Taltz ® (ixekizumab) injection

80 mg/mL

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

How to switch to TALTZ® (ixekizumab) from a different biologic for psoriasis?

Specific recommendations on switching from another biologic therapy to ixekizumab are not available. Washout periods were required in clinical trials.

Treatment Guidelines on Biologic Switching

  • The Joint American Academy of Dermatology and National Psoriasis Foundation 2019 guidelines on the treatment and management of psoriasis with biologics states no evidence-based studies have been conducted to determine the appropriate duration of time between discontinuation of the previous medication and initiation of a biologic. The guidelines suggest assessments should be done on a case-by-case basis considering many factors including

    • treatment being discontinued

    • disease severity

    • response to previous treatment, and

    • on expert opinion (some experts will begin administration of the new biologic as soon as it is available; whereas, others may wait 3 to 4 half-lives of the previous therapy before beginning the new biologic).1

  • The British Association of Dermatologists 2017 psoriasis guidelines for biologic therapies include to consider using a washout period of 1 month or the length of a treatment cycle (whichever is longer) when transitioning between biologic therapies.2

  • The Transitioning Therapies programme consensus published in 2014 recommends when switching from one biologic therapy to another to include the use of a washout period if the switch is made due to an AE and do not include a washout period if the switch is made due to a lack of efficacy. Initiation of the second biologic therapy occurs with the usual induction and maintenance dosages.3

Washout Period Requirements in the UNCOVER Clinical Trials

  • There are no specific recommendations on switching from another biologic therapy to ixekizumab for the treatment of psoriasis. 

  • In the pivotal ixekizumab phase 3 UNCOVER clinical trials, patients who were using biologic therapy discontinued biologic treatment prior to the baseline visit and prior to initiating ixekizumab therapy. Required washout periods ranged from at least 3 to 6 times the product's half-life and are listed in Table 1.4

Table 1. Required Washout Periods for Patients Who Switched From Another Biologic Therapy to Ixekizumab in UNCOVER-1, -2, and -3 Clinical Trials4

Biologic

Washout Period

Infliximab

Minimum of 60 days

Adalimumab

Minimum of 60 days

Alefacept

Minimum of 60 days

Golimumab

Minimum of 90 days

Ustekinumab

Minimum of 8 months

Rituximab

Minimum of 12 months

Efalizumab

Minimum of 12 months

Other biologic agent

Minimum of 5 half-lives

Efficacy in Patients Who Switched From a Different Biologic

  • Of all subjects in the 3 ixekizumab UNCOVER clinical trials, 26% had received prior biologic therapy for the treatment of psoriasis.5

  • Table 2 provides PASI75 response rate for patients who switched from a different biologic therapy to ixekizumab in the UNCOVER clinical trials. Examination of previous treatment with a biologic did not identify differences in response to ixekizumab among this subgroup at week 12.5

Table 2. PASI75 Response at Week 12 in Biologic Experienced Patients in UNCOVER-1, -2, and -3 Clinical Trials4,6


n

Response Ratea

n

Response Ratea

n

Response Ratea

Treatment arm

UNCOVER-1

UNCOVER-2

UNCOVER-3

Ixekizumab Q2W

173

87.9

84

92.9

58

89.7

Ixekizumab Q4W

168

78.6

85

74.1

58

79.3

Etanercept

N/A

N/A

76

30.3

60

40.0

Placebo

181

3.3

43

0

33

3.0

Abbreviation: PASI75 = 75% improvement from baseline in Psoriasis Area and Severity Index; Q2W = every 2 weeks; Q4W = every 4 weeks.

a Percentage of patients who switched from another biologic therapy and had a PASI response reduction of at least 75% from baseline.

Additional Information

  • Package inserts for the respective products suggest caution with concomitant use of biologics. Given the small number of biologic switching studies, a washout period may be warranted if a patient switches from 1 biologic therapy to another.1-3 See respective package inserts for infliximab, adalimumab, alefacept, golimumab, ustekinumab, and rituximab.

Enclosed Prescribing Information

TALTZ® (ixekizumab) injection, for subcutaneous administration, Lilly

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. http://dx.doi.org/10.1016/j.jaad.2018.11.057

2. Smith CH, Jabbar-Lopez ZK, Yiu ZZ, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017;177(3):628-636. http://dx.doi.org/10.1111/bjd.15665

3. Mrowietz U, de Jong EMGJ, Kragballe K, et al. A consensus report on appropriate treatment optimization and transitioning in the management of moderate-to-severe plaque psoriasis. J Eur Acad Dermatol Venereol. 2014;28(4):438-453. http://dx.doi.org/10.1111/jdv.12118

4. 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(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711

5. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

6. Gerdes S, Korman N, Wilhelm S, et al. Efficacy of ixekizumab in patients with plaque psoriasis, with and without previous exposure to biologic therapies: results at Weeks 12 and 60 from UNCOVER-1. Poster presented at: 24th Congress of the European Academy of Dermatology and Venereology; October 7-15, 2015; Copenhagen, Denmark.

Glossary

AE = adverse event

PASI75 = 75% improvement from baseline in Psoriasis Area and Severity Index

Date of Last Review: March 13, 2019

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