Uplizna (inebilizumab-cdon)

We summarize pivotal translational inflection points, from rituximab extension beyond lymphoma to approvals of ocrelizumab, ofatumumab, ublituximab, and inebilizumab in neuroimmunology. We further review plasma cell-directed and T-cell-engaging strategies for deep immune resets in refractory disease, while clarifying implications for trial design, long-term safety, and implementation. Finally, we introduce a model-informed roadmap integrating population PK/PD, exposure-response, and quantitative systems pharmacology to optimize indication selection, patient enrichment, and dose/regimen design-supporting confident extrapolation rather than empiricism.

P3, N=180, Not yet recruiting, Amgen

P3, N=238, Active, not recruiting, Amgen | Trial completion date: Nov 2027 --> Jun 2029

P2, N=15, Recruiting, Amgen | Initiation date: Apr 2026 --> Aug 2026

P2, N=220, Recruiting, Amgen | Trial completion date: Mar 2029 --> Jul 2028 | Trial primary completion date: Jan 2028 --> Jul 2028

P2, N=15, Not yet recruiting, Amgen | Initiation date: Apr 2026 --> Jul 2026

P2, N=15, Not yet recruiting, Amgen

P4, N=80, Completed, Affiliated Provincial Hospital of Shandong First Medical University (Shandong Provincial Hospital); Affiliated Provincial Hospital of Shandong First M

P4, N=540, Not yet recruiting, Massachusetts General Hospital | N=160 --> 540

P1/2, N=2, Not yet recruiting, Amgen Inc.

P2, N=220, Recruiting, Amgen | N=98 --> 220 | Trial completion date: Jun 2029 --> Mar 2029 | Trial primary completion date: Sep 2028 --> Jan 2028

Maintenance therapy with steroid-sparing immunomodulators (e.g., azathioprine, mycophenolate mofetil) or B-cell depleting agents such as rituximab is often required. The anti-CD19 monoclonal antibody inebilizumab has emerged as a potent new option for maintaining remission. Maintaining a high index of clinical suspicion for IgG4-SC is essential in patients with obstructive jaundice and biliary strictures. Future efforts should focus on validating specific biomarkers (e.g., circulating plasmablasts, autoantibody profiles) and developing evidence-based protocols for long-term management to prevent fibrotic complications and reduce the relapse rate.