Taltz® (Ixekizumab)

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Ixekizumab: Corrona Psoriasis Registry

Las características del paciente y la información de seguridad se proporcionan para los participantes tratados con ixekizumab inscritos en el registro de psoriasis de Corrona.

Description of the Corrona Psoriasis Registry

The National Psoriasis Foundation and Corrona, LLC have collaborated to create the largest independent North American psoriasis registry.1 This prospective, multicenter, observational, disease-based registry is designed to study the long-term comparative safety of biologic medications used to treat psoriasis and to analyze the epidemiology and natural history of the disease, current treatment practices, psoriasis comorbidities, and comparative effectiveness in a real world population of psoriasis patients.2

Demographic and clinical data are collected from psoriasis patients who have started on or switched to a systemic psoriasis treatment (biologic or select non-biologic) within the previous 12 months. Questionnaires are completed by the investigator and patient at routine outpatient visits. All treatment decisions are the sole responsibility of the treating clinician(s).2

Outcome measures collected in the Corrona registry include

  • PASI

  • BSA

  • Investigator Global Assessment

  • DLQI

  • Work Productivity and Activity Impairment

  • European Quality of Life - 5 Dimensions - 3 Level

  • Patient Global Assessment

  • Psoriasis Epidemiology Screening Tool

  • Pain VAS

  • Itch VAS, and

  • Fatigue VAS.3

Corrona announced in May of 2016 that it would track drug safety reporting for ixekizumab.4 Nearly 8000 patients have enrolled in the Corrona psoriasis registry. For more information about the registry, please contact info@corrona.org or call (508) 408-5435.3

Patients Exposed to Ixekizumab in the Corrona Psoriasis Registry

Of the 5516 psoriasis patients participating in the Corrona registry as of the July 31, 2018 data cutoff, 1036 patients had received ixekizumab and 558 of those ixekizumab patients were included in the analysis below (patients without a follow-up visit were excluded).5

Patient demographics, disease characteristics, medication history, and comorbidities for patients treated with ixekizumab in the Corrona psoriasis registry are provided in Tabla 1.

Tabla 1. Baseline Characteristics of Ixekizumab-Treated Patients in the Corrona Psoriasis Registry5

 

All IXE Exposure
N=558

PsO Patients
N=308

PsO/PsA Patientsa
N=250

Patient Demographics and Disease Characteristics, mean (SD) unless specified otherwise

Age, years

51.0 (13.2)

49.7 (13.5)

52.7 (12.7)

Female, n (%)

253 (45.3)

135 (43.8)

118 (47.2)

PsO duration, years

17.5 (13.4)

17.0 (12.9)

18.2 (14.1)

PsA duration, yearsa

8.9 (8.9)

N/A

8.9 (8.9)

Medication History, n (%) unless specified otherwise

Phototherapy use count

23 (4.1)

10 (3.2)

13 (5.2)

1 prior non-biologic agent

204 (36.6)

105 (34.1)

99 (39.6)

2 prior non-biologic agents

154 (27.6)

66 (21.4)

88 (35.2)

Biologic naive

88 (15.8)

62 (20.1)

26 (10.4)

1 prior biologic agent

121 (21.7)

72 (23.7)

49 (19.6)

2 prior biologic agents

349 (62.5)

174 (56.5)

175 (70.0)

Duration of IXE exposure, days, mean (SD)b

110.0 (97.0)

103.7 (94.4)

117.3 (100.0)

History of Physician-reported Comorbidities, n (%)

Cancerc

26 (4.7)

11 (3.6)

15 (6.0)

Infection

240 (43.0)

118 (38.3)

122 (48.8)

Serious infectiond

45 (8.1)

18 (5.8)

27 (10.8)

Diabetes mellitus

101 (18.1)

49 (15.9)

52 (20.8)

Metabolic syndrome

9 (1.6)

6 (1.9)

3 (1.2)

GI perforation

1 (0.2)

1 (0.3)

0

Peptic ulcer

8 (1.4)

3 (1.0)

5 (2.0)

Crohn's disease

2 (0.4)

1 (0.3)

1 (0.4)

Ulcerative colitis

1 (0.2)

1 (0.3)

0

Other GI disorders

67 (12.0)

29 (9.4)

38 (15.2)

Abbreviations: GI = gastrointestinal; IXE = ixekizumab; PsA = psoriatic arthritis; PsO = psoriasis.

a Patients with PsO and concomitant PsA.

b Patients characterized as IXE users at study enrollment.

c Any cancer excluding non-melanoma skin cancer (lymphoma, lung, breast, skin [melanoma], others).

d Infections that led to hospitalization or administration of intravenous antibiotics.

Ixekizumab Safety Events

The cumulative IR of safety events for ixekizumab-treated patients in the Corrona registry are listed in Tabla 2. The authors concluded, in this real-world psoriasis population,

  • the IR of safety events did not increase with increasing time of ixekizumab exposure

  • IRs of safety outcomes during the first 24 months of treatment were consistent with those observed in ixekizumab psoriasis clinical trials, and

  • no new safety signals were identified.5

Tabla 2. Cumulative (0-24 Month) Frequency and Incidence Rates of Select Adverse Events in the Corrona Psoriasis Registry5

 

All IXE Exposures
N=558

PsO Patients
N=308

PsO/PsA Patientsa
N=250

 

N

n (%)

IRb

N

n (%)

IRb

N

n (%)

IRb

Serious infections

513

12 (2.3)

2.4

290

4 (1.4)

1.4

223

8 (3.6)

3.8

Opportunistic Infections

427

14 (3.3)

3.5

244

7 (2.9)

3.1

183

7 (3.8)

4.1

Crohn's disease

556

1 (0.2)

0.2

307

1 (0.3)

0.3

249

0

0

Ulcerative colitis

557

0

0

307

0

0

250

0

0

Indeterminate IBD

558

1 (0.2)

0.2

308

1 (0.3)

0.3

250

0

0

Serious hypersensitivity events

554

0

0

307

0

0

247

0

0

Abbreviations: IBD = inflammatory bowel disease; IR = incidence rate; IXE = ixekizumab; PsA = psoriatic arthritis; PsO = psoriasis.

a Patients with PsO and concomitant PsA.

b Incidence rate is expressed as number of unique patients with a particular adverse event per 100 patient-years for cumulative exposure over 0 to 24 months.

References

1. More than 5,000 patients enrolled in Corrona psoriasis registry [press release]. Portland, OR: National Psoriasis Foundation; June 5, 2018. https://www.psoriasis.org/media/press-releases/more-5000-patients-enrolled-corrona%C2%AE-psoriasis-registry. Accessed September 6, 2019.

2. The Corrona psoriasis (PSO) registry. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT02707341. Updated January 4, 2019. Accessed September 6, 2019.

3. PSO registry. Corrona website. https://www.corrona.org/registry/psoriasis. Accessed September 6, 2019.

4. Largest independent U.S. psoriasis registry to track safety of new biologic treatment [press release]. Portland, OR: Corrona, LLC; May 2, 2016. https://www.corrona.org/news/largest-independent-us-psoriasis-registry-track-safety-new-biologic-treatment. Accessed September 6, 2019.

5. Grace E, Zhu B, Malley W, et al. Safety events occurring among patients exposed to ixekizumab in the Corrona psoriasis registry. Poster presented at: 6th Congress of the Skin Inflammation & Psoriasis International Network (SPIN); April 25-27, 2019; Paris, France. https://onlinelibrary.wiley.com/doi/full/10.1111/jdv.15512

Glossary

BSA = body surface area

DLQI = Dermatology Life Quality Index

IR = incidence rate

PASI = Psoriasis Area and Severity Index

VAS = Visual Analog Scale

Fecha de la última revisión: 2019 M09 06

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