RA ℞: Baricitinib

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
Baricitinib, alone or in combination with methotrexate,…
medscape.com

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 is a novel inhibitor of Janus kinases JAK1 and JAK2 that has been extensively studied in rheumatoid arthritis (RA).  Baricitinib (AKA Oluminant) was recently approved by the EMA for use in Europe at a once daily dose of 4 mg per day.  Regulatory approval in the USA is pending with the FD…
rheumnow.com

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
Superior to adalimumab for clinical and functional outcomes
medpagetoday.com

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

Baricitinib is an oral, small molecule, once-daily DMARD, that specifically inhibits Janus kinase 1 and 2 and is being developed for use in rheumatoid arthritis. With much of the developmental clinical trials completed, the drug is slated for review and potential approval near the end of the year.
rheumnow.com

Selective JAK1/JAK2 Inhibitor Linked with Clinical Improvement

In patients with rheumatoid arthritis (RA) with an inadequate response or intolerance to conventional…
mdedge.com

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

baricitinib

Eli Lilly and Company and Incyte Corporation today…
dddmag.com

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.


ardbeta.bmj.com

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

The European Commission has approved Eli Lilly’s…
rheumnow.com