Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study

RCT (n=648) reported that upadacitinib monotherapy showed statistically significant improvements in ACR20 and DAS28 (CRP) versus continuing methotrexate (MTX) in patients with an inadequate response to MTX with no new safety concerns.

Upadacitinib is an oral Janus kinase (JAK)1-selective inhibitor that has been filed with the European Medicines Agency for the treatment of rheumatoid arthritis (RA) in patients with inadequate response to either methotrexate or TNF inhibitors.

 

The following results were reported at 14 weeks:

 

- ACR20 response was achieved by more patients in the upadacitinib group vs MTX group (68% for 15mg and 71% for 30mg vs 41%; p<0.0001 for both doses vs MTX).

 

- DAS28(CRP) 3·2 or lower was met by more patients in the upadacitinib group vs MTX group (45% for 15mg and 53% for 30mg vs 19%; p<0.0001 for both doses vs MTX).

 

- Adverse events of interest for which a potential dose relationship was observed include herpes zoster.