STELARA®
(ustekinumab)
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STELARA® (ustekinumab)
Medical Information
Use of STELARA as a Treatment of Lupus
Last Updated: 01/26/2024
SUMMARY
- The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
- A phase 3, multicenter, randomized, placebo-controlled study (LOTUS; N=516) evaluating the efficacy and safety of STELARA in patients with active systemic lupus erythematosus (SLE) was discontinued following a prespecified interim efficacy analysis due to lack of efficacy. Interim safety findings were consistent with the known safety profile of STELARA, and no new safety signals were identified.1
- In a phase 2, randomized, placebo-controlled study (N=102), 62% of STELARA-treated patients achieved a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response vs 33% in the placebo group (P=0.006) at week 24. Treatment effect favoring STELARA was observed at week 12 and sustained through week 48. For patients who were enrolled in the open-label extension, SRI-4 response rates were 79.2% in the STELARA group and 92.3% in the placebo crossover group at week 112.2
- 6 - Case reports that described the use of STELARA for the treatment of cutaneous lupus are also available.7
-11
CLINIcal DATA
Phase 3 Study: LOTUS
van Vollenhoven et al (2022)1 evaluated the efficacy and safety of STELARA in patients with active SLE by the Systemic Lupus International Collaborating Clinics (SLICC) criteria (≥3 months prior to the first study agent administration), an Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥6, and a baseline SLEDAI-2K score of ≥4 for clinical features despite receiving ≥1 standard care treatment in a phase 3, multicenter, randomized, placebo-controlled study (N=516).
Study Design/Methods
- Patients aged 16-75 years with ≥1 British Isles Lupus Assessment Group (BILAG) A and/or ≥2 BILAG B domain scores at screening and a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score of ≥4 or ≥4 joints with pain and signs of inflammation (active joints) at screening and/or week 0 were included in the study.
- Patients were randomized in a 3:2 ratio to receive either STELARA or placebo at baseline with a crossover to STELARA at week 52.
- STELARA was administered as an intravenous (IV) infusion of ∼6 mg/kg at week 0, followed by STELARA 90 mg subcutaneous (SC) injection at week 8 and every 8 weeks (q8w) thereafter.
- The primary endpoint was the proportion of patients who achieved an SRI-4 composite response at week 52.
- Major secondary endpoints included time to first flare through week 52 and proportion of patients with an SRI-4 composite response at week 24.
Results
- Of the 516 patients included in the study, 308 were randomized to receive STELARA and 208 were randomized to receive placebo.
- The study was discontinued early due to lack of efficacy following a prespecified interim analysis.
- At the time of study discontinuation, 153 patients in the STELARA group and 104 patients in the placebo group completed study participation through week 52.
- The modified full analysis set (mFAS) included patients (STELARA, n=173; placebo, n=116) who either completed their week 52 visit or would have had a week 52 visit (based on their last scheduled visit) at the time of study discontinuation.
- At baseline, among all randomized patients, the placebo group had a lower proportion of female patients (STELARA, 94.5%; placebo, 91.8%), and the mean age was higher compared to the STELARA group (STELARA, 42.9 years; placebo, 44.5 years).
- The baseline SLEDAI-2K score (0-105) was as follows:
- All randomized patients: STELARA, 10.4±3.4; placebo, 10.5±3.7
- mFAS: STELARA, 10.5±3.8; placebo, 10.5±3.7
Efficacy
- The primary and major secondary endpoints were not achieved in the study.
In the mFAS population, 43.9% of STELARA patients and 56.0% of placebo patients had an SRI-4 composite response at week 52. - No difference was observed between the treatment groups in response rates for SRI-4 at week 24 or in joint and CLASI response at week 52.
- In the STELARA group, 44.3% of patients had a reduction in glucocorticoid dose at week 40 which was maintained through week 52 compared with 29.3% of patients in the placebo group.
- Through week 52, a BILAG flare was experienced by 28% and 32% of patients in the STELARA and placebo groups, respectively.
- The mean time to first BILAG flare was 204.7 days in the STELARA group and 200.4 days in the placebo group.
Safety
- Interim safety findings were consistent with the known safety profile of STELARA, and no new safety signals were identified.
Through week 52, 69.7% and 74.5% of patients in the STELARA and placebo groups, respectively, reported at least 1 AE. - Serious infections reported in both groups through week 52 included pneumonia (STELARA, n=4; placebo, n=1) and urinary tract infection (STELARA, n=1; placebo, n=2).
- Other serious infections included gastroenteritis, staphylococcal endocarditis, tonsillitis, and vulval cellulitis in the STELARA group and herpes zoster, sepsis, urosepsis, bronchitis, and diverticulitis in the placebo group.
- No opportunistic infections were reported.
- Through week 52, malignancies were reported in 2 patients (diffuse large B-cell lymphoma in the placebo group, n=1; gastric cancer in the STELARA group, n=1), which led to discontinuation of study agent in both patients.
- Infusion reactions were reported in 5 patients in the STELARA group, which led to study discontinuation in 2 patients through week 52.
- Twenty-four (8%) patients tested positive for antibodies to STELARA through week 48; of these, 16 tested positive for neutralizing antibodies.
- Injection-site reactions were reported in 1 of 24 patients (4%) who tested positive for antibodies to STELARA and 4 of 276 patients (1%) who tested negative for antibodies to STELARA through week 52.
- During weeks 52-176, 4 STELARA-treated patients reported a serious infection (Coronavirus Disease 2019 [COVID-19], n=2; gastritis, n=1; pulmonary tuberculosis [TB], n=1).
- Through week 176, 62.3% of all STELARA patients (ie, patients who received at least 1 STELARA dose, including those who crossed over from placebo→STELARA at week 52) reported at least 1 AE.
- Major adverse cardiovascular events were reported in 5 patients (acute myocardial infarction [MI] in the placebo group, n=2; cerebral infarction and embolic stroke in the STELARA group, n=1 each; acute MI in the placebo→STELARA group, n=1).
- Death occurred in 1 patient in the placebo group (splenic rupture) and 5 patients in the STELARA group (4 deaths during weeks 0-52 [hypovolemic shock, cardiac failure due to SLE myocarditis in a patient who was discharged against medical advice, hemorrhagic stroke in a patient with a history of arterial hypertension, and staphylococcal endocarditis] and 1 death during weeks 52-176 [COVID-19 in a patient with a history of asthma]).
Phase 2 Study
van Vollenhoven et al (2018)2,
Study Design/Methods
- Patients were randomized in a 3:2 ratio to receive either STELARA or placebo at baseline.2
- STELARA treatment group received STELARA IV based on weight (260 mg for patients weighing ≥35 kg to ≤55 kg, 390 mg for patients weighing >55 mg to ≤85 kg, and 520 mg for patients weighing >85 kg) at week 0 followed by SC injections of STELARA 90 mg at week 8 and q8w thereafter up to week 40.
- Placebo group received an IV placebo infusion at week 0 followed by SC placebo injections at week 8 and week 16.
- At week 24, patients in the placebo group (n=33) crossed over to receive SC STELARA 90 mg q8w up to week 40.
- The majority of patients in each group were eligible to enter a voluntary open-label study extension and continue receiving SC STELARA q8w through week 104. Patients who participated in the study extension entered at either week 48 or week 56.5
- Twenty-nine patients in the STELARA group and 17 patients in the placebo crossover to STELARA group entered the study extension.
- Patients were stratified based on consent for skin biopsy, disease features (presence of lupus nephritis, baseline concomitant SLE medications, SLEDAI score), site or region and race.2
- The primary endpoint was the proportion of patients who achieved SRI-4 response at week 24.
- Major secondary endpoints at week 24 included the change from baseline in SLEDAI-2K and in Physician’s Global Assessment (PGA), and the proportion of patients with (BILAG)-based Composite Lupus Assessment (BICLA) response.
- Nonresponders were patients with missing data and those who met treatment failures criteria.
- Maintenance of response between week 24 and week 48 and severe BILAG flares (defined as ≥1 new BILAG A score or ≥2 new BILAG B scores) were evaluated using modified intent-to-treat analyses.2,5
- Mucocutaneous disease was evaluated using the CLASI. CLASI response was defined as ≥50% improvement from baseline CLASI activity score in patients with a baseline score of ≥4.2
- Joint disease was evaluated by recording the numbers of joint tender, swollen, and active (defined as demonstrating both pain/tenderness and signs of inflammation joints).
- Joint response was defined as ≥50% improvement from baseline active joint count in patients with ≥4 active joints at baseline.
- Efficacy data were reported as observed data from week 48 through week 112.4,6
- Safety assessments were conducted through week 120.4,6
Results
Efficacy Through Week 48
- Baseline characteristics were similar between the 2 treatment groups which included 91% female patients, mean age of 41, and mean SLEDAI-2K of 10.9.2
- Through week 24, 62% of patients in the STELARA group achieved SRI-4 response vs 33% in the placebo group (P=0.006), with treatment effect favoring STELARA group beginning at week 12. Please see Table: Efficacy Results through Week 24.
- A greater median change from baseline in SLEDAI-2K was also noted in patients treated with STELARA at week 24 compared to patients in the placebo group (-4.4 vs -3.8, respectively; P=0.093).2
- The proportion of patients who achieved SLEDAI-2K response in the STELARA group was maintained through week 48 (65.0% at week 24 and 66.7% at week 48).5
- The mean change from baseline noted in PGA at week 24 was numerically greater in patients treated with STELARA; however, the result was not statistically significant.2
- The proportion of patients achieving a BICLA composite response through week 24 was reported similar between the two treatment groups.2
- The proportion of patients who achieved a BICLA response was 42.4% at week 24 and 48.5% at week 48.5
- The proportion of patients with no worsening in BILAG-2004 score at week 24 (≥1 new BILAG A or ≥2 new BILAG B) was greater in patients treated with STELARA group vs placebo (48% vs 26%, respectively; P=0.0028).2
- The proportion of STELARA treated patients with no worsening from baseline in PGA score, BILAG score, and the proportion of patients with a BICLA response at week 24 were sustained through week 48.5
- Improvements in musculoskeletal and mucocutaneous disease features were also observed with STELARA vs placebo through week 48.
- The proportion of STELARA treated patients with ≥50% improvement from baseline in CLASI activity score was 67.7% at week 28 and 68.6% at week 48.
- The proportion of patients with ≥50% improvement from baseline in the number of active joints was 86.5% at weeks 24 and 48.
- Through weeks 0-24 and 24-48, flare rates for patients with severe BILAG flares were 2.1/10,000 patient-days and 1.1/10,000 patient-days, respectively, in the STELARA group.
- Through weeks 0-24 and 24-48, flare rates for patients with severe BILAG flares were 8.4/10,000 patient-days in the placebo group and 4.6/10,000 patient-days following placebo to STELARA crossover, respectively.
| STELARA (n=60) | Placebo (n=42) | |
|---|---|---|
| Patients with SRI-4 response, n (%); P value | 37.0 (62.0); P=0.006 | 14.0 (33.0) |
| Change from baseline in SLEDAI-2K, median (range) | -4.4 (2.9); P=0.093a,b | -3.8 (5.4) |
| Change from baseline in PGA, median (range); P value | -2.2 (1.9); P=0.394*a,b | -1.9 (2.2) |
| Patients with BICLA response, n (%); P value | 21.0 (35.0); P=0.994*a | 14.0 (33.3) |
| Proportion of BICLA non-responders with no worsening in BILAG, n (%); P value | 29 (48.0); P=0.028* | 11 (26.0) |
| Patients with 50% improvement from baseline CLASI activity scored | 64.1 (43.0 to 80.9); P=0.032*e | 29.9 (12.0-57.0) |
| Abbreviations: BICLA, BILAG-based Combined Lupus Assessment; BILAG, British Isles Lupus Assessment Group; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; PGA, physician’s global assessment; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; SRI-4, SLE Response Index. aPrespecified analyses; all other analyses reported were post-hoc. b c dPatient subpopulation (58% of total population) with CLASI activity score of at least 4 at baseline. eProportion of responders and P values based on a modified intent to treat analysis using a multiple imputation model for missing data from weeks 16 to 24. *Nominal P value; these endpoints were not adjusted for multiple comparisons. Therefore, the p-values displayed are nominal, and statistical significance has not been established. | ||
Efficacy at Week 112 (Open-Label Extension)
- For the patients who entered the open-label extension, SRI-4 response rates were 79.2% in the STELARA group and 92.3% in the placebo crossover group at week 112. Results for endpoints at week 112 are presented in Table: Summary of Efficacy Results at Week 112 for Patients in the Open-Label Extension.4,6
- Improvements of ≥2.5 points in SF-36 PCS scores were observed and maintained from Week 48-72 in the STELARA group and from Week 48 - 104 in the placebo crossover group.6
- Mean improvements of ≥2.5 points in SF-36 MCS scores were observed at Week 24 and Week 72 in the STELARA group, and at Week 24 and from Week 48–104 in the placebo crossover group.
- The rates for severe BILAG flares were 0/10,000 patient-days for the placebo to STELARA crossover group and 1.95/10,000 patient-days in the STELARA group.
| STELARA (n=29) | Placebo→STELARA (n=17)a | |
|---|---|---|
| Patients with SRI-4 response, n/N (%) | 19/24 (79.2) | 12/13 (92.3) |
| Patients with SRI-5 response, n/N (%) | 13/24 (54.2) | 11/13 (84.6) |
| Patients with SRI-6 response, n/N (%) | 13/24 (54.2) | 11/13 (84.6) |
| Patients with SLEDAI-2K response, n/N (%) | 22/24 (91.7) | 12/13 (92.3) |
| Patients with BICLA response, n (%) | 16 (55.2) | 12 (70.6) |
| Patients with PGA response, n/N (%) | 19/24 (79.2) | 13/14 (92.9) |
| Patients with CLASI response, n/N (%) | 11/14 (78.6) | 5/5 (100) |
| Patients with joint response, n/N (%)b | 12/14 (85.7) | 10/11 (90.9) |
| Abbreviations: BICLA, BILAG-based Combined Lupus Assessment; BILAG, British Isles Lupus Assessment Group; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index (response defined as ≥50% improvement from baseline in patients with a baseline CLASI activity score ≥4); PGA, Physician’s Global Assessment (response defined as ≥30% improvement from baseline); SD, standard deviation; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000 (response defined as ≥4-point improvement from baseline); SRI-4/5/6, Systemic Lupus Erythematosus Responder Index (defined as ≥4/5/6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening [<10% increase] from baseline in the PGA). aOf the 33 patients in the PBO group who crossed over at week 24 to receive SC STELARA 90 mg every 8 weeks, 17 patients entered the open-label extension. bJoint response was defined as ≥50% improvement from baseline in the number of active joints in patients with ≥4 active joints at baseline. | ||
Safety
Through Week 56
- Adverse vents through week 56 are summarized in Table: Adverse Events Occurring in >5% of Patients through Week 56.
- Infections were the most common type of AE. Common infections among all STELARAtreated patients were urinary tract infection (18.3%), upper respiratory tract infection (17.2%), and nasopharyngitis (8.6%).5
- Through week 56, 14 (15.1%) STELARA-treated patients had ≥1 serious AE of which 8 patients had serious infection (bronchitis, pneumonia, bacteremia, cellulitis, neutropenic sepsis, Salmonella sepsis, and pyrexia [each in 1 patient], and Stenotrophomonas infection, and urinary tract infection in the same patient). Other serious AEs included glomerulonephritis, hypotension, hypochromic anemia, and fracture (humerus) which occurred after week 24.
- Through week 24 and week 56, more patients in the placebo group discontinued from the study compared to the STELARA treated patients (13 patients [placebo, n=9 (21.4%); STELARA, n=4 (6.7%)] and 6 patients, placebo crossover group n=3 [7.1%]; STELARA, n=3 [5.0%]).
- Through week 56, no deaths, opportunistic infections, cases of TB, or malignancies were reported.
- Through week 56, a total of 92 patients (placebo crossover=32, STELARA, n=60) were treated with STELARA, and of these 10 (31.3%) patients in the placebo crossover group and 6 (10.0%) patients in the STELARA group tested positive for antibodies to STELARA of these, 3 and 2 patients, respectively were positive for neutralizing antibodies.
- Prior to week 24, a 56-year-old patient with baseline risks factors experienced an ischemic stroke. This event was deemed not related to STELARA by investigators.6
| Adverse Event | PBO (Weeks 0-24) (n=42) | PBO→STELARA (n=33)a | Randomized to STELARA (n=60)b | All STELARA (n=93)c |
|---|---|---|---|---|
| Mean follow-up, weeks | 23.8 | 26.4 | 49.5 | 41.3 |
| Patients with ≥1 AE, n (%) | 29 (69.0) | 22 (66.7) | 54 (90) | 76 (81.7) |
| Infections | 20 (47.6) | 15 (45.5) | 40 (66.7) | 55 (59.1) |
| Patients with ≥1 SAE, n (%) | 4 (9.5) | 4 (12.1) | 10 (16.7) | 14 (15.1) |
| Serious infections | 0 | 1 (3.0) | 7 (11.7) | 8 (8.6) |
| Abbreviations: AE, adverse event; PBO, placebo; SAE, serious adverse event. aIncludes only patients who crossed over to receive STELARA. bIncludes all patients who were randomized to receive STELARA at baseline and received ≥1 administration of STELARA. cIncludes all patients in the placebo crossover and STELARA groups who received ≥1 administration of STELARA. | ||||
Through Week 120
- Through week 120, 93 patients received at least 1 administration of STELARA and were included in the analysis. Treatment-emergent AEs through week 120 are summarized in Table: Treatment-Emergent Adverse Events through Week 120.6
- Among STELARA-treated patients, the most common AEs were upper respiratory tract infection (n=23, 22.5%), urinary tract infection (n=21, 20.6%), and nasopharyngitis (n=14, 13.7%).
- Serious AEs were reported in 17 (18.3%) of STELARA-treated patients.
- Two patients had a serious infection during the extension, including viral infection with hospitalization (n=1) and sinusitis (n=1). Both patients recovered.
- Other serious AEs reported including right coronary artery occlusion (n=1), exacerbation of Raynaud’s phenomenon and worsening of SLE and lupus nephritis (n=1)
- The 66-year-old patient with reported coronary artery occlusion had risk factors at baseline. This was determined as not related to STELARA by investigators.
- No injection sites reactions occurred during the study extension.
- A total of 18 (19.6%) STELARA-treated patients tested positive for antibodies to STELARA (placebo crossover, n=11/32; STELARA, n=7/60). Of these, 5 patients had antibody titers of >1:1000 (placebo crossover, n=3; STELARA, n=2).
- Seven STELARA-treated patients tested positive for neutralizing antibodies. No allergic reaction or effect on clinical responses were reported in these patients.
| PBO (Weeks 0-24) (n=42)a | PBO→STELARA (n=33)b | Randomized to STELARA (n=60) | All STELARA (n=93) | |
|---|---|---|---|---|
| Mean follow-up, weeks | 23.8 | 59.8 | 81.1 | 73.6 |
| Patients with ≥1 AE, n (%) | 29 (69.0) | 25 (75.8) | 55 (91.7) | 80 (86.0) |
| Patients with ≥1 infections, n (%) | 20 (47.6) | 18 (54.5) | 44 (73.3) | 62 (66.7) |
| Patients with ≥1 serious infections, n (%) | 0 | 2 (6.1) | 7 (11.7) | 9 (9.7)c |
| Patients with ≥1 opportunistic infections, n | 0 | 0 | 0 | 0 |
| Patients with ≥1 SAE, n (%) | 4 (9.5) | 5 (15.2) | 12 (20.0) | 17 (18.3) |
| Deaths, n | 0 | 0 | 0 | 0 |
| Abbreviations: AE, adverse event; PBO, placebo; SAE, serious adverse event. aPatients who were randomized to the PBO group at week 0 and received PBO through week 24. bPatients in the PBO group who crossed over at week 24 to receive SC STELARA 90 mg every 8 weeks. cNine patients reported a total of 11 serious infections, nine of which occurred prior to week 56. | ||||
Case Reports
| Patient | Case Description | |
|---|---|---|
| Nogueira et al (2021)7 | 41-year-old female with a 4-year history of plaque-type psoriasis who was diagnosed with SLE at 27 years of age. Patient also had a history of antiphospholipidic syndrome, Raynaud’s disease, malar erythema, and pernicious anaemia. Treatment history included hydroxychloroquine, topic corticosteroid and vitamin D analogue, cyclosporine, MTX. | In addition to history of SLE, patient also reported history of antiphospholipidic syndrome (anti-cardiolipin IgG antibodies level of 21 U/mL). Laboratory tests were positive for ANA (titer 1:1,280) and antidsDNA antibodies (titer 1:20). The initial erythrocyte sedimentation rate (ESR) was 41 mm per hour and patient was initiated on hydroxychloroquine 400 mg daily. Patient received many treatments for plaque psoriasis, including topic corticosteroid and vitamin D analogue, cyclosporine, and MTX. Given her history of SLE and plaque psoriasis, 45 mg SC STELARA was initiated at weeks 0 and 4, then every 12 weeks thereafter. PASI 90 response was reported after 20 weeks of treatment. Joint complaints also improved during this period. Hydroxychloroquine dosage was reduced to 200 mg every other day. At week 50, SLE stabilized along with a sustained PASI 90 response and polyarthralgia. Lower ESR (24 mm per hour) was achieved. Laboratory test was also negative for anti-dsDNA antibodies. |
| Romero-Maté et al (2017)8 | 52-year-old female with a 28-year history of histopathologically confirmed discoid lupus erythematosus (DLE). Previous treatments, included topical and intralesional corticosteroids, topical pimecrolimus, antimalarials, acitretin, azathioprine, and dapsone, all were withdrawn due to a lack of response or side effects. | The patient exhibited disfiguring, erythematous and scaly plaques with atrophic scars on the face, neck, and upper back. Several different treatments were administered between 2004 and 2012. Photodynamic therapy was ineffective and was stopped due to side effects. Methylprednisolone boluses, MTX in combination with prednisone, neosidantoine, and cyclosporine were ineffective. Treatment with efalizumab in 2009 was effective but was discontinued when the product was withdrawn from the market that year. Again, MTX in combination with prednisone, acitretin, and thalidomide were prescribed, but resulted in incomplete control of symptoms. A combination of mepacrine and MTX was also unsuccessful. Rituximab was initiated and therapy continued for 6 weeks but then discontinued due to poor results. MTX associated with mycophenolate mofetil was also ineffective. In March of 2012, STELARA was initiated at 45 mg at weeks 0, 4, and every 12 weeks thereafter while the patient was still on MTX, and intralesional corticosteroids were injected into the most active lesions every 4-6 weeks. Improvement was seen and MTX was eventually withdrawn in 2014. She continued STELARA monotherapy every 12 weeks with a few remaining slightly active lesions and no remarkable side effects after 4 years of continuous therapy. |
| Williams et al (2015)9 | 23-year-old female experienced a recrudescence of latent pustular plaque psoriasis (PsO) after anti-TNF treatment for Crohn's disease. | The patient was receiving infliximab for the treatment of her Crohn's disease. Therapy was discontinued after 6 months due to the recrudescence of latent pustular PsO. A month later, she developed erythematous scaly plaques over the cheeks bilaterally. At that time residual serum levels of infliximab were present. ANA was newly positive with low titer (1:160), and dsDNA was negative. The scaly plaques progressed over the next several months to flesh-colored nodules. A punch biopsy revealed mucin in and surrounding the follicules. Treatment with intralesional corticosteroids and STELARA resulted in complete resolution after 1 year of therapy. |
| Dahl et al (2013)10 | 79-year-old female with a 30+ year history of chronic cutaneous lupus erythematosus (CCLE). Previous treatment: topical and systemic glucocorticoids, hydroxychloroquine, azathioprine, thalidomide, MTX, topical calcineurin inhibitors, high-dose intravenous immunoglobulin, and combinations of these. | The patient presented with severe erythema, cutaneous atrophy, hyperpigmentation, scarring and telangiectasias in her face; scarring alopecia and erythema of her scalp; purple erythema, scales and ulcerations on her fingertips, and similar lesions on her toes. She was negative for anti-deoxyribonucleic acid (DNA) antibodies or signs of antiphospholipid syndrome or progression to systemic disease. Biopsies from lesional and nonlesional skin revealed and increase in p40 mRNA expression in the lesional skin compared to the nonlesional skin. Previous treatments did not have significant effects and there were a number of adverse events observed. Treatment with STELARA 45 mg was administered subcutaneously at weeks 0, 4, 16, and 34. Symptom severity was evaluated according to the Cutaneous Disease Area Severity Index (CDASI) scoring system which analyses disease activity based on erythema and scaling, and damage from the disease due to dyspigmentation, scarring and alopecia. A visual analog scale (VAS) was used to evaluate pain and the impact of the disease on the patient. Prior to treatment the disease activity score was 23, the damage score was 19 and the VAS score was 10. After 34 weeks of treatment the disease activity score was 14, the damage score was unchanged and the VAS score was 5. Improvement was observed in the erythema on the patient's face, scalp, and fingers. The ulcers on her fingertips were healed. The erythema on her toes was unchanged. The patient reported feeling better that she had for many years. No adverse events were observed. |
| DeSouza et al (2011)11 | 58-year-old female with a 6-year history of subacute cutaneous lupus erythematosus (SCLE) associated with photosensitivity, arthralgia, and fatigue. Previous treatment included hydroxychloroquine sulfate, dapsone, prednisone, azathioprine, mycophenolate mofetil, topical corticosteroids, and tacrolimus 0.1% ointment. | The patient presented with erythematous and variable hyperkeratotic plaques covering 70% of the body surface area. Laboratory tests were positive for SS-A/Ro and ANA (titer >1:640), but negative for SS-B/La and ds-DNA antibodies. Previous treatment showed limited benefit. STELARA 45 mg was administer according to the approved plaque psoriasis dosing. Marked improvement of the cutaneous eruptions occurred 21 to 30 days after the first injection of STELARA, and the affected area was reduced to 10%, and arthralgias and fatigue resolved. STELARA treatment was continued at week 4, and every 12 weeks thereafter. The patient remained in remission for 7 months while receiving STELARA. There were no adverse events. |
literature search
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References
| 1 | Vollenhoven R van, Kalunian K, Dorner T, et al. Phase 3, multicentre, randomised, placebo-controlled study evaluating the efficacy and safety of ustekinumab in patients with systemic lupus erythematosus. Ann Rheum Dis. 2022;81(11):1556-1563. |
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