BACKGROUND:
As the prevalence of complex inflammatory bowel disease and extraintestinal manifestations continue to rise, more patients are requiring complex treatment regimens. In some cases, patients may require more than one biologic agent to target different areas in the inflammatory cascade. Although a body of data is emerging, there is currently no consensus on patient and agent selection for dual therapy or adverse outcomes of therapy.
METHODS:
A retrospective chart review of all patients receiving dual biologic therapy for IBD at a single tertiary care center was conducted. This was exempted by the IRB. Data regarding the patient and disease course, indication for dual biologic use, other concurrent therapies, infections and any adverse events was collected from the EMR.
RESULTS:
Ten patients (9 Crohn’s Disease, 1 Ulcerative Colitis) were identified as receiving dual biologic therapy. The most common combination therapy was ustekinumab with vedolizumab (5) or an anti-TNF (4); one patient was receiving adalimumab with vedolizumab. Nine patients were also on an immunomodulator (6 methotrexate, 2 6-mercaptopurine, 1 azathioprine) and three required steroids in addition to dual biologic therapy. The majority (8) of the patients were started on dual biologic therapy due to refractory GI symptoms, the others were due to extraintestinal manifestations (EIMs) with psoriatic arthritis and ankylosing spondylitis. Nine patients had significant symptomatic improvement on dual biologic regimen and all six patients with follow-up endoscopy demonstrated improvement. Two patients developed infectious diarrhea (C.difficile and e. coli), no other significant infections were noted. No patients were found to have malignancy or any other adverse effects of treatment during the reviewed period.
CONCLUSION:
Dual biologic therapy can be used with improvement in symptomatic and endoscopic findings of IBD. The combination use of two biologic agents does not appear to have additional infectious risk compared to single agent and no other adverse events were described. Longer follow-up and larger patient populations are needed to verify the combination of biologic mechanisms for therapy of refractory IBD and EIMs.
disease-related outcomes and quality of life. A mechanism for early identification of potentially nonadherent patients in conjunction with a behavioral intervention to improve adherence has the potential to prevent the development of CD complications and decrease CD-associated morbidity.
vaccine recipients. Vaccination with a non-mRNA vaccine predicted lower antibody levels (beta: -5.90 [95% CI: -6.99 to -4.82]; P , 0.0001) and less seroconversion (Fisher's exact: P , 0.0001), whereas age, sex, body mass index, and absolute lymphocyte count (ALC) did not predict lower antibody levels in nucleocapsid antibody-negative participants. Conclusion(s): Participants receiving ozanimod developed humoral immune response to SARS-CoV-2 vaccines, with 100% seroconversion after mRNA vaccination; this was independent of demographic characteristics and ALC levels at time of vaccination. However, some participants developed low antibody concentrations and may benefit from booster doses. Fully vaccinated participants with confirmed evidence of natural infection had higher seroconversion rates and RBD antibody levels, possibly suggesting a primed immune response.
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