marketing ustekinumab use. If diagnosis is confirmed, discontinue ustekinumab and initiate appropriate treatment.
Commentary: The FDA based its approval on two randomized, controlled trials of more than 900 patients. The study participants had at least five tender and swollen joints and high levels of C-reactive protein (a measure of inflammation), and were not responding to current therapies. The most common adverse reactions (≥3%) are arthralgia and nausea.
Tofacitinib (Xeljanz/ Xeljanz XR):22 Tablets
Drug class: DMARD, JAK inhibitor
Boxed warning: Refer to *ISI (p. 17) and
- Lymphoma and other malignancies have been observed in tofacitinib-treated patients. Epstein-Barr virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with tofacitinib and concomitant immunosuppressive medications.
Warnings & Precautions
- Avoid use of tofacitinib during an active serious infection, including localized infections.
- Use with caution in patients who may be at increased risk for gastrointestinal perforations.
- Monitor laboratory parameters: lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids, due to potential changes.
- Avoid use of live vaccines with tofacitinib.
Commentary: Tofacitinib is the first and only drug of a new class of treatments called JAK inhibitors approved for the treatment of PsA. The FDA approved tofacitinib for adults with active PsA who have had an inadequate response or intolerance to methotrexate or other DMARDs. The most common adverse reactions (≥2%) are upper respiratory tract infection, nasopharyngitis, diarrhea and headache.
Brodalumab (Siliq):23 Injection
Important note: The manufacturer has completed phase 3 testing of brodalumab for psoriatic arthritis, and the drug was included in the ACR/NPF guideline. However, it is not currently approved by the FDA for this indication.
Drug class: monoclonal antibody, interleukin 17 receptor antagonist (IL17-RA)
Boxed warning: Suicidal ideation and behavior
- Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with brodalumab.
- Prior to prescribing, weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior.
- Patients with new or worsening suicidal thoughts and behavior should be referred to a mental health professional.
- Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes.
- Brodalumab is available only through a restricted program called the SILIQ REMS Program.
Warnings & Precautions
- Serious infections have occurred. Consider the risks and benefits prior to initiating brodalumab in patients with a chronic infection or a history of recurrent infection. If a serious infection develops, discontinue brodalumab until the infection resolves.
- Evaluate patients for TB prior to initiating treatment with brodalumab.
- Crohn’s disease occurred in brodalumab-
