medwireNews: Extended phase 2b follow-up data show that ianalumab is well tolerated for at least 1 year in people with primary Sjögren’s syndrome (pSS), and prolonging treatment beyond 6 months leads to further improvements in efficacy outcomes.
The findings, presented by Simon Bowman, from the University of Birmingham in the UK, at the ACR Convergence 2021 virtual meeting add to the key primary results from week 24, which showed that ianalumab elicits a statistically significant dose-response in EULAR Sjögren’s Syndrome Disease Activity index (ESSDAI), with clinically important improvements at the highest dose versus placebo.
For the study, 190 patients were randomly assigned to receive subcutaneous ianalumab 5 mg, 50 mg, or 300 mg, or placebo every 4 weeks for 24 weeks. Placebo-treated patients (n=47) were then switched to ianalumab 150 mg, and patients receiving ianalumab 300 mg were re-randomized to continue at that dose (n=21) or switch to placebo for a further 28 weeks (n=22). Individuals receiving ianalumab 5 mg (n=47) and 50 mg (n=47) went straight to follow-up.
Bowman reported that, at 52 weeks, individuals who switched from placebo to ianalumab 150 mg experienced improvements in ESSDAI, EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI), Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F), Physician’s (PhGA) and Patient’s Global Assessments (PaGA), 36-Item Short Form Survey (SF-36), and SS symptom diary (SSSD).
Individuals who remained on ianalumab 300 mg also experienced improvements between weeks 24 and 52 in all outcomes but pain, with particular gains noted for PhGA and PaGA.
Conversely, eight of the 11 outcomes measured worsened in people who switched from ianalumab 300 mg to placebo, with the greatest decline recorded for PaGA.
Since ianalumab is a fully human monoclonal antibody blocking B-cell activating factor receptor, that is additionally engineered for direct ADCC-mediated B-cell depletion, Bowman and team measured median time to CD19+ B-cell recovery after stopping treatment and found that this was generally dose proportional. Recovery ranged from a median of 3.8 months for the people who received ianalumab 5 mg for 24 weeks to 8.4 months for those who received 300 mg for 24 weeks. The median B-cell recovery time was 6.5 months in the group that received ianalumab 300 mg for 52 weeks.
Bowman said that these recovery times are “broadly similar” to those seen for other B-cell depleting agents such as rituximab.
He also reported that “ianalumab was well-tolerated up to week 52” and treatment-emergent adverse events (TEAEs) were not dose-dependent, with the exception of local injection site reactions.
The most common TEAEs were infections, typically nasopharyngitis and upper respiratory tract infections.
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