(ustekinumab)
Medical inquiries
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)
Medical Information
Occurrence of Alopecia in Adult Patients with Crohn's Disease or Ulcerative Colitis Treated with STELARA
Last Updated: 01/02/2025
SUMMARY
- Summarized in this response are relevant data from an integrated safety analysis, which included the occurrence of alopecia, from the pivotal, phase 3 clinical trial program in adult patients with moderately to severely active Crohn’s disease (CD) or ulcerative colitis (UC) treated with STELARA.1
- Additionally, several prospective and retrospective studies describe the occurrence of alopecia in adults with CD and are summarized below.2
- 8
CLINICAL DATA
Crohn’s Disease and Ulcerative Colitis
The safety and efficacy of STELARA in adults with moderate to severe CD were evaluated in the pivotal, phase 3, randomized, double-blind, placebo-controlled, multicenter clinical program (UNITI).9
Additionally, the safety and efficacy of STELARA in adults with moderate to severe UC were evaluated in the pivotal, phase 3, randomized, double-blind, placebo-controlled, multicenter clinical program (UNIFI).10
For the occurrence of alopecia in adult patients from the CD and UC pivotal clinical trial programs, see Table: Number of Patients with 1 or More Treatment-Emergent Adverse Events on Induction and Maintenance Therapy (Up to 52 Weeks Total) by MedDRA System-Organ Class and Preferred Term; Treated Patients Who Were Randomized in UC and CD Phase 3 Maintenance Studies.1
| Placebo SC Maintenanceb | STELARA 90 mg SC Every 12 Weeksc | STELARA 90 mg SC Every 8 Weeksc | Combined STELARA Group (Every 8 and 12 Weeks)c | |
|---|---|---|---|---|
| Patients treated, n | 308 | 304 | 307 | 611 |
| Average duration of follow-up (weeks) | 47.27 | 49.00 | 48.60 | 48.80 |
| Alopecia, n (%) | 8 (2.6) | 3 (1.0) | 5 (1.6) | 8 (1.3) |
| Abbreviations: CD, Crohn’s disease; IV, intravenous; MedDRA, Medical Dictionary for Regulatory Activities; 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. | ||||
Prospective and Retrospective Studies
Additional data regarding the occurrence of alopecia in adults treated with STELARA are available through several prospective and retrospective studies. Please see Table: Reports of Alopecia in Adult Patients with CD from Prospective and Retrospective Studies.
| Primary Author and Year | Study Design | Patient Population | Dosing Regimen | Occurrence of Alopecia |
|---|---|---|---|---|
| Prospective Studies | ||||
| Gonczi et al (2022)2 | Prospective, multicenter | 142 adults with CD | Induction: UST weight-based IV induction (~6 mg/kg); Maintenance: 90 mg SC at week 8, then q12w | 1 patient reported alopecia but did not discontinue UST |
| Viola et al (2021)3 | Prospective, multicenter | 131 adults with CD | Induction: UST weight-based IV induction (~6 mg/kg); Maintenance: 90 mg SC at week 8 then q8w or q12w | 1 patient reported alopecia but did not discontinue UST |
| Retrospective Studies | ||||
| Johnson et al (2023)4 | Retrospective, multicenter review of the SUCCESSa group | 1113 adults with CD | Induction: UST weight-based IV induction (~6 mg/kg); Maintenance: 90 mg SC at week 8 then q8w | Alopecia was reported in 3 patients |
| Park et al (2022)5 | Retrospective, multicenter | 60 adults with CD of the pouch | UST dosing was not reported | Alopecia was reported in 1 patient |
| Fumery et al (2021)6 | Retrospective, multicenter | 100 adults with CD | UST 90 mg q4w due to LOR or incomplete response to 90 mg SC q8w | Alopecia was reported as 1 of 13 AEs in 12 patients; stabilization of hair loss was reported and did not lead to discontinuation of UST |
| Manlay et al (2021)7 | Retrospective, multicenter | 224 adults with CD | Induction: UST weight-based IV induction (~6 mg/kg); Maintenance: 90 mg SC q8w | 2 patients discontinued UST due to alopecia |
| Hoffman et al (2019)8 | Retrospective, single-center | 57 adults with CD | Induction: UST weight-based IV induction (~6 mg/kg); Maintenance: 90 mg SC at week 8, then q8w or q12w | Alopecia was reported in: 1 patient at week 6 1 patient at week 12 2 patients at week 24 1 patient at week 36 1 patient at week 48 |
| Abbreviations: AE, adverse event; CD, Crohn’s disease; IBD, inflammatory bowel disease; IV, intravenous; LOR, loss of response; q12w, every 12 weeks; q8w, every 8 weeks; SC, subcutaneous; UST, ustekinumab. aSUCCESS: IBD Health Outcomes Consortium substudy group. | ||||
Literature Search
A literature search of MEDLINE®
References
| 1 | Data on File. Integrated Summary of Safety. Janssen Research and Development, LLC. EDMS-ERI-166475058; 2018. |
| 2 | |
| 3 | |
| 4 | |
| 5 | |
| 6 | |
| 7 | |
| 8 | |
| 9 | |
| 10 |