Adalimumab biosimilars: real-world and switching evidence

Pharmacokinetic similarity demonstrated between the switching and continued-use groups for AUCtau and Cmax at weeks 28 to 30; adherence, completion and discontinuation similar between groups.

AUCtau, Cmax and Cmin for weeks 26 to 28 within 80 to 125%; PASI responses and sPGA success highly similar at week 28; safety and immunogenicity comparable. FDA interchangeability granted.

AUCtau and Cmax ratios for weeks 25 to 27 of 99.45% and 100.45%, 90% CIs within 80 to 125%; efficacy, safety and immunogenicity similar between groups.

Efficacy maintained (mean PASI improvement from baseline 90.34% at week 52); safety similar between prior groups; immunogenicity did not increase during the extension.

AUCtau and Cmax ratios for weeks 26 to 28 within 80 to 125%; PASI, DLQI and sPGA similar; no clinically meaningful differences in immunogenicity or safety.

Pharmacokinetics equivalent between switching and continuous arms; efficacy, immunogenicity and safety highly similar.

PASI similar between switched and continued groups from week 17 to 51; no relevant safety or immunogenicity differences; no hypersensitivity reported on switching.

Efficacy, pharmacokinetics, safety and immunogenicity similar across groups from week 26 to 52; anti-drug antibody positive at week 52 in 28.3% switched, 28.4% continued CT-P17 and 27.0% continued reference; no adverse effect of a single switch.

ACR20 at week 52 88.4%, 88.2% and 87.6% for continuous biosimilar, week 26 switch and week 52 switch; responses sustained and comparable through week 78; treatment-emergent adverse events in 42.6%, 37.0% and 50.8%; anti-drug antibodies in 46.1%, 46.5% and 54.2%.

Anti-drug antibody positivity similar for FKB327 and reference at all time points and did not increase across switching sequences.

ACR20 83.2% to 85.9% at extension week 30 and stable through week 76 regardless of single or double switching; safety and anti-drug antibody incidence comparable across sequences.

Transition from reference to ABP 501 did not affect efficacy, safety or immunogenicity; ACR20 and DAS28-CRP maintained.

Change in DAS28-ESR and ACR20/50/70 similar across switched and continuous groups to week 48; immunogenicity and safety similar; switch had no impact on efficacy, safety or immunogenicity.

ACR20/50/70 responses at week 24 maintained after transition and comparable across groups; ACR20 73.4% to 78.8% at week 52; safety and anti-drug antibody incidence comparable.

Sustained clinical remission in 95.4% of the multi-switch group and 93.6% of the single-switch group; sustained normal inflammatory markers in 91.5% and 92.3%; no treatment-emergent adverse events, infections or discontinuations in either group.

Drug survival hazard ratio 1.11 (95% CI 0.58 to 2.12) for SB5 with GP2017 as reference; no differences in PASI change at 120 days.

Total healthcare costs, mainly hospital costs, were largely similar or decreased after the switch; results similar for GP2017 and SB5.

No significant change in clinical activity or faecal calprotectin at 6 months in either the ABP 501 or the SB5 group; 8 patients in the ABP 501 group needed added steroids; 14.5% stopped therapy by 6 months.

70.8% of the switch cohort remained on SB5 beyond one year; 90 of 256 discontinued, mainly for adverse events (46) or secondary loss of response (37); no differences in clinical remission, CRP, faecal calprotectin or trough levels between baseline, week 26 and week 52; injection-site pain the most frequent adverse event.

A non-medical switch from originator to biosimilar adalimumab was not associated with a change in 1-year drug retention.

Combined 1-year retention 89.5%; withdrawal 8.5% on GP2017 and 12.9% on SB5 (HR 0.60 for GP2017); 6-month remission higher with GP2017 (OR 1.72); 3.6% back-switched to originator.

88.5% (54 of 61) remained on SB5 at 6 months; switch success (no systemic steroids, no discontinuation, no dose escalation) in 82.0% (50 of 61); CRP above 5 mg/L predicted switch failure; side effects in 7 patients (11.5%) against 1 (1.6%) in the six months before the switch.

No difference in disease activity, CRP or faecal calprotectin between week 0 and week 10 in either cohort; adalimumab trough levels stable after the switch; no new safety signals.