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    • This website is for UK Healthcare Professionals only

      DEMONSTRATED SAFETY PROFILE UP TO 16 WEEKS - RESULTS FROM MEASURE UP 1 AND 22

      The safety profile for RINVOQ 15 mg in adolescents was similar to that in adults.**1

       

      Table adapted from Guttman-Yassky, et al.2

      Approximately 75% of the acne cases were mild, some were moderate, and one severe event was reported.
      *A case of squamous cell cancer.
      Includes one case of squamous cell cancer and one case of basal cell cancer.
      Includes one case of breast cancer and one case of gastric cancer.
      §A case of anal cancer. 
      **The safety and efficacy of the 30 mg dose in adolescents are still being investigated.

      AD, atopic dermatitis; AE, adverse event; CNS, central nervous system; CPK, creatinine phosphokinase; GI, gastrointestinal; HZ, herpes zoster; MACE, major adverse cardiac event; NMSC, non-melanoma skin cancer; OD, once daily; TB, tuberculosis; TEAE, treatment emergent adverse event; VTE, venous thromboembolism.

      ACNE2
      - Of the 162 patients who had treatment-emergent acne, 111/162 patients (68%) had mild acne with most events involving the face. One acne event was severe (>30% of body surface area); all events were non-serious.
      - In Measure Up 1, one patient in the RINVOQ 15 mg group and one patient in the RINVOQ 30 mg group discontinued study drug because of moderate acne; in Measure Up 2, no patients discontinued study drug because of acne.
      - In Measure Up 1, five (24%) of 21 patients in the RINVOQ 15 mg group, 19 (36%) of 53 patients in the RINVOQ 30 mg group, and two (29%) of seven patients in the placebo group who reported a TEAE of acne had a medical history of acne.
      - In Measure Up 2, 15 (43%) of 35 patients in the RINVOQ 15 mg group, 16 (37%) of 43 patients in the RINVOQ 30 mg group, and four (67%) of six patients in the placebo group who reported a TEAE of acne had a medical history of acne.

      CPK ELEVATION2
      - Most reports of elevations in creatine phosphokinase levels were asymptomatic and associated with exercise; only one case of elevated creatinine phosphokinase levels was reported in the upadacitinib 15 mg group, which led to treatment discontinuation.

      HERPES ZOSTER2
      - The incidence of herpes zoster infection was similar in the upadacitinib 15 mg and upadacitinib 30 mg groups, both of which were higher than the incidence of herpes zoster in the group of patients taking placebo (20 [1·8%] of 1124 patients vs two [<1%] of 559 patients). No cases of herpes zoster led to discontinuation of study drug.

      ECZEMA HERPETICUM2
      - All opportunistic infections reported were cases of eczema herpeticum (three patients in the upadacitinib 15 mg groups, three patients in the upadacitinib 30 mg groups, and four patients in the placebo groups).
      - Most cases were mild or moderate, with the exception of one severe case in a patient in the upadacitinib 15 mg group in Measure Up 1. 
      - All cases resolved and none led to treatment discontinuation.


      MALIGNANCIES2
      - Six cases of malignancy were reported (all occurring in patients aged ≥50 years) in the upadacitinib groups (squamous cell skin carcinoma [n=2], basal cell skin carcinoma [n=1], breast cancer [n=1], gastric cancer [n=1],and anal cancer [n=1]). 
      - None of the malignancies were considered to be related to the study drug. 
      - Both cases of squamous cell skin carcinoma were reported in patients with known risk factors and who also had a history of squamous cell skin cancer.

      DEMONSTRATED SAFETY PROFILE IN ADULTS UP TO 16 WEEKS - RESULTS FROM HEADS UP STUDY3

      Table to show TEAEs through week 16 for all patients receiving 1 dose or more of study drug

      Table adapted from Blauvelt A, et al.3

      aAs assessed by investigator.
      bA 40-year-old woman who had bronchopneumonia associated with influenza A was found deceased at home on study day 70.
      cAll opportunistic infections were eczema herpeticum.
      dKeratoacanthoma, no reasonable possibility of association with study drug according to the investigator.
      eInvasive ductal breast carcinoma, reasonable possibility of association with study drug according to the investigator.
      fHepatic disorders: most were elevated transaminase levels.
      gMost acne events consisted primarily of inflammatory papules, pustules, and comedones, involving the face. All events were nonserious. None led to treatment discontinuation.

      AE, adverse event;  CPK, creatinine phosphokinase; NMSC, non-melanoma skin cancer; SAE, serious AE; TB, tuberculosis; TEAE, treatment emergent adverse event

      ACNE AND CONJUNCTIVITIS
      - All acne events were mild or moderate in severity, primarily involved the face and trunk, and did not result in scarring; none led to study drug discontinuation.3
      - All conjunctivitis cases were mild or moderate in severity, and none led to study drug discontinuation.3

      AEs OF SPECIAL INTEREST
      - Rates of serious infection (4[1.1%] vs 2 [0.6%]), eczema herpeticum (1 [0.3%]vs 0%), and herpes zoster (7 [2.0%] vs 3 [0.9%]) were numerically higher for patients treated with upadacitinib than those treated with dupilumab, all at generally low levels. Each of the serious infections was reported in a single patient. No eczema herpeticum or herpes zoster event was considered to be serious and all herpes zoster events were mild or moderate in severity, and none led to study drug discontinuation.3
      - Rates of hepatic disorders was higher among patients treated with upadacitinib than those treated with dupilumab (10 [2.9%] vs 4 [1.2%]). Most were transaminase elevations that were mild or moderate in severity, transient, and reported as singular abnormalities without recurrence; none were serious, and 2 upadacitinib treated patients discontinued study drug owing to transaminase elevation.3
      - Rates of anemia (7 [2.0%] vs 1 [0.3%]), neutropenia (6 [1.7%] vs 2 [0.6%]), and creatinine phosphokinase elevations (23 [6.6%] vs 10 [2.9%]) were higher for patients treated with upadacitinib than those treated with dupilumab, respectively. There was a single event of thrombocytopenia (grade 1 in severity) reported in a patient treated with upadacitinib. Most of these laboratory test–related AEs were mild or moderate in severity, transient, and reported as singular abnormalities without recurrence, with only 1 event deemed serious (decreased hemoglobin reported in the dupilumab-treated group); none of these events led to study drug discontinuation. No drug-induced liver injury or rhabdomyolysis events were reported.3

      DEMONSTRATED SAFETY PROFILE IN ADULTS UP TO 24 WEEKS - RESULTS FROM HEADS UP STUDY4

      Table to show TEAEs through to week 24 for all patients receiving 1 dose or more of study drug

      Table adapted from Blauvelt, et al.4

      aAs assessed by investigator;

      b40 y/o woman found deceased at home on study Day 70 who had bronchopneumonia associated with influenza A

      cAll opportunistic infections were eczema herpeticum

      dkeratoacanthoma;

      einvasive ductal breast carcinoma

      fMost acne events consisted primarily of inflammatory papules, pustules and comedones, involving the face. All events were non-serious. None led to treatment discontinuation.

      TEAE, Treatment-emergent adverse events; AE, Adverse events; SAE, Serious adverse events; NMSC, Non-melanoma skin cancer; CPK, creatinine phosphokinase

      - No new important risks were observed compared to the known safety profile of upadacitinib4

      - Rates of serious infection, eczema herpeticum, herpes zoster, and laboratory-related AEs were higher for upadacitinib4

      - Each of the serious infections was reported in a single patient; no eczema herpeticum or herpes zoster event was serious; most herpes zoster events involved a single dermatome4

      - Most hepatic disorders were asymptomatic transaminase elevations; mild or moderate in severity; none were serious4

      - Rates of anemia, neutropenia, and CPK elevation were higher among upadacitinib-treated patients; no events were serious or led to study drug discontinuation4

      - No cases of adjudicated venous thromboembolic events or major adverse cardiovascular events, active tuberculosis, or gastrointestinal perforation were reported in either treatment group4

      - Most frequently reported AE with upadacitinib was acne; all acne events were mild or moderate in severity, and primarily involved the face and trunk4

      - Conjunctivitis was the most commonly-reported AE for dupilumab4

      - No acne or conjunctivitis events were serious or led to study drug discontinuation4

      The safety profile of RINVOQ with long term treatment was generally similar to the safety profile during the placebo controlled period across indications1

      AD, atopic dermatitis; AS, ankylosing spondylitis; PsA, psoriatic arthritis; RA, rheumatoid arthritis.

       

      Important safety information for RINVOQ1

      You are also strongly advised to read the prescribing information (PI), which can be found using the link at the top of the page.

      Before starting RINVOQ treatment, please note the following:

      1.  RINVOQ should be initiated and supervised by physicians experienced in the treatment of atopic dermatitis.

      2. Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) <0.5 x 109 cells/L, absolute neutrophil count (ANC) < 1 x 109 cells/L or Hb <8 g/dL.

      Concomitant use with other potent immunosuppressants

      • Not recommended, as a risk of additive immunosuppression cannot be excluded

      Infections

      • Do not use RINVOQ in active, serious and localised infections
      • Consider the risks and benefits in patients with chronic/recurrent infection, those exposed to TB, those that have a history of opportunistic/serious infections, those that have resided or travelled in areas of endemic TB/mycoses or with underlying conditions that predispose them to infection
      • Monitor for signs and symptoms of infection during and after treatment. Interrupt treatment if the patient shows signs and symptoms of serious or opportunistic infection. Resume treatment after control of serious infection with careful benefit-risk consideration. Patients who develop new infection require prompt diagnostic testing as appropriate for immunosuppressed patients and appropriate therapy. Monitor closely and interrupt treatment if the patient is not responding to appropriate antimicrobial therapy. Restart RINVOQ when infection controlled
      • There is a higher incidence of infections in the elderly ≥65 years of age, caution should be used when treating this population, doses higher than 15 mg once daily are not recommended in patients aged 65 years and older.

      Tuberculosis

      • Screen pre-treatment for TB. Do not start treatment in patients with active TB. Consult with  a physician experienced in the treatment of TB and consider anti-TB therapy  in those patients with previously untreated latent TB or patients with risk factors for TB infection
      • Monitor for the development of signs and symptoms of TB, including those patients that tested negative for latent TB prior to treatment

      Viral reactivation

      • Consider interrupting treatment if patient develops herpes zoster until resolution
      • Screen pre-treatment for viral hepatitis and monitor for reactivation during therapy. If hepatitis B DNA is detected during treatment consult a liver specialist

      Vaccination

      • It is not recommended to administer live attenuated vaccines during, or immediately prior to RINVOQ treatment
      • It is recommended that patients are brought up-to-date with all immunisations including prophylactic zoster vaccination in agreement with current immunisation guidelines prior to starting RINVOQ

      Malignancy

      • Immunological medicinal products may increase the risk of malignancies in RA patients, consider the risk benefit prior to initiating RINVOQ

      Haematologic abnormalities

      • Screen pre-treatment for abnormalities
      • Do not initiate RINVOQ and consider temporarily interrupting treatment if ANC <1 x 109 cells/L, ALC < 0.5 x 109 cells/L or Hb <8g/dL

      Lipids

      • Monitor lipid levels at 12 weeks and thereafter according to clinical guidelines for hyperlipidaemia

      Hepatic transaminase elevations

      • Contraindicated in severe hepatic impairment
      • Screen LFTs pre-treatment and monitor throughout therapy. Promptly investigate elevated LFTs to rule out drug induced liver injury. If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ therapy should be interrupted until this diagnosis is excluded

      Severe Renal impairment

      • 15mg use with caution

      30mg not recommended

      VTE

      • Use with caution in patient at high risk of DVT/PE and discontinue treatment if clinical signs of DVT/PE occur and treat promptly

      Diverticulitis

      • Diverticulitis may cause gastrointestinal perforation.
      • Use with caution in patients with diverticular disease especially when treated with concomitant medications associated with an increase risk of diverticulitis: NSAIDs, corticosteroids and opioids.
      • Promptly evaluate new onset abdominal signs and symptoms for early identification.

      Cardiovascular

      • Manage patients with known cardiovascular risk factors e.g. hypertension, hyperlipidaemia as part of usual standard of care

      Allergic reaction

      • Contraindicated in patients with known hypersensitivity to active substance or to any of its excipients

      Pregnancy and lactation

      • Contraindicated in pregnancy
      • Women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of RINVOQ
      • Should not be used during breastfeeding

      Food and drink

      • Should not consume food or drink containing grapefruit juice during treatment

      Adolescents

      • AD patients 12-17 years should weigh at least 30kg 

      Adverse reactions

      Very common adverse reactions (≥1/10): Upper respiratory tract infections and acne. Common adverse reactions (≥1/100 to <1/10): Bronchitis, herpes zoster, herpes simplex, folliculitis, influenza, anaemia, neutropenia, hypercholesterolaemia, cough, abdominal pain, nausea, urticaria, fatigue, pyrexia, increased blood CPK/ALT/AST, increased weight and headache. Serious adverse reactions:  The most common serious adverse events were serious infections. 

      I want to find out more about RINVOQ

      1. RINVOQ Summary of Product Characteristics. 2021. 
      2. Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021;397(10290):2151–2168.
      3. Blauvelt A, Teixeira H, Simpson E, et al. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis. A Randomized Clinical Trial. JAMA Dermatol. 2021; Published online August 4, 2021. DOI:10.1001/jamadermatol.2021.3023
      4. Blauvelt A, Teixeira H, Simpson E, et al. Upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: analysis of the Heads Up Phase 3 trial. Presentation for the 11th Georg Rajka International Symposium on Atopic Dermatitis (ISAD 2021, Hybrid Meeting), April 19–20, 2021
      5. Reich K, Teixeira HD, Bruin-Weller M, et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021;397(10290):2169–2181. 
      6. European Medicines Agency. RINVOQ EPAR: Public Assessment Report. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rinvoq. Accessed August 2021.
      7. Rubbert-Roth A, Enejosa J, Pangan AL, et al. Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. N Engl J Med. 2020;383(16):1511–1521.
      8. Kameda H, Takeuchi T, Yamaoka K, et al. Efficacy and safety of upadacitinib in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE): a placebo controlled phase IIb/III study. Rheumatology (Oxford). 2020;59(11):3303–3313.
      9. Xiaofeng Zeng, Dongbao Zhao, Sebastiao Radominski, Efficacy and Safety of Upadacitinib in Patients From China, Brazil, and South Korea With Rheumatoid Arthritis Who Have Had Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs. Abstract presented at the European Congress of Rheumatology, 3–6 June 2020. Abstract SAT0160.
      10. ClinicalTrials.gov A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (Rising Up). Available at: https://clinicaltrials.gov/ct2/show/NCT03661138. Accessed August 2021.

      UK-RNQD-210308. Date of preparation: March 2022

      Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
      Adverse events should also be reported to AbbVie on GBPV@abbvie.com