View the Table: Some Drugs for Inflammatory Bowel Disease

Rheumatoid arthritis (RA) is prevalent in 0.5% of adults in the US; it is about 2.5 times more common in women than in men. Guidelines for treatment of RA from the American College of Rheumatology were recently updated. The goal of treatment is to minimize disease activity and prevent irreversible joint damage.

The FDA has approved benralizumab (Fasenra – AstraZeneca), a humanized monoclonal antibody selective for the interleukin-5 (IL-5) receptor, for add-on maintenance treatment of severe asthma in patients ≥12 years old with an eosinophilic phenotype. Benralizumab is the third anti-IL-5 antibody to be approved for treatment of severe eosinophilic asthma; mepolizumab (Nucala) and reslizumab (Cinqair), which target IL-5 itself, were approved earlier.

Tafasitamab-cxix (Monjuvi – Morphosys), a CD19-directed cytolytic antibody, has received accelerated approval from the FDA for use in combination with lenalidomide (Revlimid) for treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from low grade lymphoma, in adults who are not eligible for autologous stem cell transplant. Accelerated approval was based on overall response rates.

Prosorba, an antibody-adsorbing column used with plasmapheresis, has been approved by the FDA for treatment of moderate-to-severe rheumatoid arthritis in patients refractory or intolerant to methotrexate and other disease-modifying anti-rheumatic drugs (DMARDs).

The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old (weight ≥40 kg) who have moderate to severe immune compromise and are unlikely to respond adequately to COVID-19 vaccination (see Table 1). Pemgarda is the only drug that is currently authorized in the US for pre-exposure prophylaxis of COVID-19. Tixagevimab/cilgavimab (Evusheld) was previously available under an EUA for this indication, but it lacks activity against...

The oral sphingosine 1-phosphate (S1P) receptor modulator ozanimod (Zeposia – Bristol Myers Squibb) has been approved by the FDA for treatment of adults with moderately to severely active ulcerative colitis. It is the first S1P receptor modulator to be approved for treatment of ulcerative colitis. Ozanimod was approved in March 2020 for use in adults with relapsing forms of multiple sclerosis.

Basiliximab (Simulect - Novartis) and daclizumab (Zenapax - Roche), two mouse/human monoclonal antibodies that block the interleukin-2 (IL-2) receptor on Tlymphocytes, have been approved by the FDA for use in the prevention of acute renal transplant rejection. Both drugs are used with cyclosporine (Sandimmune; Neoral) and corticosteroids. An all-murine anti-CD3 monoclonal antibody, muromonab-CD3 (Orthoclone OKT3), has been available in the USA for many years for treatment of transplant rejection, and has also been used with some success for prophylaxis (MI Wilde and KL Goa, Drugs,...

The FDA has approved belinostat (Beleodaq – Spectrum), an IV histone deacetylase (HDAC) inhibitor, for treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is the third IV drug approved by the FDA for PTCL. The first was the antifolate drug pralatrexate (Folotyn), which was followed by the HDAC inhibitor romidepsin (Istodax). Vorinostat (Zolinza), an oral HDAC inhibitor, is FDA-approved for treatment of cutaneous T-cell lymphoma.

Eteplirsen (Exondys 51 – Sarepta), an antisense oligonucleotide, has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the dystrophin gene that is amenable to exon 51 skipping. It is the first drug to be approved for treatment of DMD.