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Olumiant ® ▼ (baricitinib)
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Olumiant Summary of Product Characteristics (SmPC)
Olumiant® ▼ (baricitinib): Concomitant Use with Systemic Antibiotics in the RA Phase 3 Clinical Trials
Concomitant antibiotic medications were used in the phase 3 studies of baricitinib for the treatment of rheumatoid arthritis.
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,
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 |
MTX
(N=210) |
BARI
4 mg (N=159) |
BARI
4 mg + MTX (N=215) |
|
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 |
Placebo
(N=488) |
BARI
4 mg (N=487) |
ADA
(N=330) |
|
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) |
BARI
2 mg (N=229) |
BARI
4 mg (N=227) |
|
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) |
BARI
2 mg (N=174) |
BARI
4 mg (N=177) |
|
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.
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.
Date of Last Review: April 07, 2020
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