Patient Encounter 2

A 57-year-old African American man presents to the clinic for follow-up management of UC. He has had left-sided disease for 3 years and has been maintained in remission on maximal doses of oral mesalamine and prednisone 35 mg orally once daily. His provider has attempted several times to taper the prednisone dose, but the patient experiences a reappearance of symptoms if the dose is lowered below this level. Medical history is also significant for hypertension and heart failure. He has no known drug allergies.

What are the risks of long-term corticosteroid use in this patient?

What treatment options are available for reducing corticosteroid dependency in this patient?

What other information is needed before recommending a pharmacologic intervention?

Table 19-5 Treatment Recommendations for CD

blseaie Location »nd SwTrity

Atliiit Dim»

; cl Remission

Mild Dbieas*

Moderate Disease

Severe or Fulminant Disease

WttJUinine 32 4.8<}/tUyOf Su«ÍHU¿¡iie 4-í> qrtíjy orally

Sutfeisonidc 9 mg dally oiallyfbr up Do B weeks Hilara ine ?,il -1.S q/tlay c* fulfi«lAtfre

4-(t gvd.iy orally. May aWflíftlontdMíle lO-JOimj/tiiAJay ciprofloxacin I g daily Same Lnealment» tor mild disease; If ifi^XiquPW n-ijwn^TO ^niftCi-hliCyVue, ÍOníOct;

* Infliximab or adslimumab or cedofcmmab (we Table 19-i ÍC* duugv ne(^ni(!ni) w

* Prednisone «3-60 mcyday orally. Of

* Budesontde Í mg/day orally for up Do B weeks; » fiifhiriri i Li:.! ' i ■>.:: 11' in; ii^xwivrlci | irfc ir thaaples

If fislultwtg disease, conslcier: ■ ■ "!■■:■■- ih <.11 :■:.. . — i_■!: Hydrocortisone J0Ü mg W dally ior equivalent k 7 days, or

InfiMirn.sh (íimu1 & foTultfnq flisiwfl 5 incj/ki | IV at 0,2. and 6 weeks;

* Aii.ilinujm,)t> (X OHtOftMIHbOf

* tcmikh?r nalainuiuEi if no iwponie to prior theiapies

COf^kJír t^k^hdirií» J niiL-'IK|.'il.jw fOi ■■ li.-n lc*y disease rjocf :n«ju<riine 1.6-2.4 (yiiiyOf suiiisJViiziiie 2 4 QAJay orally

Tap« bud«onidc to 6 mg daily for up to J months

Conlinue aminosalicylate al rnainienanee dose; May torvrinijf iilüiim.iL:. ,ll niíinífrwK^tfíWí (w l¿l>)e 19-31

If kHSofiFSporHJ' lu inllisimjb.tuivydpi j(Jiliiin>ralj f^vt prednisow as seen as postule: Tape buóesomde to f> mg daily kir i months. COUidOf *3difitp ^jlhicfirilie Of 6 i'? 1 ,i is rii j/ki ^Vljiy orallyor nselhctfiesate IJJJS mg cxaly at iMÁt once weetdy

[jomiilw rwrjli/umab if r>3 re^pMiv k> pievirtii il^Mpi«

Tap« oortlccKteKUd as soon as possible;

Way continue inllisimab, inJalmiumab, certcH¡¿umah,or nataltiuiriMl (W l.ilHi' T ■ } lot i |i:j„>:>- h i

Consxi?f Adding aralhioprine of-6-WI11Í-J.S mgVkivday oullym ifltthouedic Hi my o<jlly c» IW5C wri'kly

& MR e-mercapinpuiine; IM, Inhamuscular; subcutaneous.

Metronidazole or ciprofloxacin can be used in patients who do not respond to oral aminosalicylates. Response rates of up to 50% are reported, but data are conflicting, and these agents should generally not be considered first-line therapy. '

Moderate to Severe Active CD

© Patients with moderate to severe active CD may be treated with oral corticosteroids, such as prednisone 40 to 60 mg daily? Budesonide 9 mg orally once daily may be used for moderate active CD involving the terminal ileum or ascending colon.

Infliximab is an effective alternative to corticosteroid therapy for patients with

14 24 37

moderate to severe CD, including patients with fistulizing or perianal disease. ' ' The recommended regimen for induction of remission is infliximab 5 mg/kg at weeks 0, 2, and 6; it is effective in inducing remission in approximately 80% of patients at 8 weeks. Complete closure of existing enterocutaneous fistulae occurs in approximately 50% of patients.

Adalimumab is effective in moderate to severe active CD and is used preferably in patients with diminished response to infliximab. The approved adult dose of 160 mg on day 1, 80 mg at 2 weeks, and 40 mg at day 29 resulted in a remission rate of 36% at 4 weeks.16,38

Certolizumab is also effective, with a dose of 400 mg subcutaneously initially, and then at 2 and 4 weeks resulting in a clinical response rate of 37% at 6 weeks.16,38 Natalizumab 300 mg IV every 4 weeks has been reported to induce remission in up to 37% of patients at 10 weeks, which was similar to placebo.16,38

For patients with simple perianal fistulae, antibiotics, infliximab, or adalimumab are appropriate treatment options. Complex perianal fistulae are those associated with multiple openings, abscess, stricture, or penetration into the vaginal wall. These types of perianal fistulae may require surgical intervention but may also be amenable to treatment with antibiotics, infliximab, azathioprine, or 6-MP.2,15,16,23

Severe to Fulminant Active CD

Most patients with severe to fulminant CD require hospitalization for appropriate treatment. Patients should be assessed for possible surgical intervention if abdominal distention, masses, abscess, or obstruction are present. Daily IV doses of corticosteroids equivalent to prednisone 40 to 60 mg are recommended as initial therapy to rapidly suppress severe inflammation.

If there are no contraindications, infliximab 5 mg/kg followed by 5 mg/kg at weeks 2 and 6 may be used for severe active CD. There is no evidence that infliximab is either safe or effective for fulminant disease. Adalimumab or certolizumab are also options for patients with severe CD, particularly those who have lost response to in-fliximab or those who are nonresponsive to traditional therapies. Natalizumab can be used for severe CD but is reserved for patients failing other available therapies, including TNF-a inhibitors.

Adjunctive therapy with fluid and electrolyte replacement should be initiated. Nutritional support with enteral or parenteral nutrition may be indicated for patients unable to eat for more than 5 to 7 days.2 Some evidence suggests that enteral nutrition provides anti-inflammatory effects in patients with active CD.39,40

Limited evidence indicates that cyclosporine, or possibly tacrolimus, may be ef-

2,23

fective as salvage therapy for patients who fail IV corticosteroid therapy. ' Surgical intervention may ultimately be necessary for medically refractory disease.

Maintenance of Remission in CD

Patients with CD are at high risk for disease relapse after induction of remission. Within 2 years, up to 80% of patients suffer a relapse; therefore, most patients should be evaluated for indefinite maintenance therapy. Maintenance of remission of CD may be achieved with oral or topical aminosalicylate derivatives, immunosuppress-ants (such as azathioprine, 6-MP, and methotrexate), or infliximab, adalimumab, cer-tolizumab, or natalizumab.

In contrast to their use in UC, sulfasalazine and the newer aminosalicylates are marginally effective in preventing CD relapse in patients with medically induced remission, with success rates of only 10% to 20% at 1 year.26 Nevertheless, aminosalicylates are routinely used to maintain remission of CD. Some evidence does exist that the aminosalicylates may prevent or delay disease recurrence in patients with surgically induced remisson.2,26

Several other treatment options exist for maintaining remission that may also reduce the need for corticosteroids. Infliximab has been shown to maintain remission in 46% of patients compared to 23% of those treated with placebo over a 54-week 15 23 38

period. ' ' Adalimumab 40 mg subcutaneously given every other week has been

15 38

shown to maintain remission in up to 36% of patients at 56 weeks of treatment. '

Certolizumab 400 mg IV every 4 weeks has also been effective in maintaining remis-

15,38

sion in up to 61% of patients at 26 weeks. ' Patients with a baseline CRP of greater than 10 mg/L may have a more favorable response. Natalizumab may also be used for maintenance in patients unresponsive to anti-TNF-a agents. Up to 40% of patients

15 38

may maintain remission at 15 months. '

Azathioprine and 6-MP in oral doses up to 2.5 mg/kg/day have been shown to maintain remission in 45% of patients for up to 5 years.2,2 ,25,26 These drugs may be used to prevent disease recurrence after surgically induced remission. Methotrexate in doses ranging from 12.5 to 25 mg/week given orally, intramuscularly, or subcu-taneously has resulted in remission rates of up to 52% at 3 years.26,27

Corticosteroids, while effective for inducing remission rapidly, are not effective for maintenance therapy and are associated with significant adverse effects with long-term use. Therefore, systemic or topical corticosteroids should not be used for maintaining remission in patients with IBD. Unfortunately up to 50% of patients treated acutely with corticosteroids become dependent on them to prevent symptoms.

In place of conventional corticosteroids, budesonide 6 mg orally once daily may be used for up to 3 months after remission induction for mild to moderate CD.

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