- Important Safety Information
- Patients taking Stelara face increased risk of cancer
- What is Stelara?
- Stelara: Increased Rate of Cancer
- What should I do?
- ustekinumab (Stelara, Stelara PFS)
- Stelara: A New Drug for Psoriasis
Important Safety Information
STELARA® (ustekinumab) is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:
STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.
- Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®.
- If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®.
You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.
Before starting STELARA®, tell your doctor if you:
- think you have an infection or have symptoms of an infection such as:
- fever, sweats, or chills
- muscle aches
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more often than normal
- feel very tired
- are being treated for an infection or have any open cuts.
- get a lot of infections or have infections that keep coming back.
- have TB, or have been in close contact with someone with TB.
After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL‐12) and interleukin 23 (IL‐23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA® may also be more likely to get these infections.
STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.
Serious Allergic Reactions
Serious allergic reactions can occur. Stop using STELARA® and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.
Cases of lung inflammation have happened in some people who receive STELARA® and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STELARA®.
Before receiving STELARA®, tell your doctor about all of your medical conditions, including if you:
- have any of the conditions or symptoms listed above for serious infections, cancers, or RPLS.
- ever had an allergic reaction to STELARA® or any of its ingredients. Ask your doctor if you are not sure.
- are allergic to latex. The needle cover on the prefilled syringe contains latex.
- have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA® should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before receiving STELARA® or one year after you stop receiving STELARA®.
- have any new or changing lesions within psoriasis areas or on normal skin.
- are receiving or have received allergy shots, especially for serious allergic reactions.
- receive or have received phototherapy for your psoriasis.
- are pregnant or plan to become pregnant. It is not known if STELARA® can harm your unborn baby. You and your doctor should decide if you will receive STELARA®.
- are breastfeeding or plan to breastfeed. It is thought that STELARA® passes into your breast milk.
- talk to your doctor about the best way to feed your baby if you receive STELARA®.
Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
When prescribed STELARA®:
- Use STELARA® exactly as your doctor tells you to.
- STELARA® is intended for use under the guidance and supervision of your doctor. In children 12 years and older, it is recommended that STELARA® be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA® at home, you should receive training on the right way to prepare and inject STELARA®. Your doctor will determine the right dose of STELARA® for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA® yourself until you or your caregiver have been shown how to inject STELARA® by your doctor or nurse.
Common side effects of STELARA® include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.
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Patients taking Stelara face increased risk of cancer
What is Stelara?
Stelara (ustekinumab) is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation.
Stelara is used to treat plaque psoriasis in adults and children who are at least 12 years old. It is also used to treat psoriatic arthritis in adults and is sometimes given with another medicine called methotrexate.
Stelara is also used in adults to treat moderate to severe Crohn’s disease after other medicines have been tried without success.
Stelara: Increased Rate of Cancer
In 2016, the Institute of Safe Medication Practices (ISMP) analyzed the adverse effects reported to the U.S. Food and Drug Administration (FDA) in relation to Stelara and other psoriasis drugs. The findings suggested that patients who took Stelara faced an even higher risk of cancer compared to those using other medications. In fact, the rate of cancer among patients using Stelara was 15 times higher than those taking another psoriasis treatment, Otezla, which does not have an immunosuppressant effect. Patients taking other immunosuppressant drugs, Enbrel, Remicade, and Humira, were only 5 times more likely to develop cancer compared to Otezla users.
What should I do?
If you or a loved one have experienced adverse effects from taking Stelara, we are here to help. We welcome the opportunity to talk to you about your concerns and experience. Contact us by calling 303-861-8800, or by filling out the contact form below.
Stelara is the brand-name form of the generic drug ustekinumab, used to treat severe plaque psoriasis, a condition in which red, scaly patches form on the skin, and psoriatic arthritis, a form of arthritis that affects some people who have psoriasis.
The drug is typically prescribed only when topical medications alone aren’t successful in treating these conditions.
It’s also used to treat Crohn’s disease, a chronic digestive disorder.
Stelara belongs to a class of drugs called monoclonal antibodies. It works by reducing the action of certain substances in the body that can cause inflammation.
The Food and Drug Administration (FDA) approved Stelara in 2009. It’s manufactured by Janssen Biotech Inc.
Stelara may limit your body’s ability to fight infections, and raise your risk of developing a serious or life-threatening infection.
Tell your doctor if you have any type of infection or are prone to getting infections.
Try to avoid being around people who are sick or have infections while taking this medicine.
Let your doctor know right away if you experience any of the following symptoms while taking Stelara:
- Fever, chills, or night sweats
- Sore throat
- Muscle aches
- Shortness of breath
- Diarrhea or stomach pain
- Painful, burning, or difficult urination
- Painful skin sores
- Skin redness or warmth
- Other signs of infection
Stelara may raise your risk of developing tuberculosis (TB).
Tell your doctor if you have ever had TB, been in a country where TB is prevalent, or have been in contact with someone having active TB.
Your doctor will perform a skin or blood test to check for TB before starting you on Stelara.
Call your doctor immediately if you develop any of the following symptoms:
- Chest pain
- Cough or coughing up blood or mucus
- Extreme weakness or tiredness
- Loss of appetite or weight loss
Tell your healthcare provider you’re taking Stelara before having any type of surgery, including a dental procedure.
Be sure to let your doctor know about all vaccinations you’ve had. Don’t receive any vaccines while taking this medicine without first talking to your doctor.
In particular, you shouldn’t receive the BCG vaccine for one year prior to starting on Stelara, during your treatment, or for one year after your treatment with Stelara ends.
Stelara may reduce the activity of your immune system and raise your risk of developing certain cancers.
Some people who have taken Stelara have developed skin cancer (non-melanoma varieties), but these people may have already been at high risk for skin cancer. Talk to your doctor about this possibility.
Before receiving Stelara, tell your doctor if you have, or have ever had:
- Any type of cancer
- Phototherapy (an ultraviolet light treatment)
- A history of infections
- Allergies to medications, or a latex allergy
- Allergy shots
- New or changing skin lesions
Your doctor will order frequent tests to monitor your body’s response to Stelara. Keep all appointments with your doctor’s office and laboratory while taking this drug.
Pregnancy and Stelara
Stelara isn’t believed to harm an unborn baby.
Still, talk to your doctor if you’re pregnant or might become pregnant during your treatment.
The medicine passes into breast milk and may hurt a breastfeeding baby. Don’t breastfeed while taking Stelara.
The following serious adverse reactions are discussed elsewhere in the label:
- Hypersensitivity Reactions
- Reversible Posterior Leukoencephalopathy Syndrome
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 STELARA® in 3117 adult psoriasis subjects, 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 4 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the STELARA® groups than the placebo group during the placebo-controlled period of Ps STUDY 1 and Ps STUDY 2 .
Table 4: Adverse Reactions Reported by ≥1% of Subjects through Week 12 in Ps STUDY 1 and Ps STUDY 2
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 RPLS occurred during clinical studies .
In the placebo-controlled period of clinical studies of psoriasis subjects (average follow-up of 12.6 weeks for placebo-treated subjects and 13.4 weeks for STELARA®-treated subjects), 27% of STELARA®-treated subjects reported infections (1.39 per subject-year of follow-up) compared with 24% of placebo-treated subjects (1.21 per subject-year of follow-up). Serious infections occurred in 0.3% of STELARA®-treated subjects (0.01 per subject-year of follow-up) and in 0.4% of placebo-treated subjects (0.02 per subject-year of follow-up) .
In the controlled and non-controlled portions of psoriasis clinical studies (median follow-up of 3.2 years), representing 8998 subject-years of exposure, 72.3% of STELARA®-treated subjects reported infections (0.87 per subject-years of follow-up). Serious infections were reported in 2.8% of subjects (0.01 per subject-years of follow-up).
In the controlled and non-controlled portions of psoriasis clinical studies (median follow-up of 3.2 years, representing 8998 subject-years of exposure), 1.7% of STELARA®-treated subjects reported malignancies excluding non-melanoma skin cancers (0.60 per hundred subject-years of follow-up). Non-melanoma skin cancer was reported in 1.5% of STELARA®-treated subjects (0.52 per hundred subject-years of follow-up) . The most frequently observed malignancies other than non-melanoma skin cancer during the clinical studies were: prostate, melanoma, colorectal and breast. Malignancies other than non-melanoma skin cancer in STELARA®-treated patients during the controlled and uncontrolled portions of studies were similar in type and number to what would be expected in the general U.S. population according to the SEER database (adjusted for age, gender and race).1
Adolescent Subjects With Plaque Psoriasis
The safety of STELARA® was assessed in a study of 110 subjects 12 to 17 years of age with moderate to severe plaque psoriasis. The safety profile in these subjects through Week 60 was similar to the safety profile from studies in adults with plaque psoriasis.
The safety of STELARA® was assessed in 927 patients in two randomized, double-blind, placebo-controlled studies in adult patients with active psoriatic arthritis (PsA). The overall safety profile of STELARA® in patients with PsA was consistent with the safety profile seen in adult psoriasis clinical studies. A higher incidence of arthralgia, nausea, and dental infections was observed in STELARA®-treated patients when compared with placebo-treated patients (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 studies.
The safety of STELARA® was assessed in 1407 patients with moderately to severely active Crohn’s disease (Crohn’s Disease Activity Index greater than or equal to 220 and less than or equal to 450) in three randomized, double-blind, placebo-controlled, parallel-group, multicenter studies. These 1407 patients included 40 patients who received a prior investigational intravenous ustekinumab formulation but were not included in the efficacy analyses. In Studies CD-1 and CD-2 there were 470 patients who received STELARA® 6 mg/kg as a weight-based single intravenous induction dose and 466 who received placebo . Patients who were responders in either Study CD-1 or CD-2 were randomized to receive a subcutaneous maintenance regimen of either 90 mg STELARA® every 8 weeks, or placebo for 44 weeks in Study CD-3. Patients in these 3 studies may have received other concomitant therapies including aminosalicylates, immunomodulatory agents , oral corticosteroids (prednisone or budesonide), and/or antibiotics for their Crohn’s disease .
The overall safety profile of STELARA® was consistent with the safety profile seen in the adult psoriasis and psoriatic arthritis clinical studies. Common adverse reactions in Studies CD-1 and CD-2 and in Study CD-3 are listed in Tables 5 and 6, respectively.
Table 5: Common adverse reactions through Week 8 in Studies CD-1 and CD-2 occurring in ≥3% of STELARA®-treated patients and higher than placebo
6 mg/kg single intravenous induction dose
Table 6: Common adverse reactions through Week 44 in Study CD-3 occurring in ≥3% of STELARA®-treated patients and higher than placebo
90 mg subcutaneous maintenance dose every 8 weeks
|Injection site erythema||0||5%|
|Vulvovaginal candidiasis/mycotic infection||1%||5%|
|Urinary tract infection||2%||4%|
In patients with Crohn’s disease, serious or other clinically significant infections included anal abscess, gastroenteritis, and pneumonia. In addition, listeria meningitis and ophthalmic herpes were reported in one patient each.
With up to one year of treatment in the Crohn’s disease clinical studies, 0.2% of STELARA®-treated patients (0.36 events per hundred patient-years) and 0.2% of placebo-treated patients (0.58 events per hundred patient-years) developed non-melanoma skin cancer. Malignancies other than non-melanoma skin cancers occurred in 0.2% of STELARA®-treated patients (0.27 events per hundred patient-years) and in none of the placebo-treated patients.
Hypersensitivity Reactions Including Anaphylaxis
In CD studies, two patients reported hypersensitivity reactions following STELARA® administration. One patient experienced signs and symptoms consistent with anaphylaxis (tightness of the throat, shortness of breath, and flushing) after a single subcutaneous administration (0.1% of patients receiving subcutaneous STELARA®). In addition, one patient experienced signs and symptoms consistent with or related to a hypersensitivity reaction (chest discomfort, flushing, urticaria, and increased body temperature) after the initial intravenous STELARA® dose (0.08% of patients receiving intravenous STELARA®). These patients were treated with oral antihistamines or corticosteroids and in both cases symptoms resolved within an hour.
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to ustekinumab in the studies described below with the incidence of antibodies to other products may be misleading.
Approximately 6-12.4% of subjects treated with STELARA® in psoriasis and psoriatic arthritis clinical studies developed antibodies to ustekinumab, which were generally low-titer. In Crohn’s disease clinical studies, less than 3% of patients treated with STELARA® developed antibodies to ustekinumab. In psoriasis clinical studies, antibodies to ustekinumab were associated with reduced or undetectable serum ustekinumab concentrations and reduced efficacy. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen. In psoriasis studies, the majority of patients who were positive for antibodies to ustekinumab had neutralizing antibodies.
The following adverse reactions have been reported during post-approval of STELARA®. 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 STELARA® exposure.
Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria) .
Respiratory, thoracic and mediastinal disorders: Interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia .
Skin reactions: Pustular psoriasis, erythrodermic psoriasis.
Read the entire FDA prescribing information for Stelara (Ustekinumab)
ustekinumab (Stelara, Stelara PFS)
What should I discuss with my health care provider before using ustekinumab (Stelara, Stelara PFS)?
You should not use ustekinumab if you are allergic to it, or if you have:
- active tuberculosis; or
- if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.
Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
Tell your doctor if you have ever had:
- signs of infection (fever, chills, cough, muscle aches, painful skin sores, diarrhea, pain when you urinate, feeling very tired);
- chronic infections;
- new or changing skin lesions;
- a latex allergy;
- phototherapy (light therapy);
- allergy shots; or
- if you recently received or are scheduled to receive any vaccine.
Some people using ustekinumab have developed skin cancer (non-melanoma). However, these people may have had a higher risk of skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ustekinumab on the baby.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
How should I use ustekinumab (Stelara, Stelara PFS)?
Before you start treatment with ustekinumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You must remain under the care of a doctor while you are receiving ustekinumab.
Ustekinumab is injected under the skin, or as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Do not use ustekinumab if you don’t understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.
Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.
Your care provider will show you the best places on your body to inject ustekinumab. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Avoid injecting the medicine into skin that is red, bruised, swollen, or tender.
Ustekinumab doses are based on weight. Your dose needs may change if you gain or lose weight.
Call your doctor if you have any signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling constantly tired.
You will need frequent medical tests.
Each prefilled syringe or single-use vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.
Store in the refrigerator. Protect from light. Do not freeze and not shake the medicine. Store ustekinumab vials in an upright position.
Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
Psoriasis causes the top layer of skin cells to become inflamed and grow too quickly and flake off. See Answer
Stelara: A New Drug for Psoriasis
After she was diagnosed with psoriasis in 1992, at the age of 17, Sherrina Navani tried just about “everything and anything”—natural remedies, topical treatments, prescription drugs such as methotrexate—to heal the cracking, bleeding plaques that covered 90% of her body. Nothing worked.
Then, in 2006, the 32-year-old from Jersey City enrolled in a clinical trial for ustekinumab, a then-experimental biologic medication for psoriasis that has since been approved by the U.S. Food and Drug Administration (FDA) under the name Stelara. Her skin cleared within a month, but after two-and-a-half years on the injectable drug, she learned that she was pregnant with her second daughter and had to quit the study. (Like most biologics used for psoriasis, Stelara has not been tested in pregnant women and therefore the risks to the fetus are unknown.) Her psoriasis returned “full blown,” she says.
In September 2009, two months after her baby was born, Stelara was approved by the FDA, and in November Navani began using it again.
“I took my first shot and I started feeling relief in a week,” says Navani, the founder of NewYorkMother.com. Her skin is now 95% clear.
Stelara, the newest biologic for psoriasis, is a powerful drug that is approved only for moderate to severe cases of plaque psoriasis, an immune system disorder that causes red, inflamed skin lesions, often covered with silvery scales.
Stelara gives hope to hard-to-treat patients like Navani, and because it has a different mechanism of action, its especially promising for patients who havent responded, or have stopped responding, to other biologics.
“This is a drug where you give a shot and four weeks later the patients know theyre getting better, almost to a person,” says the chairman of the medical board of the National Psoriasis Foundation, Mark G. Lebwohl, MD, who helped recruit patients for many of the clinical trials of Stelara. “It is so uniformly effective and so dramatically effective that the results are quite spectacular.”
Despite the positive early reviews, experts caution that Stelara, like all biologics, has the potential to bring harm as well as relief. The drug carries a small risk of serious side effects, and, because its new, its safety in the long term is still unclear.
A new weapon to fight psoriasis
Biologics are the newest generation of psoriasis medications. Unlike older prescription drugs for psoriasis, which are made from synthetic chemicals and are taken orally, biologics are made from bioengineered human or animal proteins and are delivered via injection or IV. They work by blocking the action of certain immune cells or chemical messengers that play a role in psoriasis.
Before Stelara, there were two classes of biologics. The first class, known as TNF blockers (or inhibitors), targets proteins in the immune system and includes drugs such as Enbrel (etanercept) and Humira (adalimumab). The second contains just one drug, Amevive (alefacept), which works by blocking the white blood cells known as T cells.
One of Stelaras main selling points is that it has a different mechanism of action than the other biologics on the market. “The TNF inhibitors were a huge step forward but yet there were even some people who didnt get better with those drugs,” says Steven R. Feldman, MD, PhD, a professor of dermatology at Wake Forest University Health Sciences, in Winston-Salem, N.C. “ we have yet one more tool.”
Next Page: Less frequent injections
In some psoriasis patients, biologics gradually (and sometimes suddenly) stop working. Stelaras unique mechanism of action makes it a good alternative for these patients, as switching to another biologic is often successful in such cases.
“If a patient comes in and theyve never been on a biologic before, Im prescribing a TNF for them,” says Craig Leonardi, MD, a clinical assistant professor of dermatology at St. Louis University and private practice dermatologist in St. Louis. ”But if theyve failed Enbrel? Arent doing well on Humira? Thats a Stelara kind of patient, absolutely. Theyve done their hard time. Theres a reason to be using the drug.”
Another major difference between Stelara and older biologics is that the drug needs to be injected less frequently. Patients on Stelara receive a pair of initial shots four weeks apart, then an additional shot every 12 weeks. Other biologics are given as often as every other week, weekly, or twice a week.
Is Stelara safe?
Patients can achieve dramatic results with biologics, but the drugs have been hounded by safety concerns. Biologics work by suppressing the immune system, which can make patients more susceptible to infections, ranging from the flu to tuberculosis. As with other biologics, patients should undergo testing for tuberculosis before starting Stelara, and while taking the drug they should be tested for TB once a year.
Despite the potential for serious complications inherent to biologics, the side effects of Stelara generally include little more than upper respiratory tract infections (such as the common cold), fatigue, and minor body aches. “So far its been well tolerated,” says Dr. Leonardi.
The long-term safety of the drug remains unknown, however.
“Stelara is new, its high performance, it looks good, and it serves most well, but its not a first-line drug for me yet,” says Dr. Leonardi. “Whats missing right now is experience.” While TNF blockers have been used for more than a decade to treat arthritis (like psoriasis, an inflammatory condition), Stelara has been widely tested in clinical trials for just a few years, he says.
Biologics, moreover, have been linked to some scary side effects, even after FDA approval. In the spring of 2009, the maker of a biologic known as Raptiva voluntarily withdrew the drug from the market following reports of a rare but deadly brain infection. Then, in August, the FDA announced that it would require all TNF blockers to carry a so-called black-box warning stating that the drugs cause an increased risk of lymphoma and other cancers in children and adolescents.
Dr. Feldman tends to err on the side of safety. “If it were me, I would probably choose one of the drugs where we have a longer safety experience,” he says. But because “different people put their risks in different barrels,” he urges his patients to be involved in the decision-making process.
“Some people, you know, they smoke, they drive fast, and they want their psoriasis gone right away. They want the most powerful thing. Theyre not so worried about safety risk,” he says. “Other people are just the opposite. Theyre like, ‘I dont care how long it takes; I just want to be safe in how we treat this.”
Navani was aware of the potential cancer and immune system risks when she began taking Stelara, and although she says that “you never want to give up one problem for another,” she decided that alleviating the pain and embarrassment of her condition was worth the risk.
Will my insurance cover it?
Like many high-powered drugs, Stelara is expensive. The list price for one 45-milligram dose is $4,663, which has given some insurance companies pause.
A few dermatologists say insurers are requiring patients to try (and fail) an oral medication such as methotrexate and an older biologic before they will agree to cover a Stelara prescription. “Stelaras a little bit more expensive than the other biologics, and that may be the reason that theyre requiring that they fail one of the older ones,” says Dr. Lebwohl, who is also the chairman of the department of dermatology at the Mount Sinai School of Medicine, in New York City.
Brian Kenney, a spokesman for the drugs manufacturer, Centocor Ortho Biotech, says that few insurers have decided how to cover Stelara because its still so new. In the meantime, he says, the company is helping eligible patients who have commercial insurance with their out-of-pocket costs and will also provide referrals to those who may qualify for various patient-assistance programs.