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Content Update

April 18, 2018

American College of Rheumatology White Paper on Biosimilars: The American College of Rheumatology (ACR) published a white paper that reviews the scientific, clinical, economic, and prescribing issues related to use of biosimilars. A "biosimilar" is a biologic product that is highly similar to an approved reference (or originator) biologic product and has no clinically meaningful differences in efficacy, adverse effects, or immunogenicity compared to the reference product. Based on the outcomes of rigorous regulatory requirements, the ACR white paper asserts that patients and healthcare providers should have confidence that an approved biosimilar should produce clinical outcomes comparable to those achieved with its reference product. The paper encourages healthcare providers to incorporate biosimilars into their practices where appropriate with the goal of continued delivery of high-quality health care at lower cost to individual patients.


Patient Care Process for Treatment of Inflammatory Bowel Disease



  • Patient characteristics (e.g., age, sex, weight, vital signs, etc.)

  • Patient symptoms, including evidence of abdominal pain, stool frequency, presence of hematochezia, weight loss, or extraintestinal manifestations

  • Patient medical, family, and social history (in particular tobacco use)

  • Surgical operations (site, date, procedure) and abdominal imaging findings (CT, MRI, ultrasound)

  • Thorough medication history at hospital admission (include prescription, non-prescription medications and other substances), and drug allergies and intolerances.

  • Laboratory results for evidence of inflammation (CRP, ESR, WBC), major organ function (particularly kidney and liver), hemoglobin and hematocrit, nutritional status (serum albumin and transferrin), vaccination status, pregnancy status, and pANCA or anti-Saccharomyces cerevisiae antibodies if initial diagnostic workup, and pharmacogenomics status for TPMT, if applicable.


  • Determine severity of illness based on symptoms, vital signs, stool frequency, and inflammatory markers. Consider use of Crohn's Disease Activity Index to assess disease progress. Include assessment of fluid and electrolyte status.

  • Determine extent and location of inflammation in the gastrointestinal tract based on endoscopic and imaging procedures.

  • Assess if extraintestinal disease manifestations and comorbidities are present that may affect section and outcomes of medication regimens.

  • Evaluate current medication regimen for potential drug induced exacerbating factors and for efficacy and toxicity of current IBD treatment regimen.

  • Assess if disease complications are present that may require surgical intervention (abscess or fistulae)

  • Estimate creatinine clearance for drug dosing.


  • Determine goals of therapy with monitoring parameters for each goal.

  • Based on severity and location of Illness, determine the appropriate medications to induce and maintain remission considering severity and site of disease (Figures 34-2 and 34-3)

  • Initiate adjunctive medications for pain and diarrhea, if needed.

  • Check for adverse drug reactions and interactions and dose adjustments based on end-organ function (Table 34-6).


  • Initiate medications for short term induction of remission and subsequent maintenance.

  • Discontinue medications that may be exacerbating symptoms.

  • Provide patient education on appropriate use of oral, parenteral, or rectally administered medications.

  • Assure that corticosteroids doses are tapered during discontinuation.

Follow-up: Monitor and Evaluate

  • Determine if patient shows improvement in the ...

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