Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Vanliga biverkningar

Vanliga biverkningar under behandling (TEAE) definierades som sådana som rapporterades hos ≥2 % (före avrundning) av patienterna i någon behandlingsgrupp.

Common adverse event in the label

The most commonly reported adverse drug reactions (ADRs) occurring in ≥ 2 % of patients treated with baricitinib monotherapy or in combination with conventional synthetic DMARDs were increased LDL cholesterol (33.6 %), upper respiratory tract infections (14.7 %) and nausea (2.8 %). Infections reported with Baricitinib treatment included Herpes zoster.1

A total of 3,464 patients were treated with baricitinib in clinical studies in rheumatoid arthritis representing 4214 patient-years of exposure. Of these, 2166 rheumatoid arthritis patients were exposed to baricitinib for at least one year. Six placebo-controlled studies were integrated (997 patients on 4 mg once daily and 1070 patients on placebo) to evaluate the safety of baricitinib in comparison to placebo for up to 16 weeks after treatment initiation.1

Table 1.  Adverse Reactions1

System Organ Class

Very common

Common

Uncommon

Infections and infestations

Upper respiratory tract infectionsa

Herpes zoster,

Herpes simplexb

Gastroenteritis

Urinary tract infections

Pneumonia

 

Blood and lymphatic system disorders

 

Thrombocytosis

>600 x 109 cells/Lc

Neutropaenia

<1 x 109 cells/Lc

Metabolism and nutrition disorders

Hypercholesterolaemiac

 

Hypertriglyceridaemiac

Gastrointestinal disorders

 

Nausea

 

Hepatobiliary disorders

 

ALT increased ≥3 x ULNc

AST increased ≥3 x ULNc

Skin and subcutaneous tissue disorders

 

Rash

Acne

Immune disorders



Swelling of the face, Urticaria

Respiratory, thoracic, mediastinal disorders



Pulmonary embolism

Vascular disorders



Deep Vein Thrombosis

Investigations

 

 

Weight increased

Creatine phosphokinase increased >5 x ULNc

 Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).

a Combined term (acute sinusitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, tracheitis, upper respiratory tract infection)

b Combined term (eczema herpeticum, herpes simplex, ophthalmic herpes simplex, oral herpes)

c Includes changes detected during laboratory monitoring

The information from the Summary of Product Characteristics and from the clinical data can vary. Any differences in data are dependent on factors such as the specific populations, dosing groups analyzed, and the cut-off dates for the analyses.

Common Side Effects in the clinical studies

The 7-study pooled dataset included patients with RA randomized to BARI 4 mg (N=1142, PYE=471.8) or placebo (N=1215, PYE=450.8) from 3 phase 2 studies and 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON and RA-BALANCE). Patients in the placebo group could have been taking background MTX or other conventional DMARDs. Evaluation time periods included through

  • the 12-week placebo-controlled period in phase 2 studies

  • 16 weeks of assigned treatment before any opportunity for rescue therapy in phase 3 studies, and

  • 24 weeks of assigned treatment or until rescue in phase 3 studies.2,3

Data from BARI 2 mg (N=479, PYE=185.8) is derived from 4 of these studies in which both BARI 2 mg and BARI 4 mg were options during randomization (2 phase 2 studies as well as RA-BUILD and RA-BEACON).2,3

Treatment-emergent adverse event occurring in ≥2% of patients in the 7-study dataset are presented in Table 2.

  • A statistically significantly larger proportion of patients had blood creatine phosphokinase (CPK) increased, hypercholesterolemia, hyperlipidemia, and abdominal pain upper in the BARI 4-mg group compared with the placebo group.  A statistically significantly smaller proportion of patients had back pain in the BARI 4-mg group compared with the placebo group.4

  • A statistically significantly larger proportion of patients had blood CPK increased, hypertension and abdominal pain upper in the BARI 2-mg group compared with the placebo group.4

Table 2. Treatment-Emergent Adverse Events Occurring in ≥ 2% of Patients in the 7-Study Integrated Safety Dataset by MedDRA Preferred Term Up to Week 164










Preferred Term

PBO (N=1215)

(PYE = 343.5)

BARI 2-mg (N=479)

(PYE = 137.3)


BARI 4-mg (N=1142)

(PYE = 335.4)

BARI 4-mg vs. PBO

BARI 2-mg vs. PBO


n (%)

EAIR

n (%)

EAIR

n (%)

EAIR

p-valuea

p-valuea b

Upper respiratory tract infection

57 (4.7)

16.6

27 (5.6)

19.7

70 (6.1)

20.9

0.183

0.636

Nasopharyngitis

56 (4.6)

16.3

16 (3.3)

11.7

60 (5.3)

17.9

0.457

0.267

Headache

40 (3.3)

11.6

30 (6.3)

21.8

43 (3.8)

12.8

0.631

0.180

Blood CPK increased

6 (0.5)

1.7

11 (2.3)

8.0

41 (3.6)

12.2

0.001

0.011

UTI

34 (2.8)

9.9

17 (3.5)

12.4

40 (3.5)

11.9

0.347

0.366

Anaemia

35 (2.9)

10.2

8 (1.7)

5.8

32 (2.8)

9.5

0.774

1.000

Bronchitis

31 (2.6)

9.0

12 (2.5)

8.7

32 (2.8)

9.5

0.739

0.318

Hyper-cholesterolemia

17 (1.4)

4.9

7 (1.5)

5.1

31 (2.7)

9.2

0.019

0.599

Hyperlipidemia

16 (1.3)

4.7

5 (1.0)

3.6

31 (2.7)

9.2

0.018

0.840

Nausea

17 (1.4)

4.9

13 (2.7)

9.5

28 (2.5)

8.3

0.078

0.629

Diarrhoea

36 (3.0)

10.5

16 (3.3)

11.7

26 (2.3)

7.8

0.227

0.471

Cough

19 (1.6)

5.5

9 (1.9)

6.6

28 (2.5)

8.3

0.141

0.815

Hypertension

24 (2.0)

7.0

16 (3.3)

11.7

27 (2.4)

8.0

0.605

0.021

Pharyngitis

14 (1.2)

4.1

10 (2.1)

7.3

23 (2.0)

6.9

0.086

0.057

Abdominal pain upper

6 (0.5)

1.7

10 (2.1)

7.3

17 (1.5)

5.1

0.015

0.040

Rheumatoid arthritis

24 (2.0)

7.0

5 (1.0)

3.6

14 (1.2)

4.2

0.123

0.256

Back pain

28 (2.3)

8.2

14 (2.9)

10.2

12 (1.1)

3.6

0.013

0.514

Vomiting

7 (0.6)

2.0

11 (2.3)

8.0

13 (1.1)

3.9

0.178

0.057

Sinusitis

12 (1.0)

3.5

10 (2.1)

7.3

11 (1.0)

3.3

0.941

0.240

Abbreviations: BARI = baricitinib; CPK = creatine phosphokinase; EAIR = exposure adjusted incidence rate; N = number of patients in the safety analysis set; n = number of patients in specified category; PBO = placebo; PYE = patient-years of exposure; UTI = urinary tract infection.
Notes: Percentages are based on the number of patients in each treatment group (N); EAIR is expressed as the number of patients experiencing an adverse event per 100 patient years of exposure to treatment and is derived as 100 times the incidence of the event divided by the sum of all patient exposure time (in years for the specific treatment group censored at rescue). Preferred terms are sorted by decreasing frequency in the BARI 4-mg group.

a p-value from Cochran-Mantel-Haenszel (CMH) test stratified by study.

b p-values for the BARI 2 mg vs placebo comparison calculated using the 4-study placebo-controlled dataset placebo group consisting of 551 patients and 150.0 PYE.

Reference

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

2. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Ann Rheum Dis. 2019;78(2):308-309. http://dx.doi.org/10.1136/annrheumdis-2019-eular.691

3. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Presented as an oral presentation at: European League Against Rheumatism (EULAR) Annual Meeting; June 12-15, 2019; Madrid, Spain.

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

Glossary

BARI = baricitinib

CPK = creatine phosphokinase

MTX = methotrexate

PYE = patient-years of exposure

RA = rheumatoid arthritis

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 M06 17

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