Om du vill rapportera en biverkning gällande en av Lillys produkter, kontakta oss via e-post på DK_PHv@lilly.com eller på telefon +45 4526 6040. Har du ytterligare medicinska frågor gällande en av Lillys produkter, kontakta oss via länken ovan.
Taltz ® (ixekizumab) injektion
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
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 |
PsO
Patients |
PsO/PsA
Patientsa |
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 |
PsO
Patients |
PsO/PsA
Patientsa |
||||||
|
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
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
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
Datum fӧr senaste ӧversyn 2019 M09 06