ustekinumab

5 WARNINGS AND PRECAUTIONS Infections : Serious infections have occurred. Avoid starting Ustekinumab during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue Ustekinumab until the infection resolves. ( 5.1 ) Theoretical Risk for Particular Infections : Serious infections from mycobacteria, salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. ( 5.2 ) Tuberculosis (TB) : Evaluate patients for TB prior to initiating treatment with Ustekinumab. Initiate treatment of latent TB before administering Ustekinumab. ( 5.3 ) Malignancies : Ustekinumab may increase risk of malignancy. The safety of Ustekinumab in patients with a history of or a known malignancy has not been evaluated. ( 5.4 ) Serious Hypersensitivity Reactions : If a severe or other clinically significant hypersensitivity reaction occurs, discontinue Ustekinumab immediately and initiate appropriate medical treatment. ( 5.5 ) Posterior Reversible Encephalopathy Syndrome (PRES) : If PRES is suspected, treat promptly, and discontinue Ustekinumab. ( 5.6 ) Immunizations : Avoid use of live vaccines in patients during treatment with Ustekinumab. ( 5.7 ) Noninfectious Pneumonia : Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of Ustekinumab. If diagnosis is confirmed, discontinue Ustekinumab and institute appropriate treatment. ( 5.8 ) 5.1 Infections Ustekinumab may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving Ustekinumab [see Adverse Reactions (6.1 , 6.2) ] . Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque Psoriasis : diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. Psoriatic arthritis : cholecystitis. Crohn's disease in adults : anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis. Crohn's disease in pediatrics : Aeromonas gastroenteritis. Ulcerative colitis in adults : gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis. Ulcerative colitis in pediatrics : salmonellosis and cytomegalovirus. Avoid initiating treatment with Ustekinumab in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of Ustekinumab in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with Ustekinumab and discontinue Ustekinumab for serious or clinically significant infections until the infection resolves or is adequately treated. 5.2 Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), 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 Ustekinumab may be susceptible to these types of infections. Consider appropriate diagnostic testing, (e.g., tissue culture, stool culture, as dictated by clinical circumstances). 5.3 Pre-treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis infection prior to initiating treatment with Ustekinumab. Avoid administering Ustekinumab to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering Ustekinumab. Consider anti-tuberculosis therapy prior to initiation of Ustekinumab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving Ustekinumab for signs and symptoms of active tuberculosis during and after treatment. 5.4 Malignancies Ustekinumab is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among subjects who received Ustekinumab in clinical trials [see Adverse Reactions (6.1) ] . In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy [see Nonclinical Toxicology (13.1) ] . The safety of Ustekinumab has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving Ustekinumab who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving Ustekinumab for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment [see Adverse Reactions (6.1) ] . 5.5 Serious Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Ustekinumab in clinical trials and postmarketing. Some serious hypersensitivity reactions have occurred during the first intravenous dose of Ustekinumab [see Adverse Reactions (6.1 , 6.2) ]. If a severe or clinically significant hypersensitivity reaction occurs, discontinue Ustekinumab immediately and initiate appropriate medical treatment [see Contraindications (4) ]. 5.6 Posterior Reversible Encephalopathy Syndrome (PRES) Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab. Monitor all patients treated with Ustekinumab for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue Ustekinumab. 5.7 Immunizations Prior to initiating therapy with Ustekinumab, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with Ustekinumab should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with Ustekinumab or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving Ustekinumab because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of Ustekinumab may not elicit an immune response sufficient to prevent disease. 5.8 Noninfectious Pneumonia Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of Ustekinumab. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue Ustekinumab and institute appropriate treatment [see Adverse Reactions (6.2) ] .

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the label: Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.4) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.6) ] Noninfectious Pneumonia [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Psoriasis and Psoriatic Arthritis (≥3%) : nasopharyngitis, upper respiratory tract infection, headache, and fatigue. ( 6.1 ) Crohn's Disease induction (≥3%): vomiting. ( 6.1 ) maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. ( 6.1 ) Ulcerative Colitis induction (≥3%): nasopharyngitis. ( 6.1 ) maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Subjects with Plaque Psoriasis The safety data reflect exposure to Ustekinumab in 3117 adult subjects with plaque psoriasis, including 2414 exposed for at least 6 months, 1855 exposed for at least one year, 1653 exposed for at least two years, 1569 exposed for at least three years, 1482 exposed for at least four years and 838 exposed for at least five years. Table 9 summarizes the adverse reactions that occurred at a rate of at least 1% with higher rates in the Ustekinumab groups during the placebo-controlled period of Ps STUDY 1 and Ps STUDY 2 [see Clinical Studies (14.1) ] . Table 9: Adverse Reactions, Reported by ≥1% of Subjects with Plaque Psoriasis and at Higher Rates in the Ustekinumab Groups through Week 12 in Ps STUDY 1 and Ps STUDY 2 Ustekinumab Placebo 45 mg 90 mg Subjects treated 665 664 666 Nasopharyngitis 51 (8%) 56 (8%) 49 (7%) Upper respiratory tract infection 30 (5%) 36 (5%) 28 (4%) Headache 23 (3%) 33 (5%) 32 (5%) Fatigue 14 (2%) 18 (3%) 17 (3%) Back pain 8 (1%) 9 (1%) 14 (2%) Dizziness 8 (1%) 8 (1%) 14 (2%) Pharyngolaryngeal pain 7 (1%) 9 (1%) 12 (2%) Pruritus 9 (1%) 10 (2%) 9 (1%) Injection site erythema 3 (<1%) 6 (1%) 13 (2%) Myalgia 4 (1%) 7 (1%) 8 (1%) Depression 3 (<1%) 8 (1%) 4 (1%) Adverse reactions that occurred at rates less than 1% in the controlled period of Ps STUDIES 1 and 2 through week 12 included: cellulitis, herpes zoster, diverticulitis, and certain injection site reactions (pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation). One case of PRES occurred during clinical trials in adult subjects with plaque psoriasis [see Warnings and Precautions (5.6) ] . Infections In the placebo-controlled period of clinical trials of subjects with plaque psoriasis (average follow-up of 12.6 weeks for subjects receiving placebo and 13.4 weeks for Ustekinumab-treated subjects), 27% of Ustekinumab-treated subjects reported infections (1.39 per patient-years of follow-up) compared with 24% of subjects receiving placebo (1.21 per patient-years of follow-up). Serious infections occurred in 0.3% of Ustekinumab-treated subjects (0.01 per patient-years of follow-up) and in 0.4% of subjects receiving placebo (0.02 per patient-years of follow-up) [see Warnings and Precautions (5.1) ] . In the controlled and non-controlled portions of clinical trials in subjects with plaque psoriasis (median follow-up of 3.2 years), representing 8998 patient-years of exposure, 72.3% of Ustekinumab-treated subjects reported infections (0.87 per patient-years of follow-up). Serious infections were reported in 2.8% of subjects (0.01 per patient-years of follow-up). Malignancies In the controlled and non-controlled portions of clinical trials in subjects with plaque psoriasis (median follow-up of 3.2 years, representing 8998 patient-years of exposure), 1.7% of Ustekinumab-treated subjects reported malignancies excluding non-melanoma skin cancers (0.60 per hundred patient-years of follow-up). Non-melanoma skin cancer was reported in 1.5% of Ustekinumab-treated subjects (0.52 per hundred patient-years of follow-up) [see Warnings and Precautions (5.4) ] . The most frequently observed malignancies other than non-melanoma skin cancer during the clinical trials were: prostate, melanoma, colorectal and breast. Malignancies other than non-melanoma skin cancer in Ustekinumab-treated subjects during the controlled and uncontrolled portions of trials were similar in type and number to what would be expected in the general U.S. population according to the 1969–2004 SEER database (adjusted for age, gender and race). Pediatric Subjects with Plaque Psoriasis The safety of Ustekinumab was assessed in two trials of pediatric subjects with moderate to severe plaque psoriasis. Ps STUDY 3 evaluated safety for up to 60 weeks in 110 pediatric subjects 12 to 17 years old. Ps STUDY 4 evaluated safety for up to 56 weeks in 44 pediatric subjects 6 to 11 years old. The safety profile in pediatric subjects was similar to the safety profile from trials in adults with plaque psoriasis. Psoriatic Arthritis The safety of Ustekinumab was assessed in 927 subjects in two randomized, double-blind, placebo-controlled trials in adults with active psoriatic arthritis (PsA). The overall safety profile of Ustekinumab in subjects with PsA was consistent with the safety profile seen in clinical trials in adult subjects with plaque psoriasis. A higher incidence of arthralgia, nausea, and dental infections was observed in Ustekinumab-treated subjects when compared with placebo-treated subjects (3% vs. 1% for arthralgia and 3% vs. 1% for nausea; 1% vs. 0.6% for dental infections) in the placebo-controlled portions of the PsA clinical trials. Adult Subjects with Crohn's Disease The safety of Ustekinumab was assessed in 1407 subjects with moderately to severely active Crohn's disease (Crohn's Disease Activity Index [CDAI] greater than or equal to 220 and less than or equal to 450) in three randomized, double-blind, placebo-controlled, parallel-group, multicenter trials. These 1407 subjects included 40 subjects who received a prior investigational intravenous ustekinumab formulation but were not included in the efficacy analyses. In trials CD-1 and CD-2 there were 470 subjects who received Ustekinumab 6 mg/kg as a weight-based single intravenous induction dose and 466 who received placebo [see Dosage and Administration (2.3) ] . Subjects who were responders in either trial CD-1 or CD-2 were randomized to receive a subcutaneous maintenance regimen of either 90 mg Ustekinumab every 8 weeks, or placebo for 44 weeks in trial CD-3. Subjects in these 3 trials may have received other concomitant therapies including aminosalicylates, immunomodulatory agents [azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate (MTX)], oral corticosteroids (prednisone or budesonide), and/or antibiotics for their Crohn's disease [see Clinical Studies (14.4) ] . The overall safety profile of Ustekinumab was consistent with the safety profile seen in the clinical trials in adult subjects with plaque psoriasis and psoriatic arthritis. Common adverse reactions in trials CD-1 and CD-2 and in trial CD-3 are listed in Tables 10 and 11, respectively. Table 10: Common Adverse Reactions Through Week 8 in Trials CD-1 and CD-2 occurring in ≥3% of Ustekinumab-Treated Subjects and Higher Than Subjects Receiving Placebo Placebo N=466 Ustekinumab 6 mg/kg Single Intravenous Induction Dose N=470 Vomiting 3% 4% Other less common adverse reactions reported in subjects in trials CD-1 and CD-2 included asthenia (1% vs 0.4%), acne (1% vs 0.4%), and pruritus (2% vs 0.4%). Table 11: Common Adverse Reactions Through Week 44 in Trial CD-3 occurring in ≥3% of Ustekinumab-Treated Subjects and Higher Than Subjects Receiving Placebo Placebo N=133 Ustekinumab 90 mg Subcutaneous Maintenance Dose Every 8 Weeks N=131 Nasopharyngitis 8% 11% Injection site erythema 0 5% Vulvovaginal candidiasis/mycotic infection 1% 5% Bronchitis 3% 5% Pruritus 2% 4% Urinary tract infection 2% 4% Sinusitis 2% 3% Infections In subjects with Crohn's disease, serious or other clinically significant infections included anal abscess, gastroenteritis, and pneumonia. In addition, listeria meningitis and ophthalmic herpes zoster were reported in one subject each [see Warnings and Precautions (5.1) ] . Malignancies With up to one year of treatment in the Crohn's disease clinical trials, 0.2% of Ustekinumab-treated subjects (0.36 events per hundred patient-years) and 0.2% of placebo-treated subjects (0.58 events per hundred patient-years) developed non-melanoma skin cancer. Malignancies other than non-melanoma skin cancers occurred in 0.2% of Ustekinumab-treated subjects (0.27 events per hundred patient-years) and in none of the placebo-treated subjects [see Warnings and Precautions (5.4) ] . Hypersensitivity Reactions Including Anaphylaxis In CD trials, two subjects reported hypersensitivity reactions following Ustekinumab administration. One subject experienced signs and symptoms consistent with anaphylaxis (tightness of the throat, shortness of breath, and flushing) after a single subcutaneous administration (0.1% of subjects receiving subcutaneous Ustekinumab). In addition, one subject experienced signs and symptoms consistent with or related to a hypersensitivity reaction (chest discomfort, flushing, urticaria, and increased body temperature) after the initial intravenous Ustekinumab dose (0.08% of subjects receiving intravenous Ustekinumab). These subjects were treated with oral antihistamines or corticosteroids and in both cases symptoms resolved within an hour [see Warnings and Precautions (5.5) ] . Pediatric Subjects with Crohn's Disease The safety of Ustekinumab has been studied in 101 pediatric subjects (2 to 17 years of age) with moderately to severely active Crohn's disease and 48 subjects received the recommended maintenance dosage [see Clinical Studies (14.5) ] . In general, adverse reactions reported in the clinical trial of pediatric subjects with Crohn's disease were similar to those reported in adult subjects with Crohn's disease in Studies CD-1, CD-2, and CD-3 [see Clinical Studies (14.4) ] . Other adverse reactions reported in at least 10% of pediatric subjects were upper respiratory tract infection (13% during induction and 17% during maintenance), COVID-19 (17% during maintenance), and headache (10% during maintenance). One pediatric subject discontinued treatment with Ustekinumab after developing anaphylactic shock within the first two minutes of initiation of the first intravenous infusion and was stabilized with medical intervention [see Warnings and Precautions (5.5) ]. Adult Subjects with Ulcerative Colitis The safety of Ustekinumab was evaluated in two randomized, double-blind, placebo-controlled clinical trials (UC-1 [IV induction] and UC-2 [SC maintenance]) in 960 adult subjects with moderately to severely active ulcerative colitis [see Clinical Studies (14.6) ] . The overall safety profile of Ustekinumab in subjects with ulcerative colitis was consistent with the safety profile seen across all approved indications. Adverse reactions reported in at least 3% of Ustekinumab-treated subjects and at a higher rate than placebo were: Induction (UC-1): nasopharyngitis (7% vs 4%). Maintenance (UC-2): nasopharyngitis (24% vs 20%), headache (10% vs 4%), abdominal pain (7% vs 3%), influenza (6% vs 5%), fever (5% vs. 4%), diarrhea (4% vs 1%), sinusitis (4% vs 1%), fatigue (4% vs 2%), and nausea (3% vs 2%). Infections In subjects with ulcerative colitis, serious or other clinically significant infections included gastroenteritis and pneumonia. In addition, listeriosis and ophthalmic herpes zoster were reported in one subject each [see Warnings and Precautions (5.1) ] . Malignancies With up to one year of treatment in the ulcerative colitis clinical trials, 0.4% of Ustekinumab-treated subjects (0.48 events per hundred patient-years) and 0.0% of subjects receiving placebo (0.00 events per hundred patient-years) developed non-melanoma skin cancer. Malignancies other than non-melanoma skin cancers occurred in 0.5% of Ustekinumab-treated subjects (0.64 events per hundred patient-years) and 0.2% of subjects receiving placebo (0.40 events per hundred patient-years) [see Warnings and Precautions (5.4) ] . Pediatric Subjects with Ulcerative Colitis The safety of Ustekinumab was assessed in 112 pediatric subjects (3 to 17 years of age) with moderately to severely active ulcerative colitis and 54 subjects received the recommended maintenance dosage [see Clinical Studies (14.7) ] . In general, adverse reactions reported in the clinical trial of pediatric subjects with ulcerative colitis were similar to those reported in adult subjects with ulcerative colitis in Studies UC-1 and UC-2 [see Clinical Studies (14.6) ] . One pediatric subject experienced worsening of preexisting peripheral neuropathy during treatment with Ustekinumab, resulting in hospitalization. 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of Ustekinumab. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Ustekinumab exposure. Immune system disorders: Hypersensitivity reactions (e.g., anaphylaxis, angioedema, dyspnea, rash, urticaria), including a fatal case that presented with chest tightness and dyspnea during infusion of the first dose. Some cases of serious hypersensitivity reactions have been reported in patients with a history of alpha-gal syndrome, allergy to mammalian meat or meat products, or anti-alpha-gal IgE. In most of these cases the reactions occurred at the time of initial administration. Infections and infestations: Lower respiratory tract infection (including opportunistic fungal infections and tuberculosis). Neurological disorders: Posterior Reversible Encephalopathy Syndrome (PRES) . Respiratory, thoracic, and mediastinal disorders: Interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia. Skin reactions: Pustular psoriasis, erythrodermic psoriasis, hypersensitivity vasculitis.

<table width="80%"><caption>Table 9: Adverse Reactions, Reported by &#x2265;1% of Subjects with Plaque Psoriasis and at Higher Rates in the Ustekinumab Groups through Week 12 in Ps STUDY 1 and Ps STUDY 2</caption><col width="45%" align="left" valign="middle"/><col width="18%" align="center" valign="middle"/><col width="18%" align="center" valign="middle"/><col width="19%" align="center" valign="middle"/><thead><tr><th/><th/><th colspan="2">Ustekinumab</th></tr><tr styleCode="Botrule"><th/><th>Placebo</th><th>45 mg</th><th>90 mg</th></tr></thead><tbody><tr><td><content styleCode="bold">Subjects treated</content></td><td><content styleCode="bold">665</content></td><td><content styleCode="bold">664</content></td><td><content styleCode="bold">666</content></td></tr><tr><td> Nasopharyngitis</td><td>51 (8%)</td><td>56 (8%)</td><td>49 (7%)</td></tr><tr><td> Upper respiratory tract infection</td><td>30 (5%)</td><td>36 (5%)</td><td>28 (4%)</td></tr><tr><td> Headache</td><td>23 (3%)</td><td>33 (5%)</td><td>32 (5%)</td></tr><tr><td> Fatigue</td><td>14 (2%)</td><td>18 (3%)</td><td>17 (3%)</td></tr><tr><td> Back pain</td><td>8 (1%)</td><td>9 (1%)</td><td>14 (2%)</td></tr><tr><td> Dizziness</td><td>8 (1%)</td><td>8 (1%)</td><td>14 (2%)</td></tr><tr><td> Pharyngolaryngeal pain</td><td>7 (1%)</td><td>9 (1%)</td><td>12 (2%)</td></tr><tr><td> Pruritus</td><td>9 (1%)</td><td>10 (2%)</td><td>9 (1%)</td></tr><tr><td> Injection site erythema</td><td>3 (&lt;1%)</td><td>6 (1%)</td><td>13 (2%)</td></tr><tr><td> Myalgia</td><td>4 (1%)</td><td>7 (1%)</td><td>8 (1%)</td></tr><tr><td> Depression</td><td>3 (&lt;1%)</td><td>8 (1%)</td><td>4 (1%)</td></tr></tbody></table>

<table width="80%" ID="Table10"><caption>Table 10: Common Adverse Reactions Through Week 8 in Trials CD-1 and CD-2 occurring in &#x2265;3% of Ustekinumab-Treated Subjects and Higher Than Subjects Receiving Placebo</caption><col width="33%" align="left" valign="top"/><col width="33%" align="center" valign="bottom"/><col width="34%" align="center" valign="top"/><thead><tr><th/><th>Placebo N=466</th><th>Ustekinumab 6 mg/kg Single Intravenous Induction Dose N=470</th></tr></thead><tbody><tr><td>Vomiting</td><td>3%</td><td>4%</td></tr></tbody></table>

<table width="80%" ID="Table11"><caption>Table 11: Common Adverse Reactions Through Week 44 in Trial CD-3 occurring in &#x2265;3% of Ustekinumab-Treated Subjects and Higher Than Subjects Receiving Placebo</caption><col width="50%" align="left" valign="middle"/><col width="25%" align="center" valign="middle"/><col width="25%" align="center" valign="middle"/><thead><tr><th/><th valign="bottom">Placebo N=133</th><th>Ustekinumab 90 mg Subcutaneous Maintenance Dose Every 8 Weeks N=131</th></tr></thead><tbody><tr><td>Nasopharyngitis</td><td>8%</td><td>11%</td></tr><tr><td>Injection site erythema</td><td>0</td><td>5%</td></tr><tr><td>Vulvovaginal candidiasis/mycotic infection</td><td>1%</td><td>5%</td></tr><tr><td>Bronchitis</td><td>3%</td><td>5%</td></tr><tr><td>Pruritus</td><td>2%</td><td>4%</td></tr><tr><td>Urinary tract infection</td><td>2%</td><td>4%</td></tr><tr><td>Sinusitis</td><td>2%</td><td>3%</td></tr></tbody></table>