Taltz® ▼ (ixekizumab): Corrona Psoriasis Registry

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.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 Table 1.

Table 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 Table 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

Please refer to the Taltz summary of product characteristics for full information on adverse drug reactions.⁶

Table 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.

Therapeutic Indication

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.⁶

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: 6^th 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

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

Glossary

BSA = body surface area

DLQI = Dermatology Life Quality Index

IR = incidence rate

PASI = Psoriasis Area and Severity Index

VAS = Visual Analog Scale

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.