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Anti-BAFF Monoclonal Antibody (B-Cell Survival Factor Inhibitor)

Ianalumab (Anti-BAFF — Primary Sjögren's Syndrome)

Brand names: VAY736 (investigational name — regulatory submission 2024)

Ianalumab is an investigational anti-BAFF receptor monoclonal antibody being studied for primary Sjögren's syndrome and other autoimmune conditions.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It targets the B-cell activating factor (BAFF) receptor, combining B-cell depletion through antibody-dependent cellular cytotoxicity with blockade of BAFF-mediated B-cell survival signalling.

Prescribing in practice

  • As a B-cell-depleting agent it is expected to increase infection risk, so infection screening and vigilance are appropriate within its trial and specialist setting.
  • It is used under specialist supervision, largely within clinical trials, as its place in therapy is still being defined.
  • Live vaccines would be expected to be avoided during B-cell-depleting treatment.

Monitoring

Monitoring focuses on infection, immunoglobulin levels and B-cell counts in line with B-cell-depleting therapy.

Counselling the patient

  • Report any signs of infection promptly.
  • Discuss vaccination, including avoidance of live vaccines, with the specialist team.
  • Attend all study or specialist follow-up appointments.

Evidence & guidelines

Activity in primary Sjögren's syndrome has been reported in randomised placebo-controlled phase II studies, with further trials ongoing.

Reference: Bowman et al. EULAR 2023 (TWINSS Phase 3); Nocturne et al. JAMA 2024; Novartis Regulatory Submission 2024; BSR Sjögren's Guidelines 2017; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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