AbbVie announced that upadacitinib (RINVOQ) alone or as a combination therapy has met the primary and key secondary endpoints in the phase 2 SLEek study in patients with moderately to severely active systemic lupus erythematosus (SLE).
The mid-stage clinical trial was evaluating upadacitinib 30mg alone and in combination [ABBV-599 high dose (elsubrutinib 60 mg and upadacitinib 30 mg)] in SLE patients who continued to get standard lupus therapies.
Developed by AbbVie, upadacitinib is a selective and reversible JAK inhibitor.
In the SLEek study, 54.8% of patients receiving 30mg of the JAK inhibitor and 48.5% of patients receiving ABBV-599 high dose achieved the primary endpoint of SLE Responder Index (SRI-4) and steroid dose less than or equal to 10mg prednisone equivalent once per day at week 24. This was in comparison to 37.3% people on placebo.
At the end of week 48, in the two active treatment groups, the key secondary endpoints were also achieved as upadacitinib 30mg and ABBV-599 high dose groups showed greater treatment effects compared to placebo.
The results included lupus flares measured by the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) and time to first flare.
AbbVie chief medical officer and development and regulatory affairs SVP Roopal Thakkar said: “There are limited treatment options for people living with SLE, leaving physicians challenged on how to effectively slow disease progression and limit potential organ damage in their patients.
“As a leader in immunology, AbbVie is committed to advancing care in areas of unmet need, such as SLE. We are encouraged by these positive Phase 2 data and look forward to continuing to study upadacitinib for systemic lupus erythematosus in two Phase 3 trials as part of our ongoing clinical programme.”
The SLEek trial enrolled 341 patients undergoing standard lupus therapy. They were randomised to get once daily ABBV-599 high dose, ABBV-599 low dose, elsubrutinib 60mg, upadacitinib 30mg, or placebo.
Based on the findings of the SLEek study, the pharmaceutical major is advancing the JAK inhibitor to phase 3.