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Xeljanz For Ulcerative Colitis Reviews

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Can I Take Xeljanz With A Biologic

No, you shouldnt take Xeljanz or Xeljanz XR with a biologic drug. Biologic drugs are made in a lab from living cells. Many biologics are designed to suppress the ability of your immune system to fight infections. This is because biologics are generally used to treat autoimmune disorders, which are caused by your immune system mistakenly attacking your own body.

Taking Xeljanz or Xeljanz XR with biologics can suppress your immune system too much. This can increase your risk of very serious infections that your body wont be able to fight off.

Talk with your doctor to learn more about which medications are safe to use with Xeljanz or Xeljanz XR.

Xeljanz And Other Medications

Below are lists of medications that can interact with Xeljanz and Xeljanz XR. These lists do not contain all the drugs that may interact with the medications.

Before taking Xeljanz or Xeljanz XR, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Xeljanz and certain antibiotics and antifungals

Taking Xeljanz or Xeljanz XR with certain antibiotics and antifungals can increase your risk of serious side effects. Certain antibiotics and antifungals can prevent your body from breaking down Xeljanz and Xeljanz XR. This leads to high levels of Xeljanz or Xeljanz XR in your body, which can increase side effects from the drug.

Examples of antibiotics that can increase your risk of serious side effects if taken with Xeljanz or Xeljanz XR include:

Examples of antifungals that can increase your risk of serious side effects if taken with Xeljanz or Xeljanz XR include:

If you need to take one of these antibiotics or antifungals while youre taking Xeljanz or Xeljanz XR, your doctor will monitor you closely for side effects. Your doctor will also likely recommend that you take a lower dosage of Xeljanz or Xeljanz XR until youre no longer taking the antibiotic or antifungal.

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Key Points About Remicade

  • Remicade is given by IV.
  • Remicade is approved for Crohns disease and ulcerative colitis.
  • Three starting doses are given .
  • After the starting doses, its given about every eight weeks .
  • Common side effects are abdominal pain, nausea, fatigue, and vomiting.
  • If you are pregnant or plan to become pregnant, you and your doctor should decide if you should take Remicade.

Post Guideline Publication Recommendations Regarding Thromboembolic Risk And Lipids

FDA to Add New Warnings to Popular JAK Inhibitor Xeljanz

In May 2019, following the publication of the NICE recommendations,1 the US Food and Drug Administration 9 and then the European Medicine Agency10 expressed concerns over the results of an ongoing study in RA patients which showed an increase risk of venous thromboembolism and death when the higher dose of 10mg bd was used. After this, the Medicines and Healthcare products Regulatory Agency in March 2020 recommended11 the following:

  • For any dose and in any indication, exercise caution when considering tofacitinib in patients who have known risk factors for venous thromboembolism, in addition to their underlying disease.
  • Maintenance treatment for UC at the 10mg bd dose is not recommended in patients with known risk factors for venous thromboembolism, unless there is no suitable alternative treatment.

Listed risk factors for venous thromboembolism include:

  • Previous venous thromboembolism.

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Comparative Efficacy Of Tofacitinib Vs Biological Therapies

In the absence of headtohead trials, evidence of the comparative efficacy of tofacitinib and biological therapies is based on indirect evidence from four network meta-analyses . These all compared tofacitinib with antiTNF and anti-integrins , and all synthesized data from randomized controlled phase II and/or III trials. Three out of four NMAs used clinical and endoscopic efficacy endpoints as outcomes,5456 whereas one used HRQoL.57

Singh and Bonovas undertook their analyses of clinical and endoscopic endpoints in anti-TNF naïve cohorts by basing their probabilities of each treatment being superior. The authors concluded that infliximab and VDZ may be superior for the induction of clinical response, remission, and MH.58,59 Trigo-Vicente et al reached similar conclusions.56 However, the addition of ozanimod and etrolizumab in their analysis showed that ozanimod may be better than infliximab for the achievement of MH. In contrast, for patients who were anti-TNF experienced, tofacitinib was ranked higher for the induction of remission and of MH compared to the other available treatments.58 For the maintenance of remission, no indirect comparisons were performed for anti-TNF experienced patients.5456 However, in anti-TNF naïve patients, Trigo-Valente et al found that tofacitinib had the highest probability of being the best treatment in the maintenance of remission, sustained remission and for MH.

Safety Of Tofacitinib In Uc

The first centralized evaluation of the short- and long-term safety profile of tofacitinib in the management UC was recently published.58 The report was focused on specific adverse events , including herpes zoster , opportunistic infections , malignancies, non-melanoma skin cancers , major adverse cardiovascular events , and gastrointestinal perforations. The safety data were collated from the four aforementioned market-authorizing trials, including 1157 patients over a 4.4-year period . They were analyzed as 3 cohorts: the induction cohort, which included data from patients randomized to placebo or tofacitinib from the dose-finding phase II and the two phase III induction trials the maintenance cohort, that included data from patients from the Sustain trial and the laboratory cohort that included data from patients from the induction and the sustain cohort who were evaluated for changes over time in laboratory parameters. Serious adverse events were defined as any events threatening life, resulting in death, causing persistent or significant disability or incapacity, requiring or prolonging hospitalization, or causing congenital anomaly or birth defect.

No clinically meaningful changes were observed in various laboratory parameters, including the low-density lipoprotein/high-density lipoprotein ratio, hemoglobin, absolute lymphocyte count, and creatine kinase.61

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Tofacitinib In Special Circumstances

Use in acute severe UC

The rapid onset of action and short half-life have raised the prospect of using tofacitinib in the management of acute severe UC . Data remain limited to a few case reports.30,6064 In three case series, 14 of 15 patients received 3 days high-dose intravenous steroids prior to rescue tofacitinib with a history of anti-TNF failure.30 Eleven patients received standard induction dosing 10 mg BD, whereas the Michigan group used a higher dose of 10 mg three times daily.30,60 Following tofacitinib rescue therapy, 13% required colectomy during that index admission and 20% within 6 months, with no difference in colectomy rates according to tofacitinib dose.30 At the last follow-up, 47% remained in CFCR on maintenance therapy.30 Kotwani et al. reported endoscopic remission in addition to CFCR at last follow-up in 2 of the 4 patients included in their small case series.63 Overall, no major AEs were reported and notably no new thromboembolic events.30,61,64

More recently, a retrospective casecontrol study evaluated the efficacy of tofacitinib induction therapy in hospitalized patients with biologic-experienced ASUC.65 Compared to matched controls, there was a lower 90-day colectomy rate in the 40 patients who received tofacitinib with intravenous corticosteroids . The benefit was only statistically significant at tofacitinib 10 mg three times daily and not at 10 mg BD dosing.65

Post-operative surgical outcomes

Can Loss Of Clinical Response With Tofacitinib Be Recaptured With Dose Increase

Xeljanz vs Rinvoq: Same Drug Class But Is One Really Better Than The Other?

2.3.1 What is known from observations in the UC clinical programme?

Dose increase to recapture response was explored in the OCTAVE Open study amongst patients with maintenance treatment failure . A post hoc analysis evaluated a group of patients who had a clinical response to tofacitinib 10 mg b.d. induction therapy, subsequently experienced treatment failure after being re-randomised to receive tofacitinib 5 mg b.d. maintenance therapy and then had their dose increased to tofacitinib 10 mg b.d. in OCTAVE Open. Following dose increase, 57.9% and 64.9% of patients recaptured clinical response at Months 2 and 12, respectively.

Patients who had their dose increased following a flare during OCTAVE Open were also assessed . Flare was defined as an increase in total Mayo score of â¥3 points from a baseline of OCTAVE Sustain, accompanied by an increase in rectal bleeding and endoscopic subscores of â¥1 point, after a minimum of 8âweeks of treatment. Amongst the maintenance remission subpopulation , the tofacitinib dose was increased from 5 to 10 mg b.d. due to flare in 25.2% of patients. Following dose increase, 73.2% , 58.5% , 64.1% and 48.7% of patients achieved partial Mayo score remission at Months 3, 6, 9 and 12, respectively .

2.3.2 Real-world and registry database observations

2.3.3 Interpretation and conclusions

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Side Effects And Special Concerns

According to Xeljanz prescribing information, care should be taken when prescribing this medication to anyone who:

  • Currently has a serious infection
  • Is at risk for perforation of the intestines
  • Has a low count of neutrophils or lymphocytes, both types of white blood cells
  • Has a low hemoglobin level

From the results of clinical trials in ulcerative colitis patients receiving 10 mg of Xeljanz twice a day, the most common side effects and the percentage of patients in which they occurred included:

  • High blood pressure

Can Xeljanz Be Crushed Split Or Chewed

You may be able to crush, split, or chew Xeljanz tablets. If you have trouble swallowing the tablets, talk with your doctor or pharmacist. They can recommend ways to make swallowing the medication easier for you.

However, you shouldnt crush, split, or chew Xeljanz XR tablets. These should be swallowed whole. If you have trouble swallowing Xeljanz XR tablets, talk with your healthcare professional. They can recommend ways to help you swallow the tablets, or they may prescribe a different form of Xeljanz for you.

Xeljanz and Xeljanz XR are used to decrease pain and inflammation in people with certain autoimmune disorders.

Theyre used in certain adults with:

Xeljanz is also used for certain children ages 2 years and older who have polyarticular juvenile idiopathic arthritis .

To learn about these conditions, see the Xeljanz uses section above.

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The Science From Spain

In another study presented at ECCO 22 Virtual, investigators from Spain compared vedolizumab to ustekinumab after at least one anti-TNF treatment failure, this time among people with Crohns disease.

Finding effective treatments after an anti-TNF failure is essential, Maria Jose Garcia, MD, said when presenting the results of the VERSUS-CD trial. Over 20% to 30% of Crohns disease patients are nonresponders or develop intolerance to anti-TNF therapies. Also, anti-TNF responders can experience a loss of response over time.

Both vedolizumab and ustekinumab are effective for Crohns, she said. But no clinical trial has compared both treatments, and limited data exist in real life.

To remedy this situation, Garcia and colleagues studied 755 people from 30 medical centers in a national database in Spain who failed a previous anti-TNF agent, including 195 people switched to vedolizumab and 560 switched to ustekinumab. Luminal activity, perianal disease, or postoperative recurrence of Crohns were the indications for treatment.

The studys main objective was to compare the short- and long-term treatment survival rate of vedolizumab and ustekinumab after anti-TNF therapy failure in clinical practice. Evaluating efficacy and safety were secondary aims.

Just less than half of the 327 patients discontinued treatment over time, including 142 in the vedolizumab group and 185 in the ustekinumab group. The most frequent cause was primarily non-response.

What To Do In Case Of Overdose

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If you think youve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Xeljanz or Xeljanz XR from the pharmacy, the pharmacist will add an expiration date to the label on the medication. This date is typically 1 year from the date they dispensed it.

The expiration date helps guarantee the effectiveness of the medication during this time. The of the Food and Drug Administration is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Note that Xeljanz oral solution expires 60 days after you open the bottle.

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What Is The Expectation For Patients After Temporary Treatment Interruption And Subsequent Retreatment

Interruption of UC treatment may be necessary for a variety of reasons, including illness, pregnancy, adverse events, comorbidities, infection, surgery, or funding. It is, therefore, important for physicians managing patients with UC to understand the possible clinical consequences of temporarily discontinuing a therapy, such as relapse rates and time to relapse.

The potential to recapture response following retreatment with UC therapy is an important consideration when interrupting treatment. Retreatment with biologics can be challenging due to the risk of neutralising anti-drug antibody formation leading to secondary loss of response. However, as tofacitinib is a small molecule, the risk of it inducing an immunogenic response that might limit retreatment is extremely low.

2.4.1 Temporary treatment interruption: what is known from observations in the UC clinical programme?

In the OCTAVE studies, the effect of treatment interruption was evaluated in 174 patients who had a clinical response at the end of OCTAVE Induction 1 and 2 and were re-randomised to receive a placebo for 52âweeks in OCTAVE Sustain . Following treatment interruption, the proportion of patients with clinical response in the temporary treatment interruption subpopulation declined from 98.9% at OCTAVE Sustain baseline to 19.0% at Week 52 of OCTAVE Sustain.

2.4.2 Recapture of response with retreatment: what is known from observations in the UC clinical programme?

2.4.4 Interpretation and conclusions

Efficacy In Phase Iii Trials

Induction of Remission and Mucosal Healing

The efficacy of tofacitinib in the induction of remission in patients with moderately-to-severely active UC was investigated in two multi-center, double-blind, placebo-controlled phase 3 trials, named OCTAVE Induction 1 and 2.40 In these trials, 1139 eligible patients were randomized to receive tofacitinib 10 mg or placebo twice a day for an 8-week period. The patients had moderately-to-severe active extensive colitis with a median disease duration of 6 years, mean age of 41years, with 59% of the participants being male and 80% caucasian. Approximately 70% of the patients had previously failed immunosuppressants other than biologic agents or corticosteroids, 52% had failed treatment with anti-TNF , and 46% were taking oral corticosteroids upon entry. Aminosalicylates or prednisolone up to 25 mg OD was allowed over the treatment period, but no immunomodulators or biologic therapies. The primary endpoint was clinical remission at 8 weeks . The key secondary endpoint was mucosal healing at 8 weeks. Clinical remission at 8 weeks occurred in 19% and 17% of the tofacitinib group, whereas the placebo groups had a remission rate of 8% and 4% in OCTAVE Induction 1 and 2, respectively .

MH was achieved in 31% and 28% in tofacitinib versus 16% and 12% in those receiving placebo .

Maintenance of Remission and Mucosal Healing

Long-Term Efficacy

Flowchart of participants progress through the OCTAVE trials.

Recapturing Response

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How Effective Are Biologics For Ulcerative Colitis

Biologics can help bring ulcerative colitis into remission. Remission occurs when the symptoms of ulcerative colitis are gone.

A 2020 review of research found that Remicade was the most effective biologic for reducing the signs and symptoms of ulcerative colitis in people who had never used biologics before.

The same review found that Stelara was the most effective biologic for treating ulcerative colitis in people who had used anti-TNF agents in the past without satisfying results.

Tofacitinib was also highly effective for treating ulcerative colitis in people who had previously used anti-TNF agents. Xeljanz is a JAK inhibitor, which is not a biologic.

These results reflect average trends. Different medications may affect different individuals in different ways. People may need to try multiple medications to find one that works for them.

The authors of one 2019 review reported that up to 30% of people with ulcerative colitis eventually need surgery to treat it. Some evidence has suggested that using biologics may delay the need for surgery.

What Should I Know About Xeljanz Vs Humira

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You may wonder how Xeljanz and Xeljanz XR compare with Humira.

Both types of Xeljanz contain the active drug tofacitinib, while Humira contains the active drug adalimumab. Humira is given as an injection under the skin. But Xeljanz and Xeljanz XR are taken by mouth. Xeljanz comes as tablets and a liquid solution, and Xeljanz XR comes as tablets.

These medications have some shared uses and some unique ones. Theyre both used in adults with:

Theyre also both used for juvenile idiopathic arthritis in certain children.

Humira is also approved to treat Crohns disease, plaque psoriasis, hidradenitis suppurativa, and uveitis in certain people.

To learn more about how these drugs compare, check out this side-by-side comparison. Also, ask your doctor if either medication is right for your condition.

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