Infliximab (Remicade):10 Infusion
Biosimilar(s): infliximab-dyyb (Inflectra),11 infliximab-abda (Renflexis),12
infliximab-qbtx (Ixifi)13
Drug class: DMARD, TNFi
Boxed warning: Refer to *ISI (left) and
- Fatal hepatosplenic T-cell lymphoma (HSTCL) has been reported in patients treated with TNFi’s, post-marketing. All infliximab cases occurred in inflammatory bowel disease (IBD) patients, who were mostly adolescent or young adult males. All had received azathioprine or 6-mercaptopurine concomitantly with infliximab at or prior to diagnosis.
Warnings & Precautions
- Do not give infliximab during an active infection. If an infection develops, monitor carefully and stop infliximab if infection becomes serious.
- Invasive fungal infections have occurred. For patients who develop a systemic illness on infliximab, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic.
- The incidence of malignancies including lymphoma was greater in infliximab-
treated patients than in controls. Due to the risk of HSTCL, carefully assess the risk/benefit especially in Crohn’s disease (CD) or ulcerative colitis patients, in males, and if receiving azathioprine or 6-mercaptopurine treatment. - Hepatitis B virus (HBV) reactivation can occur. Therefore, test for HBV infection before starting infliximab. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop infliximab and begin anti-viral therapy.
- Hepatotoxicity—rare severe hepatic reactions, some fatal or necessitating liver transplantation—have occurred. Stop infliximab in cases of jaundice and/or marked liver enzyme elevations.
- Heart failure—new onset or worsening symptoms may occur.
- Cytopenias have occurred. Advise patients to seek immediate medical attention if signs and symptoms develop, and consider stopping infliximab.
- Hypersensitivity—serious infusion reactions, including anaphylaxis, or serum sickness-like reactions may occur.
- Demyelinating disease—exacerbation or new onset may occur.
- Lupus-like syndrome—stop infliximab if the syndrome develops.
- Live vaccines or therapeutic infectious agents should not be given with infliximab.
Commentary: The FDA approved infliximab for treatment of active PsA based on data from two clinical trials that showed positive results. The most common adverse reactions (≥10%) are infections (e.g., upper respiratory, sinusitis, pharyngitis), infusion-related reactions, headache and abdominal pain.
Adalimumab (Humira):14 Injection
Biosimilars: adalimumab-atto (Amjevita),15 adalimumab-adbm (Cyltezo),16 adalimumab-adaz (Hyrimoz)17
Drug class: DMARD, TNFi
Boxed warning: Refer to *ISI (left) and
- Fatal hepatosplenic T-cell lymphoma (HSTCL) have occurred postmarketing in adolescent and young adults IBD patients treated with TNFi’s.
Warnings & Precautions
- Do not start adalimumab during an active infection. If an infection develops, monitor carefully, and stop adalimumab if the infection becomes serious.
- Invasive fungal infections—For patients who develop a systemic illness on adalimumab, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic.
- The incidence of malignancies was greater in adalimumab-treated patients than in controls.
- Anaphylaxis or serious allergic reactions may occur.
- HBV reactivation can occur. Monitor HBV carriers during and for several months after therapy. If reactivation occurs, stop adalimumab and begin anti-viral therapy.
- Demyelinating disease, exacerbation or new onset, may occur.
- Cytopenias, pancytopenia—advise patients to seek immediate medical attention if symptoms develop, and consider stopping adalimumab.
- Heart failure, worsening or new onset, may occur.
- Lupus-like syndrome—stop adalimumab if the syndrome develops.
Commentary: Adalimumab received an expanded indication based on results from a clinical trial of 313 patients with moderate to severe PsA who had an inadequate response to NSAIDs. Patients taking adalimumab experienced significantly less joint damage than patients taking placebo, and nearly 60% of patients achieved an ACR 20 response through Week 24.The most common adverse reactions (≥10%) are infections (e.g., upper respiratory, sinusitis), injection-site reactions, headache and rash.