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Calabrese details prevention of serious infections in patients with immune-mediated inflammatory diseases
CLEVELAND — At the Biologic Therapies VII Summit, Leonard Calabrese, DO, professor of medicine at the Cleveland Clinic and Chief Medical Editor of Healio Rheumatology, described how to prevent serious infections in patients with immune-mediated inflammatory diseases.
“The best practice is to assess the severity and the activity of the disease,” Calabrese said. “We cannot emphasize [that] enough. We are so focused on biologics and yet, study after study shows glucocorticoids are the greatest risk factor.”
Calabrese described the following as the greatest risk factors for serious infection in patients with rheumatoid arthritis (RA): RA disease severity; corticosteroid therapy; comorbidities — including chronic obstructive pulmonary disease, congestive heart failure, chronic renal failure and insulin-dependent diabetes mellitus — cutaneous breakdown; and major joint surgery.
Calabrese noted a doubling in the rate of serious infection with use of all biologics, except for etanercept (Enbrel, Amgen) and golimumab (Simponi, Janssen), which had rates equivalent to placebo.
In a selection of randomized controlled trials for rituximab, abatacept and anakinra, Calabrese noted the risk for serious infection was highest for anakinra (ratio = 2.75), followed by rituximab (ratio = 1.45) and abatacept (ratio = 1.35). For rituximab, the risk for serious infection increased for patients with low immunoglobulins both before and after rituximab use, Calabrese said.
In addition, Calabrese mentioned the risk for serious infection is highest in elderly patients. The risk for serious infection is highest during the first 3 months to 6 months of treatment and that prior infection increases the risks for infection and death.
Calabrese mentioned use of the RABBIT score to help physicians determine the infection risk for a specific patient who will take tumor necrosis factor inhibitors (TNFis).
For the risk of tuberculosis (TB), Calabrese cited a study in Arthritis & Rheumatology which found glucocorticoid use of no more than 15 mg per day had a 2.8 odds ratio and use of at least 15 mg per day had a 7.7 odds ratio.
According to a 2010 survey, 42% of rheumatologists routinely screen for hepatitis B before non-biologic disease-modifying antirheumatic drug (DMARD) administration; 69% routinely screen before biologic DMARD; and 7% observed a reactivation of hepatitis B in their patients, Calabrese said.
Calabrese mentioned patients who have active hepatitis, non-tuberculosis mycobacterial infection, invasive fungal infection or who are about to receive intravesicular Bacillus Calmette-Guerin treatment should not receive TNFi therapy.
He also listed inappropriate practices for patients who receive biologics. He cited repeated interferon gamma release assay (IGRA) for tuberculosis as annual testing as a poor practice, as the value of repeat testing during biologic therapy is not proven. He said waiting weeks between a positive Mantoux test for tuberculosis and initiation of TNFi is a poor practice, as the labelling states preventative anti-tuberculosis therapy must be started before initiation of TNFi. He said use of IGRA to supplant a surprisingly positive Mantoux test is an inappropriate practice, as either test with a positive result is enough evidence of TB infection. He mentioned progressive multifocal leukoencephalopathy screening prior to rituximab therapy has poor predictive value. In addition, he said suspension of biologic due to upper respiratory infection or cough is a poor practice as these are the most common adverse events found in randomized controlled trials.
“Rheumatologists select drugs primarily on basis of safety more than efficacy, and I think that this is good,” Calabrese said. “Make sure that you have a good infectious disease practitioner and group to collaborate with.” – by Will Offit
Reference:
Calabrese L. Preventing serious infections in IMIDs patients. Presented at: the Biologic Therapies VII Summit; April 4-8, 2017; Cleveland.
Disclosure: Calabrese reports consulting, teaching and speaking for AbbVie, Bristol-Myers Squibb, Genentech/Roche and Janssen; consulting for GlaxoSmithKline, Pfizer and UCB; and teaching and speaking for Crescendo.