Summary
Concomitant
use of antibiotics was permitted in the RA clinical trial program. No
analyses have been conducted on the effects on the efficacy and
safety of
BARI
with concomitant antibiotic treatment, or
antibiotic
treatment with concomitant BARI treatment.1
Potential
for Drug-Drug Interactions Based on Pharmacology/Pharmacokinetics
Studies
Based
on clinical pharmacology studies, no clinically relevant effects on
BARI PK occurred with the co-administration of BARI and
a
CYP3A inhibitor
a
CYP2C19/CYP2C9/CYP3A inhibitor
a
CYP3A inducer (rifampicin), or
a
Pgp inhibitor.2
Co-administration
with BARI had no clinically relevant effects on the PK of,
a
CYP3A substrate
a
OATP1B1 substrate
a
Pgp substrate, or
an
OAT1, OAT3, and BCRP substrate.2,3
Concomitant
Use of Antibiotics in Phase 3 Clinical Trials
For
data on concomitant antibiotic therapies administered for RA in the 4
phase 3 clinical studies, see
Each
of the 4 phase 3 studies in the clinical program evaluated a distinct
treatment population of patients with moderate-to-severe RA.
RA-BEGIN compared
BARI 4 mg monotherapy, BARI 4 mg plus MTX, and MTX monotherapy in
patients who had limited or no prior treatment with MTX and were
naïve to other DMARDs.4
The
study population of DMARD-naïve patients from the RA-BEGIN study
is not included in the approved label. However, the RA-BEGIN study is
supportive for the target population of patients with an inadequate
response to, or intolerance to, other DMARDs.3
Table
1. Concomitant Antibiotics Therapies Administered for Rheumatoid
Arthritis in Study RA-BEGIN1
|
ATC
Level 2 Term
(Preferred Name)
|
MTX
(N=210)
n (%)
|
BARI
4 mg (N=159)
n (%)
|
BARI
4 mg + MTX (N=215)
n (%)
|
|
Antibacterials
for systemic use
|
49
(23.3)
|
39
(24.5)
|
83
(38.6)
|
|
Amoxicillin
|
3
(1.4)
|
5
(3.1)
|
21
(9.8)
|
|
Amoxicillin
w/Clavulanate
|
7
(3.3)
|
4
(2.5)
|
17
(7.9)
|
|
Ciprofloxacin
|
12
(5.7)
|
10
(6.3)
|
12
(5.6)
|
|
Clarithromycin
|
4
(1.9)
|
3
(1.9)
|
12
(5.6)
|
|
Azithromycin
|
5
(2.4)
|
4
(2.5)
|
11
(5.1)
|
|
Ceftriaxone
|
4
(1.9)
|
2
(1.3)
|
8
(3.7)
|
|
Levofloxacin
|
6
(2.9)
|
6
(3.8)
|
8
(3.7)
|
|
Cefuroxime
|
1
(0.5)
|
0
|
5
(2.3)
|
|
Doxycycline
|
1
(0.5)
|
2
(1.3)
|
5
(2.3)
|
|
Sulfamethoxazole/
trimethoprim
|
2
(1.0)
|
0
|
5
(2.3)
|
|
Cefcapene
|
0
|
2
(1.3)
|
4
(1.9)
|
|
Clindamycin
|
0
|
2
(1.3)
|
4
(1.9)
|
|
Cefdinir
|
2
(1.0)
|
0
|
3
(1.4)
|
|
Metronidazole
|
2
(1.0)
|
3
(1.9)
|
3
(1.4)
|
|
Nitrofurantoin
|
0
|
2
(1.3)
|
3
(1.4)
|
|
Norfloxacin
|
0
|
1
(0.6)
|
3
(1.4)
|
|
Vancomycin
|
2
(1.0)
|
0
|
3
(1.4)
|
|
Cefalexin
|
2
(1.0)
|
1
(0.6)
|
2
(0.9)
|
|
Cefotiam
|
0
|
0
|
2
(0.9)
|
|
Erythromycin
|
0
|
0
|
2
(0.9)
|
|
Fosfomycin
|
0
|
0
|
2
(0.9)
|
|
Garenoxacin
|
2
(1.0)
|
0
|
2
(0.9)
|
|
Gentamicin
|
0
|
0
|
2
(0.9)
|
|
Ofloxacin
|
1
(0.5)
|
0
|
2
(0.9)
|
|
Sitafloxacin
|
0
|
0
|
2
(0.9)
|
|
Ampicillin
|
3
(1.4)
|
0
|
1
(0.5)
|
|
Antibacterials
(non-specified)
|
0
|
0
|
1
(0.5)
|
|
Carbenin
|
0
|
0
|
1
(0.5)
|
|
Cefazolin
|
0
|
0
|
1
(0.5)
|
|
Cefditoren
|
0
|
0
|
1
(0.5)
|
|
Cefepime
|
0
|
0
|
1
(0.5)
|
|
Dicloxacillin
|
0
|
0
|
1
(0.5)
|
|
Duocid
(Ampicillin/Sulbactam)
|
0
|
0
|
1
(0.5)
|
|
Flucloxacillin
|
0
|
1
(0.6)
|
1
(0.5)
|
|
Fusidic
Acid
|
0
|
0
|
1
(0.5)
|
|
Lincomycin
|
0
|
0
|
1
(0.5)
|
|
Lymecycline
|
0
|
0
|
1
(0.5)
|
|
Meropenem
|
0
|
0
|
1
(0.5)
|
|
Moxifloxacin
|
1
(0.5)
|
1
(0.6)
|
1
(0.5)
|
|
Ornidazole
|
0
|
0
|
1
(0.5)
|
|
Cefaclor
|
1
(0.5)
|
0
|
0
|
|
Cefadroxil
|
1
(0.5)
|
0
|
0
|
|
Cefixime
|
3
(1.4)
|
0
|
0
|
|
Cefmetazole
|
1
(0.5)
|
0
|
0
|
|
Cefpodoxime
|
0
|
1
(0.6)
|
0
|
|
Ceftazidime
|
0
|
1
(0.6)
|
0
|
|
Clavulanic
Acid
|
1
(0.5)
|
0
|
0
|
|
Gatifloxacin
|
1
(0.5)
|
0
|
0
|
|
Isepamicin
|
0
|
1
(0.6)
|
0
|
|
Neomycin
|
1
(0.5)
|
0
|
0
|
|
Nitroxoline
|
0
|
1
(0.6)
|
0
|
|
Oxacillin
|
1
(0.5)
|
0
|
0
|
|
Penicillin
Nos
|
1
(0.5)
|
0
|
0
|
|
Sulperazon
|
1
(0.5)
|
0
|
0
|
|
Telithromycin
|
1
(0.5)
|
0
|
0
|
Abbreviations:
ATC = Anatomical Therapeutic Chemical classification system; BARI =
baricitinib; MTX = methotrexate.
Note:
Preferred names were sorted within the ATC class by descending
frequency in the BARI 4-mg + MTX group. The table includes data up to
rescue from weeks 0 through 52 in the safety population.
RA-BEAM compared
BARI 4 mg vs placebo or adalimumab, with background MTX, in patients
with inadequate response to MTX. 5
Table
2. Concomitant Antibiotic Therapies Administered for Rheumatoid
Arthritis in RA-BEAM1
|
ATC
Level 2 Term
(Preferred Name)
|
Placebo
(N=488)
n (%)
|
BARI
4 mg (N=487)
n (%)
|
ADA
(N=330)
n (%)
|
|
Antibacterials
for systemic use
|
91
(18.6)
|
174
(35.7)
|
104
(31.5)
|
|
Ciprofloxacin
|
16
(3.3)
|
34
(7.0)
|
20
(6.1)
|
|
Amoxicillin
|
17
(3.5)
|
31
(6.4)
|
21
(6.4)
|
|
Levofloxacin
|
15
(3.1)
|
29
(6.0)
|
18
(5.5)
|
|
Amoxicillin
w/ clavulanate
|
11
(2.3)
|
28
(5.7)
|
19
(5.8)
|
|
Clarithromycin
|
8
(1.6)
|
22
(4.5)
|
10
(3.0)
|
|
Azithromycin
|
10
(2.0)
|
17 (3.5)
|
14
(4.2)
|
|
Sulfamethoxazole/trimethoprim
|
4
(0.8)
|
12
(2.5)
|
4
(1.2)
|
|
Cefalexin
|
2
(0.4)
|
10
(2.1)
|
5
(1.5)
|
|
Clindamycin
|
2
(0.4)
|
10
(2.1)
|
5
(1.5)
|
|
Cefcapene
|
2
(0.4)
|
9
(1.8)
|
3
(0.9)
|
|
Cefdinir
|
2
(0.4)
|
8
(1.6)
|
2
(0.6)
|
|
Metronidazole
|
3
(0.6)
|
7
(1.4)
|
5
(1.5)
|
|
Norfloxacin
|
0
|
6
(1.2)
|
3
(0.9)
|
|
Ampicillin
|
1
(0.2)
|
5
(1.0)
|
1
(0.3)
|
|
Cefaclor
|
1
(0.2)
|
5
(1.0)
|
3
(0.9)
|
|
Ceftriaxone
|
3
(0.6)
|
5
(1.0)
|
9
(2.7)
|
|
Nitrofurantoin
|
5
(1.0)
|
5
(1.0)
|
3
(0.9)
|
|
Akritoin
|
1
(0.2)
|
4
(0.8)
|
1
(0.3)
|
|
Cefuoxime
|
2
(0.4)
|
4
(0.8)
|
4
(1.2)
|
|
Clavulanic
Acid
|
3
(0.6)
|
4
(0.8)
|
2
(0.6)
|
|
Doxycycline
|
0
|
4
(0.8)
|
3
(0.9)
|
|
Cefditoren
|
3
(0.6)
|
3
(0.6)
|
5
(1.5)
|
|
Fosfomycin
|
2
(0.4)
|
3
(0.6)
|
2
(0.6)
|
|
Garenoxacin
|
3
(0.6)
|
3
(0.6)
|
6
(1.8)
|
|
Azo-wintomylon
|
0
|
2
(0.4)
|
0
|
|
Cefazolin
|
0
|
2
(0.4)
|
1
(0.3)
|
|
Cefpodoxime
|
1
(0.2)
|
2
(0.4)
|
1
(0.3)
|
|
Dicloxacillin
|
0
|
2
(0.4)
|
2
(0.6)
|
|
Erythromycin
|
1
(0.2)
|
2
(0.4)
|
1
(0.3)
|
|
Flucloxacillin
|
0
|
2
(0.4)
|
1
(0.3)
|
|
Gentamicin
|
2
(0.4)
|
2
(0.4)
|
1
(0.3)
|
|
Moxifloxacin
|
0
|
2
(0.4)
|
1
(0.3)
|
|
Sitafloxacin
|
0
|
2
(0.4)
|
0
|
|
Sulfamethoxazole
|
0
|
2
(0.4)
|
1
(0.3)
|
|
Trimethoprim
|
0
|
2
(0.4)
|
1
(0.3)
|
|
Benzylpenicillin
|
0
|
1
(0.2)
|
1
(0.3)
|
|
Cefixime
|
1
(0.2)
|
1
(0.2)
|
0
|
|
Cefotiam
|
1
(0.2)
|
1
(0.2)
|
0
|
|
Cefteram
|
0
|
1
(0.2)
|
0
|
|
Josamycin
|
0
|
1
(0.2)
|
0
|
|
Lincomycin
|
0
|
1
(0.2)
|
2
(0.6)
|
|
Meropenem
|
0
|
1
(0.2)
|
0
|
|
Minocycline
|
1
(0.2)
|
1
(0.2)
|
1
(0.3)
|
|
Nitroxoline
|
0
|
1
(0.2)
|
0
|
|
Ofloxacin
|
1
(0.2)
|
1
(0.2)
|
3
(0.9)
|
|
Penicillin
Nos
|
1
(0.2)
|
1
(0.2)
|
1
(0.3)
|
|
Roxithromycin
|
0
|
1
(0.2)
|
1
(0.3)
|
|
Tinidazole
|
0
|
1
(0.2)
|
0
|
|
Antibiotics
(non-specified)
|
2
(0.4)
|
0
|
0
|
|
Cefazolin
w/dextrose
|
0
|
0
|
1
(0.3)
|
|
Cefprozil
|
0
|
0
|
1
(0.3)
|
|
Chloramphenicol
|
3
(0.6)
|
0
|
0
|
|
Polymixin
E
|
0
|
0
|
1
(0.3)
|
|
Ertapenem
|
1
(0.2)
|
0
|
0
|
|
Fusafungine
|
0
|
0
|
1
(0.3)
|
|
Gatifloxacin
|
0
|
0
|
1
(0.3)
|
|
Nalidixic
acid
|
0
|
0
|
1
(0.3)
|
|
Oxacillin
|
0
|
0
|
1
(0.3)
|
|
Oxytetracycline
|
1
(0.2)
|
0
|
1
(0.3)
|
|
Phenoxymethylpenicillin
|
0
|
0
|
1
(0.3)
|
|
Piperacillin
|
0
|
0
|
1
(0.3)
|
|
Pristinamycin
|
0
|
0
|
2
(0.6)
|
|
Ribostamycin
|
0
|
0
|
1
(0.3)
|
|
Spiramycin
|
0
|
0
|
1
(0.3)
|
|
Cefoperazone/Sulbactam
|
1
(0.2)
|
0
|
0
|
|
Ampicillin/Sulbactam
|
1
(0.2)
|
0
|
1
(0.3)
|
|
Vancomycin
|
1
(0.2)
|
0
|
2
(0.6)
|
Abbreviations:
ADA = adalimumab; ATC = Anatomical Therapeutic Chemical
classification system; BARI = baricitinib.
Note:
Preferred names were sorted within the ATC class by descending
frequency in the BARI 4-mg group. The table includes data up to
rescue or switch from weeks 0 through 52 in the safety population.
RA-BUILD compared
BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy, in
patients with inadequate response to csDMARDs.6
Table
3. Concomitant Antibiotic Therapies Administered for Rheumatoid
Arthritis in Study RA-BUILD1
|
ATC
Level 2 Term (Preferred Name)
|
Placebo
(N=228)
n (%)
|
BARI
2 mg (N=229)
n (%)
|
BARI
4 mg (N=227)
n (%)
|
|
Antibacterials
for systemic use
|
46
(20.2)
|
47
(20.5)
|
67
(29.5)
|
|
Amoxicillin
w/ Clavulanate
|
6 (2.6)
|
3
(1.3)
|
14
(6.2)
|
|
Amoxicillin
|
9
(3.9)
|
8
(3.5)
|
13
(5.7)
|
|
Azithromycin
|
8
(3.5)
|
9
(3.9)
|
13
(5.7)
|
|
Ciprofloxacin
|
3
(1.3)
|
12
(5.2)
|
11
(4.8)
|
|
Levofloxacin
|
7
(3.1)
|
2
(0.9)
|
8
(3.5)
|
|
Clarithromycin
|
3
(1.3)
|
2
(0.9)
|
7
(3.1)
|
|
Cefalexin
|
1
(0.4)
|
5
(2.2)
|
6
(2.6)
|
|
Piperacillin
w/ Tazobactam
|
0
|
1
(0.4)
|
5
(2.2)
|
|
Doxycycline
|
3
(1.3)
|
3
(1.3)
|
4
(1.8)
|
|
Nitrofurantoin
|
1
(0.4)
|
4
(1.7)
|
3
(1.3)
|
|
Cefixime
|
0
|
1
(0.4)
|
2
(0.9)
|
|
Clindamycin
|
2
(0.9)
|
0
|
2
(0.9)
|
|
Metronidazole
|
0
|
2
(0.9)
|
2
(0.9)
|
|
Moxifloxacin
|
0
|
2
(0.9)
|
2
(0.9)
|
|
Norfloxacin
|
0
|
1
(0.4)
|
2
(0.9)
|
|
Akritoin
|
1
(0.4)
|
1
(0.4)
|
1
(0.4)
|
|
Sulfamethoxazole/
trimethoprim
|
2
(0.9)
|
1
(0.4)
|
1
(0.4)
|
|
Cefalotin
|
0
|
0
|
1
(0.4)
|
|
Cefazolin
|
0
|
1
(0.4)
|
1
(0.4)
|
|
Cefditoren
|
0
|
0
|
1
(0.4)
|
|
Cefoperazone
|
0
|
0
|
1
(0.4)
|
|
Cefotaxime
|
0
|
0
|
1
(0.4)
|
|
Cefotiam
|
0
|
0
|
1
(0.4)
|
|
Cefpodoxime
|
0
|
0
|
1
(0.4)
|
|
Cefuroxime
|
1
(0.4)
|
0
|
1
(0.4)
|
|
Clavulanic
acid
|
0
|
1
(0.4)
|
1
(0.4)
|
|
Flucloxacillin
|
2
(0.9)
|
2
(0.9)
|
1
(0.4)
|
|
Minocycline
|
0
|
0
|
1
(0.4)
|
|
Sulbactam
|
0
|
0
|
1
(0.4)
|
|
Sulfathiozole
|
0
|
0
|
1
(0.4)
|
|
Tinidazole
|
0
|
0
|
1
(0.4)
|
|
Ampicillin/Sulbactam
|
0
|
0
|
1
(0.4)
|
|
Amikacin
|
0
|
1
(0.4)
|
0
|
|
Cefamandole
|
1
(0.4)
|
0
|
0
|
|
Cefcapene
|
1
(0.4)
|
0
|
0
|
|
Cefdinir
|
0
|
1
(0.4)
|
0
|
|
Ceftriaxone
|
3
(1.3)
|
2
(0.9)
|
0
|
|
Dexchlorpheniramine
|
0
|
1
(0.4)
|
0
|
|
Dicloxacillin
|
1
(0.4)
|
0
|
0
|
|
Erythromycin
|
0
|
1
(0.4)
|
0
|
|
Fosomycin
|
2
(0.9)
|
0
|
0
|
|
Garenoxacin
|
2
(0.9)
|
1
(0.4)
|
0
|
|
Lincomycin
|
0
|
1
(0.4)
|
0
|
|
Meropenem
|
1
(0.4)
|
0
|
0
|
|
Netilmicin
|
0
|
1
(0.4)
|
0
|
|
Oxacillin
|
1
(0.4)
|
0
|
0
|
|
Polymyxin
B
|
1
(0.4)
|
0
|
0
|
|
Vancomycin
|
2
(0.9)
|
1
(0.4)
|
0
|
Abbreviations:
ATC = Anatomical Therapeutic Chemical classification system; BARI =
baricitinib.
Note: Preferred names were sorted within the ATC
class by descending frequency in the BARI 4-mg group. The table
includes data up to rescue from weeks 0 through 24 in the safety
population.
RA-BEACON compared
BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy,
in patients with an inadequate response to at least one TNF
inhibitor, who may also have had an inadequate response to one or
more non-TNF inhibitor biologic DMARDs.7
Table
4. Concomitant Antibiotics Therapies Administered for Rheumatoid
Arthritis in Study RA-BEACON1
|
ATC
Level 2 Term (Preferred Name)
|
Placebo
(N=176)
n (%)
|
BARI
2 mg (N=174)
n (%)
|
BARI
4 mg (N=177)
n (%)
|
|
Antibacterials
for systemic use
|
32
(18.2)
|
57
(32.8)
|
50
(28.2)
|
|
Amoxicillin
w/ Clavulanate
|
5
(2.8)
|
6
(3.4)
|
13
(7.3)
|
|
Azithromycin
|
3
(1.7)
|
13
(7.5)
|
8
(4.5)
|
|
Cefalexin
|
0
|
4
(2.3)
|
7
(4.0)
|
|
Ciprofloxacin
|
4
(2.3)
|
7
(4.0)
|
7
(4.0)
|
|
Amoxicillin
|
9
(5.1)
|
6
(3.4)
|
6
(3.4)
|
|
Sulfamethoxazole/
trimethoprim
|
0
|
4
(2.3)
|
5
(2.8)
|
|
Moxifloxacin
|
0
|
1
(0.6)
|
4
(2.3)
|
|
Ceftriaxone
|
0
|
1
(0.6)
|
3
(1.7)
|
|
Cefuroxime
|
2
(1.1)
|
2
(1.1)
|
2
(1.1)
|
|
Clarithromycin
|
3
(1.7)
|
6
(3.4)
|
2
(1.1)
|
|
Levofloxacin
|
2
(1.1)
|
4
(2.3)
|
2
(1.1)
|
|
Minocycline
|
0
|
0
|
2
(1.1)
|
|
Ampicillin
|
0
|
1
(0.6)
|
1
(0.6)
|
|
Cefadroxil
|
0
|
0
|
1
(0.6)
|
|
Cefazolin
|
1
(0.6)
|
2
(1.1)
|
1
(0.6)
|
|
Cefapene
|
0
|
0
|
1
(0.6)
|
|
Cefixime
|
0
|
0
|
1
(0.6)
|
|
Cefprozil
|
0
|
0
|
1
(0.6)
|
|
Clindamycin
|
2
(1.1)
|
2
(1.1)
|
1
(0.6)
|
|
Doxycycline
|
0
|
2
(1.1)
|
1
(0.6)
|
|
Gentamicin
|
0
|
0
|
1
(0.6)
|
|
Lomefloxacin
|
0
|
0
|
1
(0.6)
|
|
Metronidazole
|
2
(1.1)
|
1
(0.6)
|
1
(0.6)
|
|
Nitrofurantoin
|
0
|
2
(1.1)
|
1
(0.6)
|
|
Phenoxymethylpenicillin
|
0
|
2
(1.1)
|
1
(0.6)
|
|
Piperacillin
w/ Tazobactam
|
2
(1.1)
|
1
(0.6)
|
1
(0.6)
|
|
Roxithromycin
|
0
|
3
(1.7)
|
1
(0.6)
|
|
Vancomycin
|
0
|
0
|
1
(0.6)
|
|
Benzylpenicillin
|
0
|
1
(0.6)
|
0
|
|
Cefdinir
|
0
|
1
(0.6)
|
0
|
|
Cefditoren
|
1
(0.6)
|
0
|
0
|
|
Cefmetazole
|
0
|
1
(0.6)
|
0
|
|
Dicloxacillin
|
0
|
1
(0.6)
|
0
|
|
Erythromycin
|
0
|
1
(0.6)
|
0
|
|
Faropenem
|
1
(0.6)
|
0
|
0
|
|
Fosfomycin
|
1
(0.6)
|
2
(1.1)
|
0
|
|
Fusidic
Acid
|
0
|
1
(0.6)
|
0
|
|
Garenoxacin
|
1
(0.6)
|
0
|
0
|
|
Mecillinam
|
0
|
1
(0.6)
|
0
|
|
Meropenem
|
0
|
1
(0.6)
|
0
|
|
Norfloxacin
|
0
|
1
(0.6)
|
0
|
|
Ofloxacin
|
0
|
2
(1.1)
|
0
|
|
Penicillin
Nos
|
1
(0.6)
|
1
(0.6)
|
0
|
Abbreviations:
ATC = Anatomical Therapeutic Chemical classification system; BARI =
baricitinib.
Note: Preferred names were sorted within the ATC
class by descending frequency in the BARI 4 mg group. The table
includes data up to rescue from weeks 0 through 24 in the safety
population.
References
1.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2.
Payne C, Zhang X, Shahri N, et al. Evaluation of potential drug-drug
interactions with baricitinib. Poster presented at: The Annual
Meeting of the American Association of Pharmaceutical Scientists
(AAPS); October 25-29, 2015; Orlando, FL.
3.
Olumiant [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
4.
Fleischmann R, Schiff M, van der Heijde D, et al. Baricitinib,
methotrexate, or combination in patients with rheumatoid arthritis
and no or limited prior disease-modifying antirheumatic drug
treatment. Arthritis Rheumatol. 2017;69(3):506-517.
http://dx.doi.org/10.1002/art.39953
5.
Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus
placebo or adalimumab in rheumatoid arthritis. N Engl J Med.
2017;376(7):652-662. http://dx.doi.org/10.1056/NEJMoa1608345
6.
Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in
patients with inadequate response or intolerance to conventional
synthetic DMARDs: results from the RA-BUILD study [published
correction appears in Ann Rheum Dis. 2017;76(9):1634.
http://dx.doi.org/10.1136/annrheumdis-2016-210094corr1
]. Ann Rheum Dis. 2017;76(1):88-95.
http://dx.doi.org/10.1136/annrheumdis-2016-210094
7.
Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with
refractory rheumatoid arthritis. N Engl J Med.
2016;374(13):1243-1252. http://dx.doi.org/10.1056/NEJMoa1507247
Glossary
BARI
= baricitinib
BCRP
= breast cancer resistance protein
csDMARD
= conventional synthetic disease-modifying antirheumatic drug
CYP
= cytochrome P450
DMARD
= disease-modifying antirheumatic drug
MTX
= methotrexate
OAT
= organic anion transporter
Pgp
= P-glycoprotein
PK =
pharmacokinetic
RA =
rheumatoid arthritis
TNF
= tumor necrosis factor
▼ This
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.