Potential adverse events with biologic response modifiers

Anti-CD 20 monoclonal antibody (rituximab) treatment for inflammatory ocular diseases

“…The most frequent adverse events are infusion reactions (30-35% with the first infusion). Patients may experience immediate infusion reactions of mild and transient character [4,[7][8][9][10][11]. Nevertheless, severe infusion reactions are uncommon and their frequency is reduced by the use of concomitant intravenous steroids.…”

“…The main concern with the use of Rituximab in the treatment of autoimmune diseases, especially when used with concomitant immunosuppressive therapy, is the high incidence of systemic infections, which can sometimes lead to fatal septicemia [9][10][11]. Variable degrees of rituximab-associated infectious risk have been reported.…”

“…Several clinical studies have demonstrated the substantial impact of rituximab for treatment of various systemic autoimmune diseases [1][2][3][4][5][6][7][8][10][11][12][13][14][15][16][17]. Evidence of therapeutic effect is also mounting for numerous autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus (SLE), Wegener's granulomatosis and anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, idiopathic thrombocytopenic purpura, multiple sclerosis and Sjogren's syndrome [4,7,[12][13][14][15].…”

“…All patients were ANA positive and negative for RF and HLA-B27 antigens. The mean age at onset of arthritis was 2.8 ± 2.4 (SD) years (range 1-8), while the mean age at onset of uveitis was 4.1 ± 3.9 (SD) years (range 1-12); the mean ocular disease duration was 16.12 years (range [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] and the mean duration of arthritis was 17.35 years (range [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26]. In six out of eight patients the ocular involvement was bilateral (total number of treated eyes : 14).…”

Oral treatment with HE3286 ameliorates disease in rodent models of rheumatoid arthritis

“…This forms the basic rationale for the broad use of newly developed biologics that selectively target the action of B cells (rituzimab) or endogenous TNF-· (infliximab, etanercept, rituximab, abatacept), in this disease. While generally efficacious (2-4), these agents are costly, cannot be administered orally (5) and are ineffective or contraindicated in certain patient populations. Similar to glucocorticoids (6), they block the inductive phase of inflammation, are powerfully immune suppressive, and prolonged usage has been associated with adverse events (7).…”