Olumiant ® (baricitinib) tabletter

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Olumiant®▼ (baricitinib): Samtidig användning med antiinflammatoriska läkemedel

Antiinflammatoriska läkemedel användes samtidigt i fas 3-studier av baricitinib för behandling av reumatoid artrit.

Information from the label

Concomitant use of the OAT3 inhibitors ibuprofen and diclofenac may lead to increased exposure of baricitinib, however their inhibition potential of OAT3 is less compared to probenecid and thus a clinically relevant interaction is not expected.1

Description of Baricitinib Rheumatoid Arthritis Phase 3 Clinical Trials

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.2

  • RA-BEAM compared BARI 4 mg vs placebo or adalimumab, with background MTX, in patients with inadequate response to MTX.3 

  • RA-BUILD compared BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy, in patients with inadequate response to csDMARDs.4

  • 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.5

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.1

Concomitant Use of Anti-inflammatory Therapies

Concomitant use of NSAIDs was permitted during the studies if the patient was on a stable dose for at least 6 weeks before planned randomization. Increase of NSAID dose or introduction of new NSAIDs was not permitted during the studies, unless a patient received rescue therapy. After rescue, new NSAIDs or increases in doses of ongoing concomitant NSAIDs were permitted. Dose reductions and termination of NSAIDs were permitted at any time.6

For data on concomitant anti-inflammatory therapies administered for RA in the 4 phase 3 clinical studies, see

Concomitant Aspirin as an Analgesic

For data on concomitant aspirin used as an analgesic in the 4 phase 3 clinical studies of BARI for the treatment of RA, see Table 5.

References

1. Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. 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

3. 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

4. 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

5. 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

6. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

BARI = baricitinib

csDMARD = conventional synthetic disease-modifying antirheumatic drug

DMARD = disease-modifying antirheumatic drug

MTX = methotrexate

NSAID = nonsteroidal anti-inflammatory drug

RA = rheumatoid arthritis

TNF = tumor necrosis factor

Appendix

Table 1. Concomitant Anti-inflammatory Therapies Administered for Rheumatoid Arthritis in Study RA-BUILD6

ATC Level 2 Term (Preferred Name)

Placebo (N=228)
n (%)

BARI 2 mg (N=229)
n (%)

BARI 4 mg (N=227)
n (%)

Anti-inflammatory and Antirheumatic Products

209 (92)

216 (94)

214 (94)

Methotrexate

168 (74)

171 (75)

173 (76)

Hydrochloroquine

54 (24)

63 (28)

54 (24)

Diclofenac

25 (11)

23 (10)

29 (13)

Celecoxib

33 (15)

30 (13)

27 (12)

Meloxicam

21 (9)

18 (8)

18 (8)

Naproxen

34 (15)

25 (11)

18 (8)

Etoricoxib

13 (6)

18 (8)

15 (7)

Ibuprofen

17 (8)

16 (7)

15 (7)

Aceclofenac

6 (3)

6 (3)

7 (3)

Loxoprofen

0

3 (1)

4 (2)

Ketoprofen

0

1 (0.4)

3 (1)

Acemetacin

0

1 (0.4)

2 (1)

Nabumetone

4 (2)

1 (0.4)

2 (1)

Bucillamine

0

0

1 (0.4)

Etodolac

0

0

1 (0.4)

Ketorolac

1 (0.4)

0

1 (0.4)

Nimesulide

1 (0.4)

4 (2)

1 (0.4)

Osyfen NS

0

0

1 (0.4)

Paracetamol Forte Raffo

0

0

1 (0.4)

Piroxicam

0

4 (2)

1 (0.4)

Sulindac

0

0

1 (0.4)

Vimovo

0

1 (0.4)

1 (0.4)

Ace Proxyvon

1 (0.4)

0

0

Aceclo Plus

2 (1)

1 (0.4)

0

Algiril

0

1 (0.4)

0

Arthrotec

2 (1)

0

0

Chondroitin

1 (0.4)

0

0

Cosamin

1 (0.4)

0

0

Dexketoprofen

1 (0.4)

1 (0.4)

0

Indometacin

2 (1)

1 (0.4)

0

Lornoxicam

2 (1)

0

0

Mefenamic Acid

0

1 (0.4)

0

Morniflumate

0

1 (0.4)

0

Rofecoxib

0

1 (0.4)

0

Talniflumate

0

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.

Table 2. Concomitant Anti-inflammatory Therapies Administered for Rheumatoid Arthritis in Study RA-BEACON6

ATC Level 2 Term (Preferred Name)

Placebo (N=176)
n (%)

BARI 2 mg (N=174)
n (%)

BARI 4 mg (N=177)
n (%)

Anti-inflammatory and Antirheumatic Products

161 (92)

163 (94)

169 (96)

Methotrexate

145 (82)

142 (82)

150 (85)

Diclofenac

32 (18)

18 (10)

28 (16)

Hydroxychloroquine

14 (8)

20 (12)

19 (11)

Ibuprofen

16 (9)

20 (12)

17 (10)

Naproxen

14 (8)

16 (9)

13 (7)

Celecoxib

16 (9)

13 (8)

11 (6)

Meloxicam

10 (6)

13 (8)

6 (3)

Nabumetone

4 (2)

2 (1)

6 (3)

Etodolac

3 (2)

4 (2)

5 (3)

Etoricoxib

7 (4)

6 (3)

3 (2)

Arthrotec

1 (0.6)

2 (1)

2 (1)

Indometacin

0

0

2 (1)

Ketoprofen

0

2 (1)

2 (1)

Lornoxicam

0

1 (0.6)

2 (1)

Aceclofenac

0

1 (0.6)

1 (0.6)

Bucillamine

0

1 (0.6)

1 (0.6)

Loxoprofen

0

2 (1)

1 (0.6)

Dexibuprofen

1 (0.6)

0

0

Ketorolac

1 (0.6)

1 (0.6)

0

Morniflumate

1 (0.6)

0

0

Nimesulide

1 (0.6)

1 (0.6)

0

Oxaprozin

0

1 (0.6)

0

Piroxicam

2 (1)

0

0

Sulindac

1 (0.6

0

0

Suprofen

0

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.

Table 3. Concomitant Anti-inflammatory Therapies Administered for Rheumatoid Arthritis in RA-BEAM6

ATC Level 2 Term
(Preferred Name)

Placebo (N=488)
n (%)

BARI 4 mg (N=487)
n (%)

ADA (N=330)
n (%)

Anti-inflammatory and Antirheumatic Products

488 (100)

487 (100)

330 (100)

Methotrexate

487 (99.8)

487 (100)

330 (100)

Diclofenac

94 (19.3)

106 (22)

74 (22)

Celecoxib

60 (12.3)

59 (12)

46 (14)

Meloxicam

52 (10.7)

53 (11)

31 (9)

Loxoprofen

29 (5.9)

38 (8)

17 (5)

Hydroxychroroquine

44 (9.0)

30 (6)

32 (10)

Naproxen

31 (6.4)

28 (6)

17 (5)

Ibuprofen

24 (4.9)

24 (5)

13 (4)

Aceclofenac

2 (0.4)

12 (3)

12 (4)

Etoricoxib

15 (3.1)

10 (2)

10 (3)

Nimesulide

10 (2)

10 (2)

8 (2)

Indometacin

10 (2)

6 (1)

4 (1)

Lornoxicam

2 (0.4)

6 (1)

6 (2)

Etodolac

10 (2)

5 (1)

4 (1)

Ketoprofen

7 (1)

5 (1)

7 (2)

Vimovo

4 (1)

4 (1)

0

Acemetacin

3 (0.6)

3 (0.6)

0

Bucillamine

1 (0.2)

2 (0.4)

0

Flurbiprofen

0

2 (0.4)

0

Ketorolac

2 (0.4)

2 (0.4)

0

Piroxicam

2 (0.4)

2 (0.4)

3 (0.9)

Sulindac

6 (1)

2 (0.4)

4 (1.2)

Arthrotec

3 (0.6)

1 (0.2)

0

Defenac-P

2 (0.4)

1 (0.2)

0

Dexibuprofen

0

1 (0.2)

0

Dexketoprofen

0

1 (0.2)

0

Dioxaflex Plus

0

1 (0.2)

0

Esomeprozole/Naproxen

0

1 (0.2)

0

Glucosamine

0

1 (0.2)

0

Indomethacin

0

1 (0.2)

0

Morniflumate

0

1 (0.2)

0

Talniflumate

0

1 (0.2)

1 (0.3)

Ampiroxicam

0

0

1 (0.3)

Blokium Cort

1 (0.2)

0

0

Diclonerve

1 (0.2)

0

0

Nabumetone

0

0

4 (1)

Oxaprozin

0

0

1 (0.3)

Rofecoxib

1 (0.2)

0

0

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.

Table 4. Concomitant Anti-inflammatory Therapies Administered for Rheumatoid Arthritis in Study RA-BEGIN6

ATC Level 2 Term
(Preferred Name)

MTX (N=210)
n (%)

BARI 4 mg (N=159)
n (%)

BARI 4 mg + MTX (N=215)
n (%)

Anti-inflammatory and Antirheumatic Products

155 (74)

126 (79)

160 (74)

Diclofenac

44 (21)

35 (22)

43 (20)

Naproxen

26 (12)

15 (9)

27 (13)

Ibuprofen

16 (8)

18 (11)

22 (10)

Celecoxib

21 (10)

10 (6)

16 (7)

Loxoprofen

12 (6)

14 (9)

13 (6)

Meloxicam

18 (9)

11 (7)

13 (6)

Etoricoxib

14 (7)

6 (4)

5 (2)

Sulindac

1 (0.5)

2 (1)

5 (2)

Nabumetone

1 (0.5)

1 (0.6)

4 (2)

Nimesulide

4 (2)

6 (4)

4 (2)

Indometacin

1 (0.5)

1 (0.6)

3 (1)

Vimovo

0

1 (0.6)

3 (1)

Aceclo Plus

0

3 (2)

2 (1)

Aceclofenac

2 (1.0)

1 (0.6)

2 (1)

Ampiroxicam

0

0

1 (0.5)

Arthrotec

0

0

1 (0.5)

Chondroitin

0

0

1 (0.5)

Etodolac

3 (1)

2 (1)

1 (0.5)

Glucosamine

0

1 (0.6)

1 (0.5)

Ketoprofen

0

1 (0.6)

1 (0.5)

Lornoxicam

2 (1.0)

1 (0.6)

1 (0.5)

Methotrexate

2 (1.0)

0

1 (0.5)

Piroxicam

0

0

1 (0.5)

Proglumetacin

0

0

1 (0.5)

Zaltoprofen

0

1 (0.6)

1 (0.5)

Diacerein

1 (0.5)

0

0

Hydroxychloroquine

1 (0.5)

1 (0.6)

0

Ketorolac

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.

Table 5. Concomitant Use of Aspirin as an Analgesic in Baricitinib Rheumatoid Arthritis Phase 3 Clinical Trials6

Study

Concomitant Use of ASA as an Analgesic by ATCa, n (%)

RA-BEACON (N=527)

BARI 2 mg (n=174)

0

BARI 4 mg (n=177)

1 (0.6)

Placebo (n=176)

0

RA-BUILD (N=684)

BARI 2 mg (n=229)

1 (0.4)

BARI 4 mg (n=227)

1 (0.4)

Placebo (n=228)

1 (0.4)

RA-BEAM (N=1305)

BARI 4 mg (n=487)

0

Adalimumab (n=330)

1 (0.3)

Placebo (n=488)

1 (0.2)

RA-BEGIN (N=584)

BARI 4 mg (n=159)

1 (0.6)

BARI 4 mg + MTX (n=215)

0

MTX (n=210)

0

Abbreviations: ASA = acetylsalicylic acid; ATC = Anatomical Therapeutic Chemical classification system; BARI = baricitinib; MTX = methotrexate.

a Dose or dose range was not collected.

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.

Datum fӧr senaste ӧversyn 2019 M01 29


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