and naproxen-controlled
- Phase III
- Double-blind
- Multi-dose
- Placebo- and naproxen-controlled
Primary result
As reported in the abstract
Change in WOMAC pain score (0-10)
Fasinumab 1 mg Q4W
−2.90
Placebo
−2.32
All p<0.005
Secondary outcomes
| Outcome | Fasinumab 1 mg Q4W | Naproxen | Placebo | P value |
|---|---|---|---|---|
| Co-primary: change in WOMAC physical function score (0-10) · week 16Fasinumab 1 mg Q4W vs Placebo · statistically significantly greater reduction | −2.78 | — not stated in the abstract | −2.10 | all p<0.005 |
| Change in WOMAC pain and physical function scores vs naproxen (secondary endpoint) · week 16 | −2.61 | all p<0.005 | ||
| WOMAC physical function change | — not stated in the abstract | −2.41 | — not stated in the abstract |
— not stated in the abstract
- Change in WOMAC pain and physical function scores vs naproxen (secondary endpoint): statistically significantly greater reductions in pain and physical function
- Change in WOMAC pain and physical function scores vs naproxen (secondary endpoint): Naproxen value = WOMAC pain change; measure = physical function change
Safety
Patients with adjudicated arthropathies
Patients with joint replacements
- Patients with adjudicated arthropathies — adjudicated arthropathies (AAs) that were rapid-progressive OA type 1, 1 mg Q8W
- 95.0%
- Patients with adjudicated arthropathies — AAs that were rapid-progressive OA type 1, 1 mg Q4W
- 75.5%
- Patients with adjudicated arthropathies: 3014 in safety analysis
New safety concerns
- No new safety concerns were identified
Original publication
A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip. RMD Open. Published 16 January 2026. doi:10.
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