Taltz® (Ixekizumab)

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Ixekizumab: Concomitant Medication Use in Psoriatic Arthritis Clinical Trials

In the pivotal phase 3 trials in patients with active PsA, 62.7% of patients reported using ≥1 concomitant medication through week 24.

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Concomitant Medications Allowed in Pivotal Psoriatic Arthritis Clinical Trials

In the 2 phase 3 placebo-controlled clinical trials (SPIRIT-P1 and SPIRIT-P2) conducted in patients with active PsA, patients maintained their usual medication regimens for other concomitant diseases throughout the trials unless those medications were specifically excluded in the protocols.1,2

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.1,2

In the PsA trials, inclusion and exclusion criteria specified stable background concomitant medications for PsA (Permitted and Excluded Concomitant Medications in the Phase 3 Psoriatic Arthritis Clinical Trials SPIRIT-P1 and SPIRIT-P2). Additionally, the protocol included a requirement to add or modify these concomitant medications for inadequate responders at week 16. From week 16 through week 24, rescue medications eligible for inadequate responders were

  • cDMARDs, consisting of
    • methotrexate
    • hydroxychloroquine
    • leflunomide, and
    • sulfasalazine
  • NSAIDs including COX-2 inhibitors
  • opiate analgesics
  • oral corticosteroids, and
  • one intra-articular injection of a corticosteroid.1,2

Permitted and Excluded Concomitant Medications in the Phase 3 Psoriatic Arthritis Clinical Trials SPIRIT-P1 and SPIRIT-P2 lists concomitant medications that were specifically permitted or excluded over the course of the SPIRIT phase 3 clinical trials in patients with active PsA.

Permitted and Excluded Concomitant Medications in the Phase 3 Psoriatic Arthritis Clinical Trials SPIRIT-P1 and SPIRIT-P21,2

Permitted Concomitant Medications

No more than 1 of the following designated cDMARDs: oral or parenteral methotrexate 10-25 mg/wk, leflunomide up to 20 mg/d, sulfasalazine up to 3 g/d, and hydroxychloroquine up to 400 mg/da

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

Weak topical steroids including those from the mild class, such as desonide, and the least potent class, such as hydrocortisonea

Opiates up to 30 mg/d morphine or its equivalenta

NSAIDsa

COX-2 inhibitorsa

Analgesics

Inhaled steroids for asthma

Shampoos that do not contain more than 3% salicylic acid, corticosteroids, coal tar, or vitamin D3 analogues

Topical products that do not contain urea, more than 3% salicylic acid, α- or β-hydroxyl acids, or vitamin D3 analogues

Bath oils and oatmeal bath preparations

Excluded Concomitant Medications

All other bDMARDs

Nondesignated cDMARDsb

Topical steroids other than weak potency

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

aPatients were allowed to take stable doses without modification through the 24-week double-blind treatment period or up to week 16 if deemed to be inadequate responders.

bMethotrexate, leflunomide, sulfasalazine, and hydroxychloroquine were permitted as described.

Concomitant Medication Use in Psoriatic Arthritis Clinical Trials

Across 2 phase 3 placebo-controlled clinical trials (SPIRIT-P1 and SPIRIT-P2) conducted in patients with active PsA, 62.7% of patients reported taking at least 1 concomitant medication through week 24 of treatment.3

Most Common Concomitant Medications Reported Through Week 24 in the Phase 3 Psoriatic Arthritis Clinical Trials SPIRIT-P1 and -P2 lists concomitant medications reported in at least 1.0% of trial participants.

In addition, 64% of patients in SPIRIT-P1 and 51% of patients in SPIRIT-P2 were taking concomitant cDMARDs.1,2 Information on concomitant cDMARD use is available upon request.

Most Common Concomitant Medications Reported Through Week 24 in the Phase 3 Psoriatic Arthritis Clinical Trials SPIRIT-P1 and -P23

Concomitant Medications Reporteda

IXE and PBO Groups (N=678)

Paracetamol (acetaminophen)

55 (8.1)

Antibiotics

Amoxicillin

35 (5.2)

Azithromycin

23 (3.4)

Amoxicillin/Clavulanic acid

14 (2.0)

Levofloxacin

13 (1.9)

Cephalexin

11 (1.6)

Clarithromycin

9 (1.3)

Ciprofloxacin

8 (1.2)

Clavulanic acid

8 (1.2)

Doxycycline

8 (1.2)

Sulfamethoxazole/Trimethoprim

7 (1.0)

NSAIDs

Meloxicam

36 (5.3)

Diclofenac

30 (4.4)

Ibuprofen

25 (3.7)

Nimesulide

8 (1.2)

Corticosteroids

Prednisone

20 (2.9)

Methylprednisolone

9 (1.3)

Antihistamines

Cetirizine

19 (2.8)

Loratidine

10 (1.5)

Levocetirizine

9 (1.3)

Fexofenadine

8 (1.2)

Influenza vaccine

13 (1.9)

Folic acid

9 (1.3)

Metamizole

9 (1.3)

Silybum marianum (milk thistle)

8 (1.2)

Atorvastatin

7 (1.0)

Fluconazole

7 (1.0)

Pantoprazole

7 (1.0)

Abbreviations: cDMARD = conventional disease-modifying antirheumatic drug; IXE = ixekizumab; NSAID = nonsteroidal anti-inflammatory drug; PBO = placebo.
Note: Concomitant cDMARDs are out of scope for this table as those are being assessed separately.

aData presented as n (%).

References

1Mease PJ, van der Heijde D, Ritchlin CT, et al; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76(1):79-87. http://dx.doi.org/10.1136/annrheumdis-2016-209709

2Nash P, Kirkham B, Okada M, et al; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389(10086):2317-2327. http://dx.doi.org/10.1016/S0140-6736(17)31429-0

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

Glossary

AE = adverse event

cDMARD = conventional disease-modifying antirheumatic drug

COX-2 = cyclooxygenase 2 

NSAID = nonsteroidal anti-inflammatory drug

PsA = psoriatic arthritis

Fecha de la última revisión: 2020 M03 13


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