Taltz ® (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Taltz Summary of Product Characteristics (SmPC)

Taltz® (ixekizumab): Which concomitant medications were used in Axial Spondyloarthritis clinical trials?

In the pivotal phase 3 trials in AS/r-axSpA, 97.2% of patients reported using ≥1 concomitant medication through week 16.

Concomitant Medications Allowed in Axial Spondyloarthritis Clinical Trials

In the clinical trials conducted in patients with AS/r-axSpA and nr-axSpA (COAST-V, -W, and -X), patients maintained their usual medication regimens for other concomitant diseases throughout the trials unless those medications were specifically excluded in the protocols.1

Patients who took concomitant medications were on stable doses at baseline and remained at a stable dose throughout the trials, unless changes were made for an AE, appropriate medical management, or as specified in the clinical trial protocol.1 

Table 1 lists concomitant medications that were specifically permitted or excluded over the course of the COAST phase 3 clinical trials in patients with AS/r-axSpA and nr-axSpA.

 

Table 1. Permitted and Excluded Concomitant Medications in the Phase 3 Ankylosing Spondylitis/Radiographic Axial Spondyloarthritis and Nonradiographic Axial Spondyloarthritis Clinical Trials COAST-V, COAST-W, and COAST-X2-4

Permitted Concomitant Medications

No more than 1 of the following designated cDMARDs: oral or parenteral methotrexate up to 25 mg/wk, sulfasalazine up to 3 g/d, or hydroxychloroquine up to 400 mg/d

Oral corticosteroids up to 10 mg/d prednisone or its equivalenta

NSAIDsb

COX-2 inhibitorsb

Opiate analgesics at average daily doses up to 30 mg/d of morphine or its equivalentc

Oral glucocorticoids up to 10 mg/da

Excluded Concomitant Medications

Denosumab

Gold salts

Cyclosporine

Azathioprine

Dapsone

6-Mercaptopurine

Mycophenolate mofetil

All other bDMARDs

Abbreviations: bDMARD = biologic disease-modifying antirheumatic drug; cDMARD = conventional disease-modifying antirheumatic drug; COX-2 = cyclooxygenase 2; NSAID = nonsteroidal anti-inflammatory drug.

a The dose must have been stable for at least 4 weeks prior to baseline randomization.

b The dose must have been stable for at least 2 weeks prior to baseline randomization.

c The dose must have been stable for at least 6 weeks prior to baseline randomization.

Concomitant Medication Use in Axial Spondyloarthritis Clinical Trials

Note: The dosing schedule IXEQ2W is not consistent with the approved dosing schedule for axial spondyloarthritis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing.5

Concomitant Medication Use in Ankylosing Spondylitis/Radiographic Axial Spondyloarthritis Clinical Trials

Across 2 phase 3 placebo-controlled clinical trials (COAST-V and COAST-W) conducted in patients with active AS/r-axSpA, 97.2% of patients reported taking at least 1 concomitant medication through week 16 of treatment.1

Table 2 shows the numbers of patients who were taking concomitant NSAIDs, glucocorticoids, or opioid analgesics at baseline in COAST-V and COAST-W.

In addition, 37% of patients in COAST-V and 27% of patients in COAST-W were taking concomitant cDMARDs (not included in table).1

Table 2. Concomitant Use of Medications at Baseline in COAST-V and COAST-W1-3


COAST-V

COAST-V

COAST-V

COAST-V

COAST-W

COAST-W

COAST-W

Concomitant Medications Reported at Baseline a

PBO (N=87)

ADA Q2W (N=90)

IXE Q2W (N=83)

IXE Q4W (N=81)

PBO (N=104)

IXE Q2W (N=98)

IXE Q4W (N=114)

NSAIDs

78 (91)

83 (92)

79 (95)

72 (89)

84 (81)

71 (72)

86 (75)

Glucocorticoids

7 (8)

12 (13)

8 (10)

13 (16)

17 (16)

12 (12)

15 (13)

Opioid analgesics

8 (9)

10 (11)

9 (11)

7 (9)

31 (30)

23 (24)

27 (24)

Abbreviations: ADA = adalimumab 40 mg every 2 weeks; cDMARD = conventional disease-modifying antirheumatic drug; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; NSAID = nonsteroidal anti-inflammatory drug; PBO = placebo.

a Data are presented as n (%).

Concomitant Medication Use in the Nonradiographic Axial Spondyloarthritis Clinical Trial 

In the phase 3 COAST-X trial conducted in patients with active nr-axSpA, 97.9% of patients reported taking at least 1 concomitant medication through week 16 of treatment.1

Table 3 shows the numbers of patients who were taking concomitant NSAIDs or glucocorticoids at baseline in COAST-X.

In addition, 40% of patients in COAST-X were taking concomitant cDMARDs (not included in table).1

Table 3. Concomitant Use of Medications at Baseline in COAST-X4

Concomitant Medications Reported at Baselinea

PBO (N=105)

IXE Q4W (N=96)

IXE Q2W (N=102)

NSAIDs

96 (91)

81 (84)

95 (93)

Glucocorticoids

14 (13)

8 (8)

20 (20)

Abbreviations: cDMARDs = conventional disease-modifying antirheumatic drugs; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo; NSAIDs = nonsteroidal anti-inflammatory drugs.

a Data are presented as n (%).

References

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

2. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al; COAST-W Study Group. 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. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al; COAST-V Study Group. 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

4. Deodhar A, van der Heijde D, Gensler LS, et al; COAST-X Study Group. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020;395(10217):53-64. http://dx.doi.org/10.1016/S0140-6736(19)32971-X

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

Glossary

AE = adverse event

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

cDMARD = conventional disease-modifying antirheumatic drug

nr-axSpA = nonradiographic axial spondyloarthritis

Date of Last Review: March 13, 2020


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