From the Guidelines
Xeljanz (tofacitinib) can be used during an acute ulcerative colitis episode while on corticosteroids and antibiotics, but this requires careful medical supervision. The current evidence supports the use of tofacitinib for the induction and maintenance of remission in moderate-severe ulcerative colitis, as stated in the AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis 1.
Key Considerations
- Typically, Xeljanz is initiated at 10 mg twice daily for 8-16 weeks for acute severe ulcerative colitis, then potentially reduced to 5 mg twice daily for maintenance.
- When starting Xeljanz while on corticosteroids, the goal is usually to taper off steroids gradually as Xeljanz takes effect, which may occur over 4-8 weeks depending on clinical response.
- Concurrent antibiotic use is generally acceptable, though certain antibiotics like rifampin may reduce Xeljanz effectiveness.
- Important considerations include increased infection risk with this combination therapy, particularly for opportunistic infections.
Precautions and Monitoring
- Before starting, patients should undergo tuberculosis screening, hepatitis testing, and have complete blood counts and liver function tests monitored regularly 1.
- Vaccination status should be updated before beginning therapy when possible.
- This combination approach aims to control inflammation through multiple mechanisms - Xeljanz by inhibiting Janus kinase signaling pathways, corticosteroids through broad anti-inflammatory effects, and antibiotics by addressing any infectious triggers or complications.
Guideline Recommendations
- The AGA suggests using biologic monotherapy (TNF-α antagonists, vedolizumab or ustekinumab) or tofacitinib rather than thiopurine monotherapy for induction of remission in adult outpatients with active moderate-severe ulcerative colitis 1.
- The guidelines also recommend early use of biologic agents with or without immunomodulator therapy, rather than gradual step up after failure of 5-aminosalicylates, in adult outpatients with moderate-severe ulcerative colitis 1.
From the Research
Use of Xeljanz during an Acute Ulcerative Colitis Episode
- Xeljanz (tofacitinib) can be used as a rescue therapy in biologic-experienced patients with acute severe ulcerative colitis, as shown in a case series where all four patients experienced improvement in objective symptoms and laboratory markers 2.
- Tofacitinib may be an acceptable rescue agent in biologic-experienced patients with acute severe ulcerative colitis and can be safely continued as maintenance therapy once remission has been achieved 2.
- A case series reported successful initial tofacitinib treatment for acute severe ulcerative colitis with steroid resistance, with six out of eight patients able to avoid colectomy 3.
Combination Therapy with Corticosteroids and Antibiotics
- A randomized controlled trial investigated the addition of tofacitinib to corticosteroids in patients with acute severe ulcerative colitis and found that the combination improved treatment responsiveness and decreased the need for rescue therapy 4.
- The trial showed that 83.01% of patients receiving tofacitinib achieved response to treatment by day 7, compared to 58.82% of patients receiving placebo 4.
- Another study reported the success of cyclosporin and tofacitinib combination therapy in a patient with severe steroid-refractory ulcerative colitis 5.
Safety and Adverse Events
- The studies reported few adverse events, with one patient experiencing local herpes zoster treated with acyclovir without tofacitinib discontinuation 3.
- Another study reported a case of acute appendicitis as a visceral side effect of tofacitinib therapy in a patient with ulcerative colitis, highlighting the need for careful monitoring of patients on immunosuppressive therapy 6.
- The randomized controlled trial found that most treatment-related adverse effects were mild, with one patient developing dural venous sinus thrombosis 4.