Taltz ® (ixekizumab) injektion

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Taltz® (ixekizumab): Hur många patienter avbröt studier av ankyloserande spondylit/radiografisk axiell spondyloartrit på grund av en biverkning?

Bland patienter som fick ixekizumab i AS/r-axSpA-studierna avbröt 38 (5,9%) på grund av biverkning.

Information from Phase 3 Clinical Trials

Clinical Trials Description

  • COAST-V (N=341) is a phase 3, 16-week double-blind, placebo-controlled trial with an active reference arm and an extension period to 52 weeks in patients with active AS/r-axSpA who are naive to bDMARDs.1

  • COAST-W (N=316) is a phase 3, 16-week double-blind, placebo-controlled trial with an extension period to 52 weeks in patients with active AS/r-axSpA and an inadequate response or intolerance to 1 or 2 TNF inhibitors.2

Note that multiple, different dosing regimens, including unapproved doses, are included in this response. Please refer to the Taltz Summary of Product Characteristics for approved dosing.3

Discontinuations in COAST-V

Reported reasons for discontinuation of patients randomized to treatment in COAST-V through week 16 is shown in Table 1.

Table 1. Reason for Discontinuation Through Week 16 of COAST-V1

Reason for Discontinuation, n

PBO
N=87

ADA Q2W
N=90

IXE Q2W
N=83

IXE Q4W
N=81

Adverse event

0

1a

3b

0

Lack of efficacy

0

0

0

1

Withdrawal by participant

0

1

1

2

Excluded due to allocation error

1

0

0

0

Abbreviations: ADA Q2W = adalimumab 40 mg every 2 weeks; PBO = placebo; IXE Q2W = ixekizumab 80 mg every 2 weeks after a 160 mg or 80 mg starting dose; IXE Q4W = ixekizumab 80 mg every 4 weeks after a 160 mg or 80 mg starting dose.

a Injection site reaction.

b Infectious diarrhea, n=1; injection site reaction, n=2.

Discontinuations in COAST-W

Reported reasons for discontinuation of patients randomized to treatment in COAST-W through week 16 is shown in Table 2.

Table 2. Reason for Discontinuation Through Week 16 of COAST-W2

Reason for Discontinuation, n 

PBO
N=104

IXE Q2W
N=98

IXE Q4W
N=114

Adverse event

2

2

9

Lack of efficacy

2

1

1

Deatha

0

1

0

Subject decision

7

4

3

Physician decision

0

0

1

Lost to follow-up

0

0

1

Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks after a 160 mg or 80 mg starting dose; IXE Q4W = ixekizumab 80 mg every 4 weeks after a 160 mg or 80 mg starting dose; PBO = placebo.

a Cause of death was suicide. The event was judged by the blinded principal investigator to be unrelated to the investigational product. The patient had a documented prior history of depression of about 1 year (reported as mild at study entry).

Adverse events leading to discontinuation are listed in Table 3.

Table 3. Adverse Events Leading to Discontinuation in COAST-W Through Week 162

Adverse Event, n (%)

PBO
N=104

IXE Q2W
N=98

IXE Q4W
N=114

Completed suicide

0

1 (1.0)

0

Injection site reaction

0

1 (1.0)

0

Rash generalized

0

1 (1.0)

0

Acute promyelocytic leukemia

0

0

1 (0.9)

Anemia

0

0

1 (0.9)

Colitis

0

0

1 (0.9)

Colitis ulcerative

0

0

1 (0.9)

Crohn's Disease

0

0

1 (0.9)

Diverticulitis

0

0

1 (0.9)a

Injection site pain

0

0

1 (0.9)

Peritonitis

0

0

1 (0.9)

Splenomegaly

0

0

1 (0.9)

Subileus

0

0

1 (0.9)

Arthritis

1 (1.0)

0

0

Vasculitis

1 (1.0)

0

0

Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks after a 160 mg or 80 mg starting dose; IXE Q4W = ixekizumab 80 mg every 4 weeks after a 160 mg or 80 mg starting dose; PBO = placebo.

a Adverse event was reported during blinded treatment period but patient did not discontinue until extension period.

Integrated Analysis of COAST-V and COAST-W

In an integrated analysis of data from COAST-V and COAST-W trials, among all ixekizumab exposures in AS/r-axSpA (N=641; 749.6 PYs), 38 patients (5.9%; IR=5.1 per 100 PY) discontinued from the study due to an AE as of September 20, 2018, (see Table 4).4

One discontinuation was due to completed suicide in a patient with a documented history of depression, reported as mild at study entry, for about 1 year. The blinded principal investigator judged the event as unrelated to the investigational product.2

Table 4. Discontinuations Due to an Adverse Event in the COAST-V and COAST-W Clinical Trials4,5

System Organ Class

Frequency
N=641 (749.6 PYs)

Infections and infestations, n (%)a

8 (1.2)

Gastrointestinal disorders, n (%)b

8 (1.2)

General disorders and administration site conditions, (%)c

5 (0.8)

Musculoskeletal and connective tissue disorders, n (%)d

4 (0.6)

Skin and subcutaneous tissue disorders, n (%)e

4 (0.6)

Neoplasms benign, malignant, and unspecified, n (%)f

3 (0.5)

Blood and lymphatic system disorders, n (%)g

2 (0.3)

Eye disorders, n (%)h

2 (0.3)

Injury, poisoning, and procedural complications, n (%)i

1 (0.2)

Psychiatric disorders, n (%)j

1 (0.2)

Total, n (%)

38 (5.9%)

a Includes 1 case each of cellulitis, conjunctivitis, infectious diarrhea, diverticulitis, infected eczema, esophageal candidiasis, peritonitis, and pustular rash.

b Includes 2 cases each of ulcerative colitis and Crohn's disease, and 1 case each of abdominal pain, colitis, ulcerative proctitis, and subileus.

c Includes 4 cases of injection site reaction and 1 case of injection site pain.

d Includes 1 case each of ankylosing spondylitis, axial spondyloarthritis, back pain, and osteoarthritis.

e Includes 1 case each of alopecia, allergic dermatitis, pemphigus, and generalized rash.

f Includes 1 case each of ovarian cancer, acute promyelocytic leukemia, and bladder cancer.

g Includes 1 case each of anemia and splenomegaly.

h Iridocyclitis.

i Cervical vertebral fracture.

j Completed suicide.

References

1. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392(10163):2441-2451. http://dx.doi.org/10.1016/s0140-6736(18)31946-9

2. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71(4):599-611. http://dx.doi.org/10.1002/art.40753

3. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

4. Marzo-Ortega H, Mysler E, Tomita T, et al. Long-term safety of ixekizumab in patients with radiographic axial spondyloarthritis/ankylosing spondylitis: an integrated safety analysis of COAST-V and COAST-W [abstract]. Ann Rheum Dis. 2019;78(suppl 2):A885. http://scientific.sparx-ip.net/archiveeular/?c=a&searchfor=ixekizumab&view=2&item=2019FRI0400

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

Glossary

AE = adverse event

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

bDMARD = biologic disease-modifying antirheumatic drug

PY = patient-years

Q2W = every 2 weeks

Q4W = every 4 weeks

TNF = tumor necrosis factor

Datum fӧr senaste ӧversyn 2019 M06 27


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