Spondyloarthritis & psoriatic arthritis
The role of antidrug antibodies in ustekinumab therapy and the impact of methotrexate
Authors' conclusion
Concomitant MTX had no significant impact on UST immunogenicity. Furthermore, ADA formation was not associated with impairments in UST safety, efficacy or trough levels.
Study context
- Population
- Patients with PsA treated with ustekinumab (UST)
- Participants
- 112 serum samples
- Comparison
- UST plus concomitant MTX vs UST plus placebo
- UST/MTXn = 58
- UST/pbon = 54reference
- Primary endpoint
- ADA formation against UST
- Follow-up
- 52 weeks
Methodological detailspost-hoc analysis, randomized (1:1), double-blind, multicentre, open-label UST
- Post-hoc analysis
- Randomized (1:1)
- Double-blind
- Multicentre
- Open-label UST
Primary result
As reported in the abstract
Patients developing ADA · Over 52 weeks
UST/MTX
19
events
UST/pbo
11
events
P > 0.05
Further findings
| Outcome | P value |
|---|---|
| Visit-dependent UST levels, range | P > 0.05 |
- Visit-dependent UST levels, range — UST/pbo overall
- 0.047 (0.05) −0.110 (0.07) µg/ml
- Visit-dependent UST levels, range — UST/pbo antidrug antibody (ADA)-confirmed
- 0.037 (0.04)-0.091 (0.08) µg/ml
- Visit-dependent UST levels, range — UST/MTX overall
- 0.0502 (0.04)-0.106 (0.07) µg/ml
- Visit-dependent UST levels, range — UST/MTX ADA positive
- 0.029 (0.03)-0.097 (0.07) µg/ml
Clinical outcomes, ADA-confirmed vs ADA-negative · week 52
- No significant difference
- P > 0.05
Safety
Safety, ADA-confirmed vs ADA-negative · week 52
- No significant difference
- P > 0.05
Original publication
The role of antidrug antibodies in ustekinumab therapy and the impact of methotrexate. Rheumatology (Oxford). Published 20 April 2023. doi:10.
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