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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

STELARA® (ustekinumab)

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STELARA - Occurrence of Skin-Related Adverse Events in Crohn’s Disease and Ulcerative Colitis

Last Updated: 10/21/2024

SUMMARY

The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
Summarized in this response are relevant data from an integrated safety analysis of skin-related adverse events from the pivotal phase 3 clinical trials in adult patients with moderate to severe Crohn’s disease (CD) or ulcerative colitis (UC) receiving STELARA.¹

CLINICAL DATA

CROHN’S DISEASE AND ULCERATIVE COLITIS

Feagan et al (2016)² reported the efficacy and safety of STELARA through 3 randomized, double-blind, placebo-controlled, clinical trials in adult patients with moderate to severe CD. There were two 8-week intravenous (IV) induction studies (UNITI-1 and UNITI-2) followed by a 44-week subcutaneous (SC) randomized withdrawal maintenance study (IM-UNITI), representing 52 weeks of therapy.

Sands et al (2019)³ reported the efficacy and safety of STELARA in adult patients with moderate to severe UC through a phase 3 randomized, double-blind, placebo-controlled, multicenter clinical program (UNIFI).The program consisted of an 8-week IV induction study and a 44-week SC maintenance study, representing 52 weeks of therapy.

Results

For data on skin and SC tissue disorders, see Table: Number of Patients with ≥1 Treatment-Emergent Adverse Events on Induction and Maintenance Therapy (Up to 52 Weeks Total^a) by MedDRA System-Organ Class and Preferred Term; Treated Patients Who Were Randomized in UC and CD Phase 3 Maintenance Studies.

Number of Patients with ≥1 Treatment-Emergent Adverse Events on Induction and Maintenance Therapy (Up to 52 Weeks Total^a) by MedDRA System-Organ Class and Preferred Term; Treated Patients Who Were Randomized in UC and CD Phase 3 Maintenance Studies¹

	Placebo SC Maintenance^b	STELARA 90 mg SC Q12W^c	STELARA 90 mg SC Q8W^c	Combined STELARA Group (Q12W and Q8W)^c
Patients treated, n	308	304	307	611
Average duration of follow-up (weeks)	47.27	49.00	48.60	48.80
Skin and SC tissue disorders, n (%)	67 (21.8)	52 (17.1)	77 (25.1)	129 (21.1)
Rash	15 (4.9)	11 (3.6)	16 (5.2)	27 (4.4)
Pruritus	11 (3.6)	8 (2.6)	10 (3.3)	18 (2.9)
Acne	2 (0.6)	5 (1.6)	8 (2.6)	13 (2.1)
Eczema	7 (2.3)	6 (2.0)	5 (1.6)	11 (1.8)
Alopecia	8 (2.6)	3 (1.0)	5 (1.6)	8 (1.3)
Night sweats	8 (2.6)	3 (1.0)	4 (1.3)	7 (1.1)
Rash pruritic	2 (0.6)	2 (0.7)	5 (1.6)	7 (1.1)
Dermatitis	0	2 (0.7)	3 (1.0)	5 (0.8)
Dry skin	3 (1.0)	3 (1.0)	2 (0.7)	5 (0.8)
Erythema	0	1 (0.3)	4 (1.3)	5 (0.8)
Urticaria	3 (1.0)	4 (1.3)	1 (0.3)	5 (0.8)
Dermatitis contact	1 (0.3)	1 (0.3)	3 (1.0)	4 (0.7)
Hyperhidrosis	0	1 (0.3)	3 (1.0)	4 (0.7)
Dermatitis acneiform	1 (0.3)	2 (0.7)	1 (0.3)	3 (0.5)
Hidradenitis	0	2 (0.7)	1 (0.3)	3 (0.5)
Psoriasis	3 (1.0)	1 (0.3)	2 (0.7)	3 (0.5)
Rash generalized	0	1 (0.3)	2 (0.7)	3 (0.5)
Actinic keratosis	0	1 (0.3)	1 (0.3)	2 (0.3)
Dermal cyst	0	0	2 (0.7)	2 (0.3)
Dermatitis psoriasiform	0	0	2 (0.7)	2 (0.3)
Dyshidrotic eczema	0	1 (0.3)	1 (0.3)	2 (0.3)
Hyperkeratosis	0	1 (0.3)	1 (0.3)	2 (0.3)
Lichen planus	1 (0.3)	2 (0.7)	0	2 (0.3)
Perioral dermatitis	1 (0.3)	1 (0.3)	1 (0.3)	2 (0.3)
Pruritus generalized	1 (0.3)	1 (0.3)	1 (0.3)	2 (0.3)
Rash erythematous	2 (0.6)	2 (0.7)	0	2 (0.3)
Rash papular	0	2 (0.7)	0	2 (0.3)
Rash vesicular	0	0	2 (0.7)	2 (0.3)
Skin disorder	1 (0.3)	1 (0.3)	1 (0.3)	2 (0.3)
Skin irritation	0	0	2 (0.7)	2 (0.3)
Skin lesion	3 (1.0)	0	2 (0.7)	2 (0.3)
Skin ulcer	1 (0.3)	2 (0.7)	0	2 (0.3)
Acne conglobata	0	0	1 (0.3)	1 (0.2)
Blister	0	1 (0.3)	0	1 (0.2)
Cold sweat	0	0	1 (0.3)	1 (0.2)
Decubitus ulcer	0	1 (0.3)	0	1 (0.2)
Dermatitis allergic	0	1 (0.3)	0	1 (0.2)
Ecchymosis	0	1 (0.3)	0	1 (0.2)
Eczema asteatotic	0	0	1 (0.3)	1 (0.2)
Eczema nummular	0	0	1 (0.3)	1 (0.2)
Erythema nodosum	1 (0.3)	1 (0.3)	0	1 (0.2)
Ingrowing nail	0	0	1 (0.3)	1 (0.2)
Lichenoid keratosis	0	0	1 (0.3)	1 (0.2)
Miliaria	0	0	1 (0.3)	1 (0.2)
Rash maculo-papular	0	0	1 (0.3)	1 (0.2)
Rosacea	0	1 (0.3)	0	1 (0.2)
Seborrhoeic dermatitis	0	0	1 (0.3)	1 (0.2)
Skin discolouration	1 (0.3)	0	1 (0.3)	1 (0.2)
Skin hypopigmentation	0	0	1 (0.3)	1 (0.2)
Vitiligo	1 (0.3)	1 (0.3)	0	1 (0.2)
Acne cystic	1 (0.3)	0	0	0
Dermatitis atopic	1 (0.3)	0	0	0
Dermatosis	1 (0.3)	0	0	0
Livedo reticularis	1 (0.3)	0	0	0
Nail disorder	1 (0.3)	0	0	0
Onychoclasis	1 (0.3)	0	0	0
Papule	2 (0.6)	0	0	0
Photosensitivity reaction	2 (0.6)	0	0	0
Abbreviations: CD, Crohn’s disease; IV, intravenous; MedDRA, Medical Dictionary for Regulatory Activities; Q12W, every 12 weeks; Q8W, every 8 weeks; SC, subcutaneous; UC, ulcerative colitis. ^aUp to 60 weeks for patients who entered maintenance at week 16 of the induction study in UC. ^bPatients who were in clinical response to STELARA IV induction dosing and were randomized to placebo SC on entry into this maintenance study. ^cIncludes data up to the time of meeting loss of response criteria for patients who had a dose adjustment in CD.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 21 October 2024.

Summarized in this response are relevant safety data from pivotal phase 3 clinical trials in adult patients with moderate to severe CD or UC.

References

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1	Data on File. Integrated Summary of Safety. Janssen Research and Development, LLC. EDMS-ERI-166475058; 2018.
2	Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. New Engl J Med. 2016;375(20):1946-1960.
3	Sands BE, Sandborn WJ, Panaccione R, et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2019;381(13):1201-1214.