Taltz® (Ixekizumab)

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Ixekizumab: How to switch to 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.

References

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.

Fecha de la última revisión: 2019 M03 13


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