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.

SE_cFAQ_BAR101_COMMON_SIDE_EFFECTS_RA
SE_cFAQ_BAR101_COMMON_SIDE_EFFECTS_RA
en-GB

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.1,2

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).1,2

Treatment-emergent adverse event occurring in ≥2% of patients in the 7-study dataset are presented in Treatment-Emergent Adverse Events Occurring in ≥ 2% of Patients in the 7-Study Integrated Safety Dataset by MedDRA Preferred Term Up to Week 16.

  • 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.3
  • 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.3
Treatment-Emergent Adverse Events Occurring in ≥ 2% of Patients in the 7-Study Integrated Safety Dataset by MedDRA Preferred Term Up to Week 163

Preferred Term

PBO (N=1215)

(PYE = 343.5)

PBO (N=1215)

(PYE = 343.5)


BARI 2-mg (N=479)

(PYE = 137.3)


BARI 2-mg (N=479)

(PYE = 137.3)



BARI 4-mg (N=1142)

(PYE = 335.4)

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.

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

bp-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.

Tabulated List of Adverse Reactions From the Label

Rheumatoid Arthritis

A total of 3,770 patients were treated with baricitinib in clinical studies in rheumatoid arthritis representing 10,127 patient-years of exposure. Of these, 2,960 rheumatoid arthritis patients were exposed to baricitinib for at least one year.4

Seven placebo-controlled studies were integrated (1,142 patients on 4 mg once daily and 1,215 patients on placebo) to evaluate the safety of baricitinib in comparison to placebo for up to 16 weeks after treatment initiation.4

Atopic Dermatitis

A total of 2,531 patients were treated with baricitinib in clinical studies in atopic dermatitis representing a total of 2,247 patient-years of exposure. Of these, 1,106 atopic dermatitis patients were exposed to baricitinib for at least one year.4

Five placebo-controlled studies were integrated (489 patients on 4 mg once daily and 743 patients on placebo) to evaluate the safety of baricitinib in comparison to placebo for up to 16 weeks after treatment initiation.4

Adverse Reactions

The frequencies in  Adverse Reactions are based on integrated data across both rheumatoid arthritis and atopic dermatitis indications unless stated otherwise; where notable differences in frequency are observed in one indication alone, these are presented in the footnotes below the table.4

 

 Adverse Reactions4

System Organ Class

Very common

Common

Uncommon

Infections and infestations

Upper respiratory tract infections

Herpes zostera

Herpes simplex

Gastroenteritis

Urinary tract infections

Pneumoniab

 

Blood and lymphatic system disorders

 

Thrombocytosis

>600 x 109 cells/Lc,b

Neutropaenia

<1 x 109 cells/Lc

Metabolism and nutrition disorders

Hypercholesterolaemiac

 

Hypertriglyceridaemiac

Nervous system disorders


Headache


Gastrointestinal disorders

 

Nauseab

Abdominal pain

Diverticulitis

Hepatobiliary disorders

 

ALT increased ≥3 x ULNc,b

AST increased ≥3 x ULNc

Skin and subcutaneous tissue disorders

 

Rash

Acned


Immune disorders



Swelling of the face, Urticaria

Respiratory, thoracic, mediastinal disorders



Pulmonary embolism

Vascular disorders



Deep Vein Thrombosis

Investigations

 

Creatine phosphokinase increased >5 x ULNc,d

Weight increased

aFrequency for herpes zoster is based on rheumatoid arthritis clinical trials.

bFrequency for pneumonia, thrombocytosis > 600 x 109 cells/L, nausea, and ALT ≥3 x ULN is based on the pooled rheumatoid arthritis and atopic dermatitis clinical trials. In patients treated with baricitinib in the atopic dermatitis clinical trials, the frequency of those events was uncommon.

cIncludes changes detected during laboratory monitoring.

dFrequency for acne and creatine phosphokinase increased > 5 x ULN is based on the pooled rheumatoid arthritis and atopic dermatitis clinical trials. In patients treated with baricitinib in the rheumatoid arthritis clinical trials, the frequency of those events was uncommon.

Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).4

The frequencies are based on integrated data across both rheumatoid arthritis and atopic dermatitis indications unless stated otherwise.4

Where notable differences in frequency are observed in one indication alone, these are presented in the footnotes below the table.4

Reference

1Genovese 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

2Genovese 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.

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

BARI = baricitinib

CPK = creatine phosphokinase

MTX = methotrexate

PYE = patient-years of exposure

RA = rheumatoid arthritis

Datum fӧr senaste ӧversyn 2019 M06 17


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