STELARA®
(ustekinumab)
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STELARA® (ustekinumab)
Medical Information
Use of STELARA in Patients with Comorbid HIV Infection
Last Updated: 01/29/2025
Summary
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- Please refer to the local labeling for relevant infection-related information for STELARA.
- STELARA should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of STELARA in patients with a chronic infection or a history of recurrent infection.1
- Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, they should be closely monitored and STELARA should not be administered until the infection resolves.1
- In phase 3 clinical trials of STELARA for the treatment of psoriasis (PsO), psoriatic arthritis, Crohn’s disease, and ulcerative colitis, patients with human immunodeficiency virus (HIV) were excluded from the studies.2
- 8 - Additionally, summarized in this response is available data from a retrospective study and case reports of patients receiving STELARA for PsO with a medical history of HIV infection.9
-13
Retrospective Study
Xu et al (2023)9 conducted a retrospective cohort study to evaluate the impact of biological therapies, including STELARA, among patients who are HIV-positive being treated for PsO, comparing them with age-, gender-, and highly active antiretroviral therapy (HAART)-matched patients without PsO.
Study Design/Methods
- A total of 36 patients who are HIV-positive and were receiving biological treatment for chronic PsO between 2010 and 2022 were included in the study.
- Clinical outcomes included the HIV viral load, cluster of differentiation 4 (CD4) cell count, CD4 proportion, number of documented infections, and Psoriasis Area and Severity Index (PASI).
- Data were collected for the first 12 months of biological therapy.
Results
- For demographics and disease characteristics, see Table: Demographics and Disease Characteristics of the Study Population.
| Variable | HIV with Psoriasis (n=36) | HIV with No Psoriasis (n=124) | P-Value |
|---|---|---|---|
| Gender (% male) | 36/36 (100) | 124/124 (100) | 1.00 |
| Age, years, median (IQR) | 53 (11) | 53 (10.5) | 1.00 |
| Years since HIV diagnosis, median (IQR) | 13 (5) | 12 (4) | 0.34 |
| Baseline PASI score, median (IQR) | 24.3 (6.2) | N/A | N/A |
| Patients with reported infections (%) | 10 | 10.5 | 0.96 |
| Patients on HAART (%) | 100 | 100 | 1.00 |
| Abbreviations: HAART, highly active antiretroviral therapy; HIV, human immunodeficiency virus; IQR, interquartile range; N/A, not applicable; PASI, Psoriasis Area and Severity Index. | |||
- The number of patients treated with each biological therapy was as follows: STELARA (n=9), adalimumab (n=7), risankizumab (n=7), secukinumab (n=7), and etanercept (n=6).
- Among patients treated with STELARA, 9/9 (100%) achieved PASI 50 and PASI 75, respectively, while 8/9 (88.9%) and 4/9 (44.4%) achieved PASI 90 and PASI 100, respectively.
During the 12-month period, no significant changes were observed in the CD4 cell count, CD4 proportion, or HIV viral load in patients with PsO who are HIV-positive; see Table: Changes in CD4 Cell Count, CD4 Proportion, and Viral Load Over 0, 3, 6, and 12 Months in Patients with PsO who are HIV-positive and Treated with STELARA.
| Outcomes | P-Value (Month 0 vs Month 12) |
|---|---|
| CD4 cell count (cells/mm3 | 0.915 |
| CD4 proportion (%) | 0.839 |
| Viral load (copies/mL) | 0.99 |
| Note: Statistical significance of change was measured by one-way repeated measures ANOVA with correction for multiple comparisons by the Benjamini-Hochberg procedure. Abbreviations: ANOVA, analysis of variance; CD, cluster of differentiation; HIV, human immunodeficiency virus; PsO, psoriasis. | |
Case Reports
Data on the use of STELARA in the treatment of patients with PsO who are HIV-positive is available through case reports. Please see Table: Summary of Case Reports on the Use of STELARA in Patients with PsO who are HIV-positive.
| Patient | Case Description | |
|---|---|---|
| Munoz et al (2020)10 | A 42-year-old male with a medical history of HBV presented with severe plaque PsO (PASI 23). Patient’s plaque PsO was previously treated with cyclosporine, acitretin, psoralen plus UVA, infliximab, and adalimumab. | Patient’s plaque PsO was eventually treated with STELARA 45 mg every 3 months, which led to a PASI score of 0. Two years after starting STELARA, patient’s serologic tests revealed that he was HIV positive. Patient reported having unprotected sexual intercourse 4 months prior. Patient was referred to infectious disease unit, where he was subsequently treated with raltegravir, ritonavir, darunavir, and abacavir while he continued his plaque PsO treatment with STELARA. Four years following his HIV diagnosis, it was reported that neither his cutaneous nor HIV-associated condition had worsened. |
| Wang et al (2019)11 | A 55-year-old male with a diagnosis of plaque PsO since his 20s developed a severe PsO (75% BSA) after his diagnosis of HIV in 2004. In 2007, his plaque PsO was treated with combinations of topical therapies, narrowband ultraviolet B phototherapy, and acitretin 10-30 mg daily with mild improvement over 96 months. In 2008, he was diagnosed with KS and was treated with imiquimod 5% cream, which provided minimal progression (BSA ~1%). | In 2016, the patient’s HIV and KS were considered stable; however, due to the poor prognosis for his PsO, he was treated with the first dose of STELARA 45 mg, which led to almost complete clearance of PsO. Four weeks following the first dose, there was no change in KS and he received his second dose of STELARA. The patient was on a standard schedule dose every 12 weeks (4 more doses) until his last follow-up appointment. The patient continued to maintain near-clearance of his PsO and his KS lesions, CD4 cell count, and VL remained stable. No AEs or opportunistic infections were reported. |
| Saeki et al (2015)12 | 47-year-old Japanese male diagnosed with an HIV infection and a 20-year history of plaque PsO recalcitrant to etretinate, cyclosporine, and narrow band ultraviolet B. Since 2010, he has been treated with a highly active antiretroviral treatment (abacavir, lamivudine, and raltegravir) with an excellent virological response. | The patient was referred in 2012 with the following parameters: PASI: 15.1, CD4: 602 cells/µL, and VL: 29 copies/mL. The patient was initially treated with adalimumab as PsO significantly impaired his QOL. At months 4 and 6, his PASI was reduced to 1.7 (88% improvement), but increased to 9.7 at month 10 despite an escalation of the dose from 40 to 80 mg. Treatment was switched to STELARA 45 mg. At month 4 of his STELARA treatment, his PASI decreased to 0.8 (92% improvement), QOL improved, and PDI decreased from 25 to 2. No AEs or reduction in CD4 cell count were reported during biological treatment and VL remained undetectable below 20 copies/mL. |
| Paparizos et al (2012)13 | 61-year-old male, MSM, diagnosed with an HIV infection and 35-year known history of plaque PsO recalcitrant to HAART, acitretin, PUVA, methotrexate, cyclosporine, and etanercept. Weight: <100 kg | In October 2009, the patient presented with extensive disease affecting his scalp and trunk, which significantly affected his health-related-QOL. His parameters were PGA: 3, mean PASI: 11.9, CD4: 429 cells/mL, and VL: <50 copies/mL. STELARA 45 mg was administered at weeks 0, 4, and 16. Week 12 evaluation showed a reduction of the PASI: 2.7 (overall improvement of 75.9%). PASI 90 was achieved at week 18. STELARA was well tolerated and no side effects were recorded. Favorable effects on CD4 cell counts were demonstrated without impairment of viral suppression. CD4 cell counts increased to 480 cells/mL after the 2nd injection and 530 cells/mL after 7 months, while VLs remained undetectable below 20 copies/mL. |
| Abbreviations: AE, adverse event; BSA, body surface area; CD, cluster of differentiation; HAART, highly active antiretroviral therapy; HBV, hepatitis B virus; HIV, human immunodeficiency virus; KS, Kaposi sarcoma; MSM, males who have sex with males; PASI, Psoriasis Area and Severity Index; PASI 90, 90% improvement from the initial PASI score; PDI, Psoriasis Disability Index; PGA, Physician Global Assessment; PsO, psoriasis; PUVA, psoralen and ultraviolet A; QOL, quality of life; UVA, ultraviolet A; VL, viral load. | ||
A literature search of MEDLINE®
References
| 1 | Data on File. Ustekinumab Company Core Data Sheet v52. Janssen Research & Development, LLC. EDMS-ERI-22004273; 2024. |
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