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Olumiant® (baricitinib): Översikt över effekt och säkerhet hos patienter med atopisk dermatit från fas 3, placebokontrollerade studier

I BREEZE-AD fas 3-programmet förbättrade baricitinib måttlig till svår atopisk dermatit med en liknande säkerhetsprofil jämfört med placebo.

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en-GB

Efficacy and Safety in Atopic Dermatitis Phase 3 Clinical Trial Program

Overview of Atopic Dermatitis Clinical Trial Program

Overview of the BREEZE-AD Phase 3 Clinical Program Study Designs

The efficacy and safety of BARI has been evaluated in the following placebo-controlled trials in adult patients with moderate to severe AD

  • BREEZE-AD1 (N=624) and BREEZE-AD2 (N=615) compared BARI 1 mg, 2 mg, or 4 mg monotherapy to placebo in adult patients with inadequate response to TCS.1
  • BREEZE-AD4 (N=500) compared BARI 1 mg, 2 mg, or 4 mg in combination with TCS vs placebo with TCS in adult patients who were inadequate responders to, intolerant of, or contraindicated for cyclosporine.2
  • BREEZE-AD5 (N=440) compared BARI 1 mg or 2 mg monotherapy to placebo in adult patients with inadequate response to TCS.3
  • BREEZE-AD7 (N=329) compared BARI 2 mg or 4 mg in combination with TCS vs placebo with TCS in adult patients with inadequate response to topical medications.4

In addition, adult patients from the placebo-controlled trials were eligible for enrollment in the following long-term extension studies

  • BREEZE-AD3 (estimated enrollment N=1760) a 104-week double-blind extension study in responders or non-responders who completed BREEZE-AD1, BREEZE-AD2 and BREEZE-AD7.
    • Non-responders in the originating study were randomized to a BARI 2 mg, or BARI 4 mg.
    • Responders remained on the assigned treatments from the originating study.
    • At week 52, all adult patients were eligible for a down-titration or withdrawal sub-study.5
  • BREEZE-AD6 (estimated enrollment N=300) a 204-week open-label extension study for nonresponders from BREEZE-AD5 who were discontinued from the trial at week 16.6

Note: BARI 1 mg was studied in pivotal trials, however it is not approved. Please refer to section 4.2 of the Olumiant Summary of Product Characteristics for approved dosage.

Primary and Key Efficacy Outcomes in the Placebo-Controlled Phase 3 Trials From the BREEZE-AD Clinical Program

Primary Outcomes

Validated Investigator's Global Assessment of Atopic Dermatitis

The vIGA-AD is a validated 5-point score using the descriptors that best describe the overall appearance of the AD lesions at a given time point.7

The BREEZE-AD1, BREEZE-AD2, and BREEZE-AD7 studies' primary efficacy outcome is the proportion of patients achieving a response of 0 or 1 (clear or almost clear) with a ≥2-point improvement on the vIGA-AD in the BARI dose group (BARI 2 mg and BARI 4 mg for BREEZE-AD1 and BREEZE-AD2; BARI 2 mg, and BARI 4 mg for BREEZE-AD7) compared with placebo at week 16.1,8-10

Eczema Area and Severity Index 75% Improvement

An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index), and improvement of 75% in that score is EASI 75.11

The BREEZE-AD4 and BREEZE-AD5 studies' primary efficacy outcome is the proportion of patients achieving EASI 75 in the BARI dose group (BARI 2 mg and BARI 4 mg for BREEZE-AD4; BARI 4 mg for BREEZE-AD5) compared with placebo at week 16.2,12,13

Secondary Efficacy Outcomes

In the placebo-controlled phase 3 BREEZE-AD clinical trials, the key secondary efficacy outcomes included

  • proportion of patients achieving EASI 90
  • EASI change from baseline,
  • Itch NRS ≥4-point from baseline
  • ADSS item 2 change from baseline
  • Skin pain NRS change from baseline
  • SCORAD change from baseline, and
  • when the endpoint was not the primary endpoint for the study
    • proportion of patients achieving a response of 0 or 1 with a ≥2-point improvement of vIGA-AD, and
    • proportion of patients achieving EASI 75.1-4,10

Additional study design details are available in the response titled: Baricitinib: Atopic Dermatitis Phase 3 Studies.

Overview of Efficacy Results From BREEZE-AD Phase 3 Placebo-Controlled Studies

Baseline Characteristics From BREEZE-AD Placebo-Controlled Clinical Studies

The BREEZE-AD phase 3 placebo-controlled clinical studies enrolled adult patients with moderate to severe AD >12 months who had inadequate response to topical medications (in the case of BREEZE-AD4 inadequate response to cyclosporine) either with BARI as monotherapy or in combination with TCS.1-4

Baseline Characteristics and Disease Activity From BREEZE-AD Placebo-Controlled Atopic Dermatitis Monotherapy Clinical Trials (BREEZE-AD1, BREEZE-AD2 and BREEZE-AD5) and Combination with TCS Clinical Trials (BREEZE-AD4 and BREEZE-AD7)1,3,4,14-16

Mean (SD) unless otherwise specified

BREEZE-AD1
N=624


BREEZE-AD2
N=615

BREEZE-AD5
N=440

BREEZE-AD4
N=463

BREEZE-AD7
N=329

Age, years

36 (13)

35 (13)

40 (16)

38 (14)

34 (12)

Female, %

37

38

49

36

34

Race

Caucasian, %

59

69

57

78

46

Asian, %

30

30

19

19

51

African American, %

0.3

NA

18

2

NA

Other, %

11

2

6

1

3

Duration since AD Diagnosis, years

26 (15)

24 (14)

24 (17)

26 (15)

24 (13)

Weight (kg)

74 (17)

73 (15)

80 (22)

76 (18)

73 (16)

BMI

25 (5)

25 (5)

28 (7)

26 (5)

25 (5)

Geographic Region

Europe, %

54

46

NA

70

35

Japan, %

18

18

NA

17

19

Other, %

28

36

Canada = 27
US = 73

13

46

Baseline Disease Activity

vIGA-AD of 3, %

58

50

58

49

55

vIGA-AD of 4, %

42

50

42

51

45

EASI

31 (12)

33 (13)

27 (11)

32 (13)

30 (12)

SCORAD

67 (14)

68 (13)

64 (13)

69 (13)

67 (14)

BSA affected

51 (22)

54 (23)

41 (23)

52 (23)

50 (23)

Itch NRS

6 (2)

7 (2)

7 (2)

7 (2)

7 (2)

Skin Pain NRSa

6 (2)

6 (3)

7 (2)

6 (3)

6 (2)

ADSS item 2

3 (5)

2 (2)

2 (3)

2 (3)

2 (2)

Abbreviations: AD = atopic dermatitis; ADSS = atopic dermatitis sleep scale; BMI = body mass index; BSA = body surface area; EASI = Eczema Area Severity Index; NRS = Numeric Rating Scale; NA = not applicable; SCORAD = SCORing Atopic Dermatitis; TCS = topical corticosteroid; United States; vIGA-AD = Validated Investigator's Global Assessment of atopic dermatitis.

Atopic dermatitis sleep scale item 2 asked: “How many times did your itch cause you to wake up last night?”

aPain includes discomfort and soreness.

Overview of Primary Efficacy Results From the Phase 3, Placebo-Controlled Studies in the BREEZE-AD Clinical Program

Monotherapy Clinical Trials

BREEZE-AD1 and BREEZE-AD2

In BREEZE-AD1 and BREEZE-AD2 phase 3 trial, the primary endpoint of a higher proportion of patients achieving vIGA-AD (0 or 1) at week 16 when treated with BARI compared to placebo was met.1

In BREEZE-AD1, compared to placebo (4.8%), the proportion of patients who achieved a vIGA-AD of 0 or 1 with a ≥2-point improvement from baseline to week 16 was statistically significant in the

In BREEZE-AD2, compared to placebo (4.5%), a statistically significantly higher patients achieved an vIGA-AD of 0 or 1 with a ≥2-point improvement from baseline in the

  • BARI 4-mg group (13.8%; p≤.01), and
  • BARI 2-mg group (10.6%; p≤.05).1

Baricitinib 1 mg result (8.8%) was not statistically significant compared to placebo.

BREEZE-AD1 and BREEZE-AD2 Investigator's Global Assessment 0 or 1 Response Rates at Week 161

Abbreviations: AD = atopic dermatitis; BARI = baricitinib; ITT = intent to treat; NRI = non-responder imputation; PBO = placebo; TCS = topical corticosteroid.

Primary censoring censored data after rescue with TCS or permanent discontinuation of study drug and is representative of monotherapy. Data are ITT and NRI.

* p≤.05 vs placebo.

** p≤.01 vs placebo.

*** p≤.001 vs placebo.

BREEZE-AD5

In BREEZE-AD5 trial, the primary endpoint of patients achieving at least a 75% or greater change from baseline in their EASI at week 16 when treated with BARI compared to placebo was met.3

As seen inBREEZE-AD5 Percent of Patients Achieving EASI 75 Response at Week 16, compared to placebo (8.2%), a statistically significant higher proportion of patients achieved an EASI 75 in the BARI 2-mg group (29.5%; p≤.001), but not in the BARI 1-mg group (12.9%) at week 16.3

BREEZE-AD5 Percent of Patients Achieving EASI 75 Response at Week 163

Abbreviations: AD = atopic dermatitis; BARI = baricitinib; EASI = Eczema Area and Severity Index; EASI 75 = Eczema Area and Severity Index 75% improvement; ITT = intent to treat; MMRM = mixed model repeated measures; NRI = nonresponder imputation; TCS = topical corticosteroid.

Primary censoring censored data after rescue with TCS or permanent discontinuation of study drug and is representative of monotherapy. Data are ITT and NRI. 
* p≤.05.
** p≤.01.
*** p≤.001 versus placebo (by logistic regression analysis, NRI and MMRM for EASI).

Combination With Topical Corticosteroid Clinical Trials

BREEZE-AD7

In BREEZE-AD7 trial, the primary endpoint of a higher proportion of patients achieving vIGA-AD (0 or 1) at week 16 when treated with BARI in combination with TCS compared to placebo was met.4

In BREEZE-AD7, compared to the placebo + TCS group (14.7%), the proportion of patients who achieved an vIGA-AD of 0 or 1 with a ≥2-point improvement from baseline at week 16 was

BREEZE-AD7 Investigator's Global Assessment 0 or 1 Response Rates at Week 1615

Abbreviations: AD = atopic dermatitis; BARI = baricitinib; ITT = intent to treat; NRI = non-responder imputation; PBO = placebo; TCS = topical corticosteroid; vIGA-AD = Validated Investigator's Global Assessment of atopic dermatitis.

BREEZE-AD7 primary endpoint was the proportion of patients at week 16 who achieved an vIGA-AD of 0 or 1. Primary censoring censored data after permanent discontinuation of study drug. Data are ITT and NRI.

** p≤.01 vs placebo.

BREEZE-AD4

In BREEZE-AD4 phase 3 trial, the primary endpoint of patients achieving at least a 75% or greater change from baseline in their EASI at week 16 when treated with BARI in combination with TCS compared to placebo was met in adult patients with moderate to severe AD who were inadequate responders, intolerant or had contraindication to treatment with cyclosporine. 

In BREEZE-AD4, compared to placebo (17.2%), a statistically significant higher proportion of patients achieved an EASI 75 in the BARI 4-mg in combination with TCS group (31.5%; p≤.05), but not BARI 2 mg in combination with TCS (27.6%) and BARI 1-mg group (22.6%) at week 16 as seen in BREEZE-AD4 Proportion of Patients Achieving at Least a 75% or Greater Change From Baseline in Their EASI at Week 16.

BREEZE-AD4 Proportion of Patients Achieving at Least a 75% or Greater Change From Baseline in Their EASI at Week 16

Abbreviations: AD = atopic dermatitis; BARI = baricitinib; EASI = Eczema Area and Severity Index; ITT = intent to treat; NRI = non-responder imputation; PBO = placebo; TCS = topical corticosteroids.

Primary censoring censored data after permanent discontinuation of study drug. Data are ITT and NRI.

* p≤.05.
** p≤.01.
*** p≤.001 for analyses comparing BARI with PBO.

Overview of Secondary Efficacy Results From the Phase 3, Placebo-Controlled Studies in the BREEZE-AD Clinical Program

In BREEZE-AD1 and BREEZE-AD2, compared to placebo, patients with moderate to severe AD who were treated with monotherapy BARI 4 mg had statistically significant (p≤.05) greater improvements at week 16 in

  • key secondary efficacy measures including
    • proportion of patients achieving EASI 90
    • change from baseline EASI score
    • proportion of patients achieving SCORAD 75
    • ≥4-point improvement Itch NRS
    • change in item 2 of the ADSS (number of nighttime awakenings due to itch)
    • change in skin pain NRS, and
    • proportion of patients achieving EASI 75.1

In BREEZE-AD2 and BREEZE-AD5, compared to placebo, patients with moderate to severe AD who were treated with monotherapy BARI 2 mg had statistically significant (p≤.05) greater improvements at week 16 in

  • key secondary efficacy measures including
    • proportion of patients achieving EASI 90
    • change from baseline EASI score
    • proportion of patients achieving SCORAD 75
    • ≥4-point improvement Itch NRS
    • change in item 2 of the ADSS (number of nighttime awakenings)
    • change in skin pain NRS, and
    • when the endpoint was not the primary endpoint for the study
      • proportion of patients achieving a response of 0 or 1 with a ≥2-point improvement of vIGA-AD (BREEZE-AD5), and
      • proportion of patients achieving EASI 75 (BREEZE-AD2).1,3

In BREEZE-AD7, compared to placebo, patients with moderate to severe AD who were treated with BARI 4 mg in combination with TCS had statistically significant (p≤.05) greater improvements compared to placebo in combination with TCS at week 16 in

  • key secondary efficacy measures including
    • proportion of patients achieving EASI 90
    • change from baseline EASI score
    • proportion of patients achieving SCORAD 75
    • ≥4-point improvement Itch NRS
    • change in item 2 of the ADSS
    • change in skin pain NRS, and
    • proportion of patients achieving EASI 75.4,14,15

In BREEZE-AD4, compared to placebo, patients with moderate to severe AD who were inadequate responders, intolerant or had contraindication to treatment with cyclosporine treated with BARI 4 mg in combination with TCS had statistically significant (p≤.05) greater improvements compared to placebo in combination with TCS at week 16 in

  • key secondary efficacy measures including
    • change from baseline EASI score
    • ≥4-point improvement Itch NRS
    • change in item 2 of the ADSS
    • change in skin pain NRS, and
    • proportion of patients achieving a response of 0 or 1 with a ≥2-point improvement of vIGA-AD.14

A summary of the clinical efficacy endpoints and patient reported outcomes are presented hereSummary of Clinical Efficacy Endpoints and Patient Reported Outcomes in the BREEZE Clinical Trial Program.

Summary of Clinical Efficacy Endpoints and Patient Reported Outcomes in the BREEZE Clinical Trial Program14

Study and Treatment

vIGA-AD, n (%)

EASI 75, n (%)

EASI 50, n (%)

EASI 90, n (%)

% change in total EASI score, 0-16 weeks

SCORAD 75, n (%)

≥4-point improvement in Itch NRS at week 16, n (%)

Change in Item 2 of the ADSS, 0-16 weeks, change from baselinea

Change in Skin Pain NRS, 0-16 weeks, change from baselinea

Monotherapy Clinical Trials

BREEZE-AD1 N=624

Placebo N=249

12 (4.8)

22 (8.8)

38 (15.3%)

12 (4.8)

-35

3 (1.2)

16 (7.2)

-0.84

-0.84

BARI 1 mg N=127

15 (11.8)b

22 (17.3)

33 (26.0%)b

11 (8.7)

-48b

7 (5.5)b

11 (10.5)

-1.21 (-0.82, 0.08)

-1.92 (-1.84, -0.32)c

BARI 2 mg N=123

14 (11.4)b

23 (18.7)c

37 (30.1%)d

13 (10.6)b

-52c

9 (7.3)c

12 (12.0)

-1.04 (-0.65, 0.23)

-1.58 (-1.48, 0.00)

BARI 4 mg N=125

21 (16.8)d

31 (24.8)d

52 (41.6%) d

20 (16.0)d

-59d

13 (10.4)d

23 (21.5)d

-1.42 (-1.0, -0.17)c

-1.93 (-1.79, -0.39)c

BREEZE-AD2 N=615

Placebo N=244

11 (4.5)

15 (6.1)

30 (12.3%)

6 (2.5)

-29

4 (1.6)

10 (4.7)

-0.5

-0.86

BARI 1 mg N=125

11 (8.8)

16 (12.8)b

23 (18.4%)

8 (6.4)

-42

6 (4.8)

6 (6.0)

-0.78 (-0.64, 0.08)

-1.09 (-1.05, 0.59)

BARI 2 mg N=123

13 (10.6)b

22 (17.9)d

34 (27.6%) d

11 (8.9)c

-55d

9 (7.3)c

16 (15.1)c

-1.03 (-0.88, -0.18)c

-2.61 (-2.54, -0.96)d

BARI 4 mg N=123

17 (13.8)d

26 (21.1)d

36 (29.3%) d

16 (13.0)d

-55d

14 (11.4)d

20 (18.7)d

-1.13 (-0.96, -0.29)d

-2.49 (-2.37, -0.87)d

BREEZE-AD5 N=440

Placebo N=147

8 (5.4)

12 (8.2)

19 (12.9)

5 (3.4)

-34

4 (2.7)

7 (5.7)

-0.40

-1.03

BARI 1 mg N=147

19 (12.9)b

19 (12.9)

29 (19.7)

11 (7.5)

-47

5 (3.4)

21 (15.9)b

-0.62 (-0.75, 0.32)

-2.16 (-1.99, -0.25)b

BARI 2 mg N=146

35 (24.0)d

43 (29.5)d

51 (34.9) d

30 (20.5)d

-54c

21 (14.4)c

33 (25.2)d

-0.99 (-1.12, -0.06)b

-2.40 (-2.22, -0.51)c

Combination with TCS Clinical Trials

BREEZE-AD4 N=463

Placebo N=93

9 (9.7)

16 (17.2)

33 (35.5)

6 (6.5)

-43

1 (1.1)

7 (8.2)

-0.63

-1.56

BARI 1 mg N=93

12 (12.9)

21 (22.6)

42 (45.2)

8 (8.6)

-60c

6 (6.5)

18 (23.1)b

-1.05 (-0.82, -0.02)b

-2.27 (-1.47, 0.06)

BARI 2 mg N=185

28 (15.1)

51 (27.6)

95 (51.4) b

19 (10.3)

-56c

15 (8.1)b

38 (22.9)c

-0.85 (-0.56, 0.13)

-2.40 (-1.50, -0.17)b

BARI 4 mg N=92

20 (21.7)b

29 (31.5)b

48 (52.2) b

13 (14.1)

-63d

6 (6.5)

29 (38.2)d

-1.42 (-1.18, -0.39)d

-3.02 (-2.21, -0.69)d

BREEZE-AD7 N=329

Placebo N=109

16 (14.7)

25 (22.9)

45 (41.3%)

15 (13.8)

-45

8 (7.3)

21 (20.2)

-0.51

-2.06

BARI 2 mg N=109

26 (23.9)

47 (43.1)c

70 (64.2%)d

18 (16.5)

-58b

12 (11.0)

37 (38.1)c

-1.33 (-1.23, -0.41)d

-3.22 (-1.78, -0.52)d

BARI 4 mg N=111

34 (30.6)c

53 (47.7)d

78 (70.3%)d

27 (24.3)b

-67d

20 (18.0)b

44 (44.0)d

-1.42 (-1.33, -0.51)d

-3.73 (-2.30, -1.03)d

Abbreviations: AD = atopic dermatitis; ADSS = Atopic Dermatitis Sleep Scale; BARI = baricitinib; EASI = Eczema Area and Severity Index; EASI 50 = Eczema Area and Severity Index 50% improvement;  EASI 75 = Eczema Area and Severity Index 75% improvement; EASI 90 = Eczema Area and Severity Index 90% improvement; vIGA-AD = Validated Investigator's Global Assessment of atopic dermatitis; NRS = numeric rating scale; SCORAD = SCORing Atopic Dermatitis; TCS = topical corticosteroid.

Atopic Dermatitis Sleep Scale Item 2 asked: “How many times did your itch cause you to wake up last night?”

aLeast square means and 95% confidence interval; placebo does not have a confidence interval.

bp<.05.

cp<.01.

dp<.001.

Safety Results Across the Phase 3, Placebo-Controlled Studies in the BREEZE-AD Clinical Program

Summary of Clinically Important Measures of Safety Through Week 16 provides a summary of clinically relevant measures of tolerability including event rates across treatment groups for adverse events leading to discontinuation of study treatment through 16 weeks.

Summary of Clinically Important Measures of Safety Through Week 161,3,4,14

Study and Treatment

TEAEs

AE Interrupted Treatment

AE Led to Discontinuation

SAEs

Death

Monotherapy Clinical Trials

BREEZE-AD1 N=624

Placebo N=249

135 (54)

3 (1)

4 (2)

6 (2)

0

BARI 1 mg N=127

69 (54)

3 (2)

2 (2)

1(1)

0

BARI 2 mg N=123

71 (58)

4 (3)

1 (1)

0

0

BARI 4 mg N=125

73 (58)

8 (6)

1 (1)

2 (2)

0

BREEZE-AD2 N=615

Placebo N=244

137 (56)

5 (2.0)

2 (1)

9 (4)

0

BARI 1 mg N=125

66 (53)

5 (4.0)

7 (6)

9 (7)

0

BARI 2 mg N=123

71 (58)

3 (2.4)

3 (2)

3 (2)

0

BARI 4 mg N=123

66 (54)

3 (2.4)

2 (2)

1 (1)

0

BREEZE-AD5 N=440

Placebo N=147

72 (49)

4 (2.7)

4 (2.7)

3 (2.1)

0

BARI 1 mg N=147

79 (54)

3 (2.0)

4 (2.7)

1 (0.7)

0

BARI 2 mg N=146

74 (51)

1 (0.7)

4 (2.8)

2 (1.4)

0

Combination with TCS Clinical Trials

BREEZE-AD4 N=463

Placebo N=93

50 (54)

1 (1.1)

1 (1.1)

2 (2.2)

0

BARI 1 mg N=93

58 (62)

6 (6.5)

0

4 (4.3)

0

BARI 2 mg N=185

125 (68)

16 (8.7)

3 (1.6)

3 (1.6)

0

BARI 4 mg N=92

69 (75)

10 (10.9)

1 (1.1)

6 (6.5)

0

BREEZE-AD7 N=329

Placebo N=108

41 (38)

5 (4.6)

0

4 (3.7)

0

BARI 2 mg N=109

61 (56)

4 (3.7)

1 (0.9)

2 (1.8)

0

BARI 4 mg N=111

64 (58)

5 (4.5)

3 (2.7)

4 (3.6)

0

Abbreviations: AD = atopic dermatitis; AE = adverse event; BARI = baricitinib; SAEs = serious adverse events; TCS = topical corticosteroid; TEAE = treatment-emergent adverse event.

References

1Simpson EL, Lacour JP, Spelman L, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials. Br J Dermatol. 2020;183(2):242-255. http://dx.doi.org/10.1111/bjd.18898

2A long-term study of baricitinib (LY3009104) with topical corticosteroids in adults with moderate to severe atopic dermatitis that are not controlled with cyclosporine or for those who cannot take oral cyclosporine because it is not medically advisable (BREEZE-AD4). ClinicalTrials.gov identifier: NCT03428100. Updated January 3, 2020. Accessed September 16, 2020. https://clinicaltrials.gov/ct2/show/NCT03428100

3Simpson E, Forman S, Silverberg J, et al. Efficacy and safety of baricitinib in moderate-to-severe atopic dermatitis: results from a randomized, double-blinded, placebo-controlled phase 3 clinical trial (BREEZE-AD5). Abstract presented at: Revolutionizing Atopic Dermatitis (RAD) Virtual Symposium; April 5, 2020. Accessed April 5, 2020.

4Reich K, Kabashima K, Peris K, et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in moderate to severe atopic dermatitis: results of a phase 3 randomized, double-blind, placebo-controlled 16-week trial (BREEZE-AD7). Abstract presented at: European Academy of Dermatology and Venereology 28th Congress; October 9-13, 2019; Madrid, Spain.

5A study of long-term baricitinib (LY3009104) therapy in atopic dermatitis (BREEZE-AD3). ClinicalTrials.gov identifier: NCT03334435. Updated March 17, 2020. Accessed September 16, 2020. https://clinicaltrials.gov/ct2/show/NCT03334435

6A study of baricitinib (LY3009104) in participants with moderate to severe atopic dermatitis (BREEZE-AD6). ClinicalTrials.gov identifier: NCT03559270. Updated September 4, 2020. Accessed September 16, 2020. https://clinicaltrials.gov/ct2/show/NCT03559270

7Simpson E, Bissonnette R, Eichenfield L, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis. [published online April 25, 2020]. J Amer Acad Dermatol. http://dx.doi.org/10.1016/j.jaad.2020.04.104

8A study of baricitinib (LY3009104) in adults with moderate to severe atopic dermatitis (BREEZE-AD1). ClinicalTrials.gov identifier: NCT03334396. Updated January 18, 2020. Accessed February 4, 2020. https://clinicaltrials.gov/ct2/show/NCT03334396

9Study of baricitinib (LY3009104) in adults with moderate to severe atopic dermatitis (BREEZE-AD2). ClinicalTrials.gov identifier: NCT03334422. Updated January 22, 2020. Accessed February 4, 2020. https://clinicaltrials.gov/ct2/show/NCT03334422

10A study of baricitinib (LY3009104) in combination with topical corticosteroids in adults with moderate to severe atopic dermatitis (BREEZE-AD7). ClinicalTrials.gov identifier: NCT03733301. Updated September 23, 2019. Accessed October 10, 2019. https://clinicaltrials.gov/ct2/show/NCT03733301

11Hanifin JM, Thurston M, Omoto M, et al. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001;10(1):11-18. http://dx.doi.org/10.1034/j.1600-0625.2001.100102.x

12A study of baricitinib (LY3009104) in adult participants with moderate to severe atopic dermatitis (BREEZE-AD5). ClinicalTrials.gov identifier: NCT03435081. Updated January 3, 2020. Accessed January 3, 2020. https://clinicaltrials.gov/ct2/show/NCT03435081

13A phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of baricitinib in combination with topical corticosteroids in adult patients with moderate-to-severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to, cyclosporine. ClinicalTrialsRegister.eu identifier: EudraCT 2017-004574-34/GB. Posted March 29, 2018. Accessed April 13, 2020. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-004574-34/GB

14Data on file, Eli Lilly and Company and/or one of its subsidiaries.

15Reich K, Kabashima K, Peris K, et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in moderate to severe atopic dermatitis: results of a phase 3 randomized, double-blind, placebo-controlled 16-week trial (BREEZE-AD7) [abstract]. European Academy of Dermatology 28th Congress; October 9-13, 2019; Madrid, Spain.

16Simpson, EL, Lacour J, Spelman L, et al. Efficacy and safety of baricitinib in moderate to severe atopic dermatitis: results of two phase 3 monotherapy randomized, double-blind, placebo-controlled 16-week trials (BREEZE-AD1 and BREEZE-AD2). Presented as an oral presentation at: World Congress of Dermatology; June 10-15, 2019; Milan, Italy.

Glossary

AD = atopic dermatitis

ADSS = Atopic Dermatitis Sleep Scale

BARI = baricitinib

BSA = body surface area

EASI = Eczema Area and Severity Index

EASI 75 = Eczema Area and Severity Index 75% improvement

SCORAD = SCORing Atopic Dermatitis

TCS = topical corticosteroids

vIGA-AD = Validated Investigator's Global Assessment of Atopic Dermatitis

Datum fӧr senaste ӧversyn 2020 M01 24


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