Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study
Authors' conclusion
The risk of multiple switches between reference adalimumab and adalimumab-afzb with respect to diminished efficacy (using pharmacokinetics as a surrogate) or safety is not greater than the risk of using reference adalimumab alone.
Study context
- Population
- Patients aged 18–70 years with moderately to severely active RA on stable MTX, after 10 weeks of reference adalimumabrandomly assigned
- Participants
- 427 patients
- Comparison
- Three switches between reference adalimumab and adalimumab-afzb vs continuous reference adalimumab
- Switchingn = 213
- Non-switchingn = 214reference
- Primary endpoint
- Cmax and AUCτ (geometric mean ratios, 90% CIs within equivalence margins of 80-125%)
- Follow-up
- Weeks 30-32
Methodological detailsphase 3, open-label, parallel-group, multi-switch, equivalence margins 80-125%, multicentre (61 sites, ten countries)
- Phase 3
- Open-label
- Parallel-group
- Multi-switch
- Equivalence margins 80-125%
- Multicentre (61 sites, ten countries)
Primary result
As reported in the abstract
Steady-state PK, weeks 30-32 (PK population, n=380): AUCτ and Cmax
| Group | Value | Cmax (geometric mean, μg/mL) |
|---|---|---|
| Switching | geometric mean 2237 μg × h/mL | 8.21 |
| Non-switching | geometric mean 2125 μg × h/mL | 8.00 |
Value
Switchinggeometric mean 2237 μg × h/mL
Non-switchinggeometric mean 2125 μg × h/mL
Cmax (geometric mean, μg/mL)
Switching8.21
Non-switching8.00
- AUCτ geometric mean ratio, switching vs non-switching (90% CI 89.16-124.39), within prespecified equivalence margins
- 105.31
- Cmax geometric mean ratio, switching vs non-switching (90% CI 89.78-117.17), within prespecified equivalence margins
- 102.56
Further findings
- No deaths were reported
Safety
Serious adverse events
Discontinuations due to adverse events
Grade ≥3 adverse events of special interest; immunogenic reactions in antidrug antibody-positive patients
- No meaningful differences observed
Original publication
Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study. Lancet Rheumatol. Published 21 August 2023. doi:10.
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