Phase Ib, multicentre, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered mosunetuzumab in participants with systemic lupus erythematosus.

What was studied

Mosunetuzumab is a drug that links T cells to B cells. This phase 1b study tested it in lupus (SLE). It was open-label and had many centers. It gave the drug as an injection under the skin. 15 people with active disease took part. Doses went up step by step. The first doses were 1.6 mg or 5 mg. Later step-up doses reached 15, 45 or 60 mg. The main goal was safety.

What they found

The people joined from January 2022 to December 2023. 2 people stopped the drug because of side effects. No serious nerve effects were reported. No high-grade cytokine release was reported. Severe side effects were uncommon. The drug lowered B cells in the blood in a dose-dependent way. T cells became active at all doses. Lupus scores improved. This was clearest in people with high scores at the start. It was also clear in people on higher doses.

What it means for patients

The team says the drug lowered B cells in a dose-linked way. Its safety profile was like earlier studies in follicular lymphoma. A phase 2 study in severe lupus is now under way.

Why it is not certain yet

Only 15 people took part. There was no comparison group. The study was built to test safety, not benefit. Score changes in this setting cannot show that the drug works.

Source

Phase Ib, multicentre, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered mosunetuzumab in participants with systemic lupus erythematosus.

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