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Table 5 Adverse events during vedolizumab therapy

From: Efficacy and safety of vedolizumab for pediatrics with inflammatory bowel disease: a systematic review

Any adverse events

No Reported Occurrences

Serious adverse events d

No Reported Occurrences

Overall

NR

Overall

10/173

Respiratory tract infectiona

15

Dehydration/vomiting

4

Nausea and vomiting

14

Flare of diseasee

3

Headache

11

Bowel-associated dermatosis–arthritis syndromefe

1

Fatigue

8

Synovitis, acne, pustulosis, hyperostosis, osteitisg

1

Mild-nonurticarial-rash

7

Obstructing nephrolithiasis and pyonephritish

1

Arthralgia/joint pain

6

Diverting ileostomyi

1

Dizziness

5

ColectomySynovitis, acne, pustulosis, hyperostosis, osteitisf

11

Skin infections

2

Severe systemic allergic reactionObstructing nephrolithiasis and pyonephritisg

11

Dermatitis and rhinitis

2

Septic arthritisjDiverting ileostomyh

11

Erythema nodosum

2

Deep vein thrombosiskColectomy

11

Allergic reactionb

2

Severe systemic allergic reaction

1

Otitis externa

1

Septic arthritisi

1

Periorbital oedema

1

Deep vein thrombosisj

1

Intractable itch

1

  

New perianal disease

1

  

Septic arthritis

1

  

Deep vein thrombosis

1

  

Cholangitisc

   

Isolated cases of paraesthesia

1

  

Alopecia

1

  

Anaemia

1

  

Herpes zoster

1

  

Impetigo

1

  
  1. Abbreviations: NR no exact number reported (Conrad et al. (2016) [23]  and Garcia-Romero et al. (2021) [30] didn’t report number of patients who had adverse events)
  2. aincludes upper respiratory tract infection, nasopharyngitis, sinusitis
  3. bincludes mild shortness of breath and general systemic allergic reaction with dyspnoea
  4. cThe patient had a history of primary sclerosing cholangitis and had ascending cholangitis while on vedolizumab therapy
  5. dincludes requiring hospitalization or vedolizumab discontinued
  6. e3 patients developed new extraintestinal manifestations of IBD, of which 2 subjects had new onset erythema nodosum, and 1 subject developed bowel-associated dermatosis–arthritis syndrome
  7. fThe subject who had diverting ileostomy due to severe perianal disease, developed bowel-associated dermatosis–arthritis syndrome and was treated with antibiotics and corticosteroids with subsequent resolution of symptoms and continued on vedolizumab without further recurrence of these manifestations
  8. gThe subject who initially had erythema nodosum, later developed synovitis, acne, pustulosis, hyperostosis, and osteitis syndrome, characterized by dermatologic and osteoarticular findings without clear etiology that has been associated with IBD in previous case reports
  9. hThe subject with CD, who had a history of recurrent acute kidney injury due to hypovolemia with disease flares, developed obstructing nephrolithiasis with associated pyonephritis, then underwent drainage and ureteral stent placement as well as intravenous antibiotic treatment, and was continued on vedolizumab achieving remission without further kidney involvement
  10. iThe subject with CD, who had worsening symptoms and distal colonic inflammation, required a diverting ileostomy
  11. jThe subject with UC treated with the combination of vedolizumab 300 mg every 8 weeks and tofacitinib 10 mg twice daily, in addition to prednisone 30 mg daily, developed septic arthritis of the right knee 2 months after dual therapy initiation, requiring inpatient hospitalization with incision and drainage and a prolonged course of intravenous antibiotic therapy
  12. kThe subject above subsequently developed a deep vein thrombosis in the right leg 5 months after dual therapy initiation
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BMC Pediatrics

ISSN: 1471-2431

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