Upadacitinib (Rinvoq) for ulcerative colitis

What is upadacitinib (Rinvoq)?

Rinvoq is the brand name for upadacitinib. It’s a type of drug called a JAK (Janus-associated tyrosine kinase) inhibitor used in the treatment of adults with moderately or severely active ulcerative colitis. It is currently licensed for use in the USA by the Food and Drug Administration (FDA) and has approval for NHS use in Scotland (approved by Scottish Medicines Consortium SMC) and in the UK by the National Institute of Health and Care Excellence (NICE).

How does upadacitinib work?

JAKs are proteins that are involved in activating your immune response, which can cause inflammation in the gut in ulcerative colitis patients. Upadacitinib works to block the effects of JAKs and reduce inflammation. It can help to reduce the symptoms of ulcerative colitis and reduce your need for steroids. It aims to reduce inflammation in the gut, prevent flares and improve symptoms, including bloody stools, abdominal pain, urgency and frequency of bowel movements.

Who can take upadacitinib?

Upadacitinib is recommended as a treatment option for adults with moderately or severely active ulcerative colitis when other inflammatory bowel disease (IBD) treatments, i.e., TNF blockers have been tried but prove unsuccessful.

• Responding unsuccessfully means: 
• If your ulcerative colitis did not respond adequately to biologic treatments like infliximab, adalimumab and golimumab
• You have not got better or have stopped getting better while on them
• You can’t tolerate biologic treatments

Before starting upadacitinib you should tell your doctor if you believe you may currently have any infections. Upadacitinib can reduce your body’s ability to fight infections. It may make an existing infection worse or increase the chance of you getting a new infection. 

Signs of infection may include fever, sweating, chills, muscle aches, cough, shortness of breath, new phlegm or change in phlegm, weight loss, warm or red or painful skin or sores on your body, difficulty or pain when swallowing, diarrhoea or stomach pain, burning when you urinate or urinating more often than normal, feeling very tired. 

You will need blood tests before you start taking upadacitinib, or while you are taking it to check for low red blood cell count (anaemia), low white blood cell count (neutropenia or lymphopenia), high blood fat (cholesterol) or high levels of liver enzymes. The tests are to check that treatment with upadacitinib is not causing problems.

Other considerations are:

• If you have ever had a chronic infection (such as tuberculosis (TB), shingles, HIV, or hepatitis). Your doctor may test you for TB before starting treatment with upadacitinib and monitor you for signs and symptoms of TB during treatment with upadacitinib
• If you have cancer or if you have previously had cancer. Upadacitinib may increase your risk of certain cancers, including lymphoma and skin cancer. Current or past smokers are at higher risk for lymphoma and lung cancer
• If you have heart problems, there is an increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years and older with at least one heart disease risk factor, especially in current or past smokers
• If you have blood clots in the veins of the legs or lungs and arteries. The risk is higher for people aged 50 years and older with at least one heart disease risk factor
• Tears in the stomach or intestines is a side effect - for patients with a history of diverticulitis the risk of this happening is increased when taking upadacitinib
• If you are pregnant - upadacitinib can’t be taken in pregnancy because of the risk of damage to the developing baby
• Breastfeeding - because of the potential for serious adverse reactions in the breastfed baby, breastfeeding is not recommended during taking upadacitinib and for a period of time after finishing the therapy
• If you recently had a vaccine or are due to have one. You should wait a certain amount of time before starting upadacitinib, which your doctor can advise you about 

You should also tell your doctor if you take any other medications, over-the-counter medicines or vitamins or supplements. It’s also worth noting that food or drink containing grapefruit should be avoided during treatment with upadacitinib as it may increase the risk of side effects by increasing the amount of upadacitinib in your body.

How do you take upadacitinib?

Upadacitinib is in tablet form, usually taken orally once a day, with or without food. You may start with a higher dose for around eight weeks (induction dose) before reducing to a lower daily dose (maintenance dose).

What are the side effects and risks of upadacitinib? 

The most common reported side effects of upadacitinib are (also see ‘Who can take upadacitinib?’):

Very common (may affect more than 1 in 10 people):

• Throat and nose infections
• Acne

Common (may affect up to 1 in 10 people):

• Cough
• Fever
• Cold sores (herpes simplex)
• Nausea
• Increase in an enzyme called creatine kinase, shown by blood tests
• Low white blood cell counts shown in blood tests
• Increased levels of cholesterol (a type of fat in the blood) as shown in tests
• Increased levels of liver enzymes, shown by blood tests (sign of liver problems)
• Weight gain
• Inflammation (swelling) of the hair follicles
• Flu
• Anaemia
• Stomach pain
• Fatigue
• Headache
• Hives (urticaria)
• Urinary tract infection
• Rash

Uncommon (may affect up to 1 in 100 people):

• Thrush in the mouth
• Increased levels of triglycerides (a type of fat) in the blood, as shown in tests
• Diverticulitis (painful inflammation of small pockets in the lining of your intestine)

Can I take upadacitinib with other medication?

Upadacitinib may interact with some other medications so it’s important you tell your doctor about any medications you are taking before starting, including over-the-counter medicines and supplements. 

Other medicines that may also affect how upadacitinib works are medicines used to treat fungal or bacterial infections, rifampicin or phenytoin and medicines that affect your immune system. Plus, medicines to treat seizures or fits, such as phenytoin.

Upadacitinib is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis, or with other immunosuppressants such as azathioprine and cyclosporine.

It’s really important you tell your doctor as there may be other drug interactions not mentioned here. ^¹

More information: 

Rinvoq was developed by the biotech company AbbVie and has received approval for use in treating ulcerative colitis in the USA by the Food and Drug Administration (FDA) and has also received approval from the European Commission and the Scottish Medicines Consortium (SMC) for use by the NHS in Scotland and in the UK by the National Institute of Health and Care Excellence (NICE). It is awaiting review by NICE for use in the treatment of Crohn's disease.