For Healthcare Professionals - STELARA®

Submitted by site_admin on Mon, 11/09/2009 - 07:44

STELARA^® is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

For Important Safety Information Regarding Potential Risks of Serious Infections and Malignancy, and Reversible Posterior Leukoencephalopathy Syndrome (RPLS), please click here.

Significant Clearance at week 12

In PHOENIX 2:
-7 out of 10 patients on STELARA^® (45 mg: 67% [273/409] and 90 mg: 76%
[311/411]) achieved PASI 75 by Week 12 vs 4% (15/410) of placebo patients
(P<0.0001 vs placebo for each dose).^1,2
-7 out of 10 patients on STELARA^® (45 mg: 68% [277/409] and 90 mg: 73% [300/411]) achieved treatment success (defined as PGA score of Cleared or Minimal) by Week 12 vs 4% (18/410) of placebo patients (P<0.0001 vs placebo for each dose).^1,2
In PHOENIX 1:
-7 out of 10 patients on STELARA^® (45 mg: 67% [171/255] and 90 mg: 66% [170/256]) achieved PASI 75 by Week 12 vs 3% (8/255) of placebo patients (P<0.0001 vs placebo for each dose).^1,3
-6 out of 10 patients on STELARA^® (45 mg: 59% [151/255] and 90 mg: 61% [156/256]) achieved treatment success (defined as PGA score of Cleared or Minimal) by Week 12 vs 4% (10/255) of placebo patients (P<0.0001 vs placebo for each dose).^1,3

Clearance at week 100

8 out of 10 Weeks 28 and 40 responders receiving STELARA^® 45 mg or 90 mg
every 12 weeks (84% [134/159]) maintained PASI 75 response at Week 76.⁴
In an open-label extension, PASI 75 response rates remained generally consistent in patients receiving STELARA^® 45 mg or 90 mg every 12 weeks (78% [123/158] at Week 100; 83% [123/149] at Week 148; 80% [112/140] at Week 244.⁵
- After Week 76, treatment was unblinded and concomitant topicals were allowed.³

Quarterly Maintenance Dosing for your patients

Dosed once every 12 weeks, after 2 starter doses at Weeks 0 and 4.¹

STELARA^®, available as 45 mg and 90 mg, is a subcutaneous injection that should only be administered by a healthcare provider to patients who have regular follow-up with the physician.¹

Unique Molecule

STELARA^® selectively targets interleukin (IL)-12 and IL-23.¹

*PHOENIX 2 evaluated 1,230 patients who began the study receiving STELARA^® 45 mg or 90 mg or placebo. Patients randomized to STELARA^® received STELARA^® at Weeks 0 and 4, followed by the same dose every 12 weeks through Week 28. Patients in the placebo group (n=410) crossed over to receive either STELARA^® 45 mg or 90 mg at Weeks 12 and 16, followed by the same dose every 12 weeks. Eligible patients were adults with a diagnosis of plaque psoriasis for ≥6 months involving ≥10% body surface area (BSA), PASI score ≥12, and who were candidates for phototherapy or systemic therapy.^1,2

^†PHOENIX 1 evaluated 766 patients who received STELARA^® or placebo. The study design was identical to PHOENIX 2 through Week 28. Inclusion criteria were consistent with PHOENIX 2. At Week 40, 322 of the 511 patients initially randomized to STELARA^® who were PASI 75 responders at both Weeks 28 and 40 were rerandomized either to continue every-12-week dosing with STELARA^® (n=162) or to placebo (n=160). Patients rerandomized to STELARA^® at Week 40 were considered treatment failures if they discontinued STELARA^® due to unsatisfactory therapeutic effect, experienced an adverse event of worsening of psoriasis, or started non-topical protocol-prohibited medications.^1,3,4

After Week 76, treatment was unblinded, and treatment failure rules were relaxed to allow for use of concomitant topical medications, except for high-potency corticosteroids. The analyses at Weeks 76, 100, 148, and 244 include all patients randomized at Week 40 to continue every-12-week dosing with STELARA^®, except those who discontinued STELARA^® due to an adverse event or were lost to follow-up.^1,3,4

Important Safety Information

Infections
STELARA^® (ustekinumab) may increase the risk of infections and reactivation of latent infections. Serious bacterial, fungal, and viral infections were reported. Infections requiring hospitalization included cellulitis, diverticulitis, osteomyelitis, gastroenteritis, pneumonia, and urinary tract infections. STELARA^® should not be given to patients with a clinically important active infection and should not be administered until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. Exercise caution when considering use of STELARA^® in patients with a chronic infection or a history of recurrent infection.

Theoretical Risk for Vulnerability to Particular Infections
Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacterium, Salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA^® will be susceptible to these types of infections. Consider appropriate diagnostic testing as dictated by clinical circumstances.

Pre-Treatment Evaluation of Tuberculosis (TB)
Evaluate patients for TB prior to initiating treatment with STELARA^®. STELARA^® should not be given to patients with active TB. Initiate treatment of latent TB before administering STELARA^®. Patients should be monitored closely for signs and symptoms of active TB during and after treatment with STELARA^®.

Malignancies
STELARA^® is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among patients who received STELARA^® in clinical studies. The safety of STELARA^® has not been evaluated in patients who have a history of malignancy or who have a known malignancy.

There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA^® who had risk factors for developing non-melanoma skin cancer (NMSC). All patients receiving STELARA^®, especially those >60 years or those with a history of PUVA or prolonged immunosuppressant treatment, should be monitored for the appearance of NMSC.

Hypersensitivity Reactions
STELARA^® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or excipients. Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, discontinue STELARA^® and institute appropriate therapy.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
One case of RPLS has been reported in a STELARA^®-treated patient. If RPLS is suspected, discontinue STELARA^® and administer appropriate treatment.
RPLS is a neurological disorder, which is not caused by an infection or demyelination. RPLS can present with headache, seizures, confusion, and visual disturbances. RPLS has been associated with fatal outcomes.

Immunizations
Prior to initiating therapy with STELARA^®, patients should receive all immunizations recommended by current guidelines. Patients being treated with STELARA^® should not receive live vaccines. BCG vaccines should not be given during treatment or within one year of initiating or discontinuing STELARA^®. Exercise caution when administering live vaccines to household contacts of STELARA^® patients, as shedding and subsequent transmission to STELARA^® patients may occur. Non-live vaccinations received during a course of STELARA^® may not elicit an immune response sufficient to prevent disease.

Concomitant Therapies
The safety of STELARA^® in combination with other immunosuppressive agents or phototherapy has not been evaluated. Ultraviolet-induced skin cancers developed earlier and more frequently in mice genetically manipulated to be deficient in both IL-12 and IL-23 or IL-12 alone. The relevance of these findings in mouse models for malignancy risk in humans is unknown.

Allergen Immunotherapy
STELARA^® may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.

Most Common Adverse Reactions
The most common adverse reactions (≥3% and higher than that with placebo) in clinical trials for STELARA^® 45 mg, STELARA^® 90 mg, or placebo were: nasopharyngitis (8%, 7%, 8%), upper respiratory tract infection (5%, 4%, 5%), headache (5%, 5%, 3%), and fatigue (3%, 3%, 2%), respectively.

Please see accompanying full Prescribing Information and Medication Guide for STELARA^®. Provide the Medication Guide to your patients and encourage discussion.

K25ST13010

References: 1. STELARA^® Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 2. Papp KA, Langley RG, Lebwohl M, et al; for the PHOENIX 2 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371(9625):1675-1684. 3. Leonardi CL, Kimball AB, Papp KA, et al; for the PHOENIX 1 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371(9625):1665-1674. 4. Data on file. Janssen Biotech, Inc. 5. Kimball AB, Papp KA, Wasfi Y, et al; on behalf of the PHOENIX 1 investigators. Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study [published online ahead of print December 20, 2012]. J Eur Acad Dermatol Venereol. doi: 10.1111/jadv.12046. 6. HUMIRA^® Prescribing Information. North Chicago, IL: Abbott Laboratories. 7. ENBREL^® Prescribing Information. Thousand Oaks, CA: Immunex Corporation. 8. Reich K, Papp KA, Griffiths CEM, et al; PHOENIX 1, PHOENIX 2, and ACCEPT investigators. An update on the long-term safety experience of ustekinumab: results from the psoriasis clinical development program with up to four years of follow-up. J Drugs Dermatol. 2012;11(3):300-312. 9. Papp KA, Griffiths CE, Gordon K, et al; on behalf of the PHOENIX 1, PHOENIX 2, ACCEPT Investigators. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from five years of follow-up [published online ahead of print January 10, 2013]. Br J Dermatol. doi: 10.1111/bjd.12214.