adalimumab (9MW0113 / UBP 1211 / UBP1211)

An observational cohort study evaluating adalimumab concentrations for predicting non-recapture of biochemical response after dose escalation in patients with Crohn's disease experiencing secondary loss of response.

De Marco Davide D, McHugh Kevin K, Plamondon Sophie S, Rioux Louis-Charles LC et al.

There is limited evidence to support optimal concentrations for therapeutic drug monitoring in patients with Crohn's disease (CD) who experience a loss of response (LOR) to tumour necrosis factor antagonists. This study aimed to determine the threshold trough adalimumab concentration beyond which patients with LOR are unable to recapture a response after dose escalation. Enrolled patients had responded to adalimumab therapy after ≥16 weeks and subsequently experienced a secondary LOR, defined as a C-reactive protein (CRP) level ≥5 mg/L and/or a fecal calprotectin (FC) level ≥250 µg/g. Dosing was escalated from biweekly to weekly. Patients were then assessed for 12 weeks to determine their ability to recapture a response, defined as a CRP response (≥50% CRP decrease and/or CRP <5 mg/L) and/or FC response (≥50% FC decrease and/or FC <150 µg/g). The relationship between baseline trough concentration and non-recapture of biochemical response was evaluated using logistic regression. Of 97 enrolled patients, 49 (50.5%) did not recapture a response to adalimumab after dose escalation. Baseline trough concentration was not associated with non-recapture of biochemical response (odds ratio, 0.98; 95% CI: 0.91-1.06; P = .626). There was no threshold trough concentration identified that was predictive of non-recapture of biochemical response. No new adalimumab safety signals were identified. No association was observed between trough adalimumab concentration and non-recapture of biochemical response after dose escalation for secondary LOR in CD. The threshold concentration above which dose escalation is ineffective remains unclear. ClinicalTrials.gov identifier: NCT02896985.

Comparative efficacy and safety of tofacitinib versus adalimumab in patients with Behçet's uveitis: a real-world retrospective study.

Shu Qinmeng Q, Ding Xinyi X, Lei Boya B, Gu Ruiping R et al.

To conduct a comparative analysis of the efficacy and safety profiles of Tofacitinib (Tofa) and Adalimumab (ADA) in individuals diagnosed with refractory Behçet's uveitis. A retrospective analysis was conducted on the medical records of 64 patients who received Tofa (n = 30) or ADA (n = 34) in routine clinical practice. Treatment allocation was not randomized. The analysis focused on drug response rate, central macular thickness, ocular inflammation parameters, and best-corrected visual acuity at 3, 6, 12, and 24 months after treatment initiation. A total of 23 patients in the Tofa group (76.6%) and 24 patients in the ADA group (70.5%) achieved remission. Both groups exhibited improvements in mean best-corrected visual acuity (BCVA, Snellen chart, from baseline 0.33 ± 0.31 to 0.54 ± 0.27 in the ADA group, and from baseline 0.31 ± 0.27 to 0.57 ± 0.31 in the Tofa group), central macular thickness (CMT, from baseline 354.53 ± 101 μm to 199.71 ± 57 μm in the ADA group and from baseline 366.77 ± 120 μm to 203.67 ± 71 μm in the Tofa group), anterior chamber cell counts, and vitreous haze. No statistically significant differences were observed between the two groups in these overall outcomes. In an exploratory subgroup analysis, Tofa showed a lower response rate in patients with central occlusive retinal vasculitis, with 1/7 patients responding, whereas 6/8 patients responded in the ADA group (P = 0.041). Both ADA and Tofa demonstrated favorable efficacy in treating refractory Behçet's uveitis in this retrospective real-world study. The observed differences according to vasculitis phenotype should be interpreted cautiously and require confirmation in larger prospective studies.

JAAD Game Changers: "Adalimumab in conjunction with surgery compared with adalimumab monotherapy for hidradenitis suppurativa: A Randomized Controlled Trial in a real-world setting".

Brodell Robert T RT

Once yearly cell-based therapy for sustained and dose tunable delivery of monoclonal antibodies.

Fell Cody C, Davis Anthony E AE, Pandey Shalini S, Guinn Michael T MT et al.

Over 200 monoclonal antibodies (mAbs) are approved for clinical use, yet their therapeutic potential is constrained by dependence on repeated injections or infusions that drive non-adherence, limit access in low-resource settings, and generate peak-trough pharmacokinetics linked to adverse effects and reduced efficacy. Here, we developed an immunomodulatory encapsulated cell-based 'biologics factory' that overcomes mAb instability, immunogenicity, and the fibrotic foreign body response that have limited previous approaches, enabling continuous in situ production of therapeutic antibodies from a single administration. Screening chemically modified alginate biomaterials in immunocompetent mice identified a lead immunomodulatory alginate formulation that sustains stable serum titers of the HIV-neutralizing mAb 3BNC117 for one year. Single-cell RNA sequencing revealed that this formulation promotes a local anti-inflammatory, pro-resolving immune niche that attenuates fibrosis. The platform's versatility was demonstrated by production of thirteen diverse mAbs from an allogeneic cell chassis, with sustained in vivo delivery of a subset including ipilimumab, pembrolizumab, adalimumab, and PGT121. Integration into a retrievable macrodevice enabled on-demand therapeutic termination and re-implantation for dose-proportional tuning. In a non-human primates, subcutaneous implantation maintained stable ipilimumab titers for over six months with no detectable toxicity, anti-drug antibodies, or adverse events, and dose-dependent exposure was confirmed across a three-dose escalation. These results demonstrate a clinically translatable platform offering a practical strategy to replace frequent injections with single-administration therapy.