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ICOTYDE™ (icotrokinra)
Medical Information
ICOTYDE - Use in Patients with Plaque Psoriasis with a History of Malignancy
Last Updated: 05/04/2026
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- The safety of ICOTYDE in patients with moderate to severe plaque psoriasis (PsO) was evaluated in the ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 phase 3 clinical trials. The following summarizes the available history of malignancy in patients randomized in these studies.1
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CLINICAL PROTOCOLS
- Bissonnette et al (2025)1, Gooderham et al (2025)2
, and Stein Gold et al (2025)3 reported the exclusion criteria for ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2. - Exclusion criteria were assessed during the screening period (weeks -5 to 0) and at week 0 (before first dose of study intervention), and included1-3:
- Current malignancy or a history of malignancy within 5 years before screening (except nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 12 weeks before the first study intervention administration).1-3
- History of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as splenomegaly or significant lymphadenopathy.1-3
CLINICAL DATA
ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2
Medical History
- Available patient medical history was collected during the screening period (weeks -5 to 0) before study initiation.1-3
- History of malignancy in patients randomized in ICONIC studies is summarized in Table: Medical History of Malignancy in ICONIC Clinical Trials.
| n (%) | LEAD (n=684) | TOTAL (n=311) | ADVANCE 1 (n=774) | ADVANCE 2 (n=731) |
|---|---|---|---|---|
| Breast cancer | 1 (0.1) | - | - | 1 (0.1) |
| Cervix carcinoma | 1 (0.1) | 2 (0.6)a | 2 (0.2)b | 1 (0.1) |
| Colorectal cancer | 1 (0.1) | - | - | - |
| GI carcinoma | - | - | 1 (0.1) | - |
| Malignant melanoma | - | 1 (0.3) | 1 (0.1) | 2 (0.3) |
| Ovarian cancer | 2 (0.3)c | 1 (0.3) | - | - |
| Renal cancer | 1 (0.1) | - | - | - |
| Skin cancer | - | - | - | 1 (0.1) |
| Skin SCC | 2 (0.3) | 2 (0.6)d | 3 (0.4)e | 3 (0.4)f |
| Skin BCC | 3 (0.4) | 1 (0.3) | 5 (0.6) | 4 (0.5) |
| Testis cancer | - | - | 1 (0.1) | - |
| Thyroid cancer | 2 (0.3)g | - | - | 1 (0.1) |
| Uterine cancer | - | - | 1 (0.1) | - |
| Abbreviations: BCC, basal cell carcinoma; GI, gastrointestinal; MedDRA, Medical Dictionary for Regulatory Activities; SCC, squamous cell carcinoma. aIncludes cervix carcinoma and cervix carcinoma stage 0.bIncludes cervix carcinoma and cervix carcinoma stage III.cIncludes ovarian cancer and ovarian epithelial cancer.dIncludes SCC and keratoacanthoma.eIncludes Bowen’s disease and SCC.fIncludes Bowen’s disease, SCC of the vulva, and keratoacanthoma.gIncludes thyroid cancer and papillary thyroid cancer.Note: Medical history terms were coded using MedDRA version 27. | ||||
Literature Search
A literature search of MEDLINE®
References
| 1 | Bissonnette R, Soung J, Hebert AA, et al. Protocol to: Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393(18):1784-1795. |
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