Taltz® (ixekizumab): Samtidig användning av biologiska läkemedel vid psoriasis och psoriasisartrit i kliniska prövningar

Clinical Trial Information

Combination of ixekizumab with other biologic treatments has not been studied by Lilly.

Washout Periods and Exclusion Criteria in Psoriasis Clinical Trials

In plaque psoriasis studies, the safety of ixekizumab in combination with other immunomodulatory agents or phototherapy has not been evaluated.¹

In ixekizumab PsO clinical trials, patients were required to undergo a washout period (range 3-6 half-lives) of any previous biologic agent prior to study baseline.^2,3 In the UNCOVER-2 phase 3 clinical trial, patients who were nonresponders (sPGA >1) to etanercept at week 12 switched to ixekizumab, but were required to first undergo a washout period of at least 5 half-lives (>21.5 days).⁴

Washout Periods and Exclusion Criteria in Psoriatic Arthritis Clinical Trials

No interaction was seen when ixekizumab was administered concomitantly with methotrexate (MTX) and/or corticosteroids in patients with psoriatic arthritis.¹

Patients were excluded from SPIRIT-P1 if they had any history of biologic treatment for plaque PsO or PsA.⁵ Patients were excluded from SPIRIT-P2 if they had concurrent or recent use of any biologic agent within

• 28 days for entanercept

• 60 days for infliximab, adalimumab, certolizumab pegol, or alefacept

• 90 days for golimumab

• 12 months for rituximab, or

• 5 half-lives prior to baseline (week 0; visit 2) for any other biologic agent or small molecule.⁶

Clinical Trial Overview

• UNCOVER-1, -2, and -3 (N=3866) phase 3 trials in moderate-to-severe plaque psoriasis were integrated to evaluate the safety of ixekizumab in comparison to placebo up to 12 weeks after treatment initiation. The phase 3 trials examined the efficacy and safety of ixekizumab compared with placebo and etanercept (UNCOVER-2 and -3) during induction treatment and vs placebo in maintenance (UNCOVER-1 and -2).⁷

• SPIRIT-P1 is a phase 3, 24-week double-blind, placebo and active-controlled trial in patients with active PsA who are naïve to bDMARDs, with an extension period of up to 3 years.⁵

• SPIRIT-P2 is a phase 3, 24-week double-blind, placebo-controlled trial in patients with active PsA and an inadequate response or intolerance to TNFi, with an extension period of up to 3 years.⁶

Therapeutic Indications

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.¹

Ixekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.¹

References

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

2. Gordon K, Blauvelt A, Langley RG, et al. Ixekizumab for treatment of moderate-to-severe plaque psoriasis: 12-week results from a phase 3 study (UNCOVER-1). Poster presented at: 23rd World Congress of Dermatology; June 8-13, 2015; Vancouver, Canada.

3. Griffiths CE, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomized trials. Lancet. 2015;386(9993):541-551. http://dx.doi.org/10.1016/S0140-6736(15)60125-8

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

5. Mease PJ, van der Heijde D, Ritchlin CT, et al. 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

6. Nash P, Kirkham B, Okada M, et al. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomized, 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

7. Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375:345-356. http://dx.doi.org/10.1056/NEJMoa1512711

Glossary

Lilly = Eli Lilly and Company

PsA = psoriatic arthritis

PsO = psoriasis

sPGA = static Physician Global Assessment

TNF = tumor necrosis factor