BEGIN Study: Baricitinib Tops Methotrexate in Early Rheumatoid Arthritis
| Outcome | Baricitinib Alone, % | Baricitinib Plus Methotrexate, % | Methotrexate Alone, % |
| Week 24 | |||
| ACR20 | 77 | 78 | 62 |
| ACR50 | 60 | 63 | 43 |
| ACR70 | 42 | 40 | 21 |
| Week 52 | |||
| ACR20 | 73 | 73 | 56 |
| ACR50 | 57 | 62 | 38 |
| ACR70 | 42 | 46 | 25 |
In RA-BEGIN, Baricitinib alone at the higher 4mg dose was compared to MTX alone and to Baricitinib+MTX in early MTX-naïve RA patients. Both Baricitinib alone and in combination with MTX had superior efficacy compared to MTX alone.
The combination therapy may not appear to be superior to Baricitinib alone in this trial because mainly early and relatively mild and responsive RA patients were enrolled, and/or the higher 4mg dose was used. A difference in favour of combination therapy may emerge if a cohort of MTX and/or bDMARD inadequate responders were trialed.
BEAM Study: Baricitinib Beats Placebo and Adalimumab in Rheumatoid Arthritis
Baricitinib Scores High in Phase III
| PBO | BAR | ADA | |
| ACR20 % | 40 | 70* | 61 |
| ACR50 % | 17 | 45* | 35 |
| ACR70 % | 5 | 19* | 13 |
| *p < 0.05; BAR vs. ADA | |||
In RA-BEAM, Baricitinib monotherapy was pitted against Adalimumab monotherapy in RA patients who responded inadequately to MTX, and was superior. But an anti-TNF like Adalimumab should always be combined with MTX for optimal efficacy in RA.
BUILD Study – Baricitinib Shows Rapid Efficacy and X-ray Protection
Selective JAK1/JAK2 Inhibitor Linked with Clinical Improvement
In RA-BUILD, 2 doses of Baricitinib (2mg and 4mg daily) were compared to placebo (continued on csDMARD), in biologic-naïve RA patients who responded inadequately to any csDMARD. The higher dose was more effective, but had a case each of TB and non-melanoma skin cancer. Other side-effects included low white blood count and raised cholesterol.
BEYOND Study: Baricitinib Reduces Joint Damage Progression in RA Patients
In RA-BEYOND, the cohort completing RA-BUILD continued on another 6 months of Baricitinib as an open-label extension study. Joint damage on XRay was found to be prevented.
RA-BEACON looked at the effect Baricitinib 2mg and 4mg on patient-reported outcomes in patients who did not respond adequately to even a biologic DMARD, including anti-TNF. Compared to placebo (continued on csDMARD but over a month off bDMARD), Baricitinib at either dose improved pain, function, fatigue and quality of life, with the higher dose giving a faster response.
Baricitinib Approved in the EU for Use in Rheumatoid Arthritis
