AbbVie has reported topline data from the Phase II SLEek trial of upadacitinib (RINVOQ, 30mg) in moderately to severely active systemic lupus erythematosus (SLE) patients.
The trial evaluated upadacitinib alone or as combination therapy (ABBV-599) with Bruton’s Tyrosine Kinase inhibitor (elsubrutinib, 60 mg) in SLE patients.
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In the trial, 341 participants were enrolled and subsequently divided into five experimental groups.
The findings showed that the trial met its primary endpoint of SLE Responder Index (SRI-4) and a steroid dose less than or equal to 10mg prednisone equivalent once-a-day at week 24 in the upadacitinib 30mg group.
For the upadacitinib 30mg group, the safety results were found to be consistent with the known safety profile of upadacitinib and no new safety signals were identified.
Similar adverse events were reported for patients treated with upadacitinib alone and those with upadacitinib along with elsubrutinib.
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By GlobalDataAbbVie chief medical officer and development and regulatory affairs senior vice-president Roopal Thakkar said: “Systemic lupus erythematosus is a very unpredictable life-long condition and the way it affects a patient can change over time. Therefore, there is a critical need for additional treatment options.
“With a quarter-century of experience and commitment to the treatment of rheumatic diseases, our focus remains on areas of high unmet need like systemic lupus erythematosus, and we look forward to further evaluation of the potential benefits that upadacitinib could bring to patients.”
The company is advancing its upadacitinib clinical programme in SLE to Phase III trial, based on the data from Phase II SLEek trial.
