RINVOQ (upadacitinib) is indicated for the treatment of adults and adolescents 12 years and older with moderate to severe atopic dermatitis who are candidates for systemic therapy (1)
• Robust EASI 75 & 90 skin clearance rates at Week 16, sustained through Week 521-3
• Rapid skin clearance with EASI 75 as early as Week 21,2
• Significant itch reduction rates (NRS ≥4)* at Week 16, sustained through Week 521-3
• Rapid itch reduction (NRS ≥4)* 1 day after treatment initiation with RINVOQ 30 mg**‡1,2
• Superiority to dupilumab in EASI 75/90/100 skin clearance rates at Week 16 with RINVOQ 30 mg†4
• Superiority to dupilumab in itch reduction‡ as early as Week 1, sustained at Week 16 with RINVOQ 30 mg†4
• Well-studied safety profile in >10,500 patients*, across 2 indications and 16 Phase 3 trials2,4–10
• Similar safety profile with RINVOQ 15 mg across adults and adolescents in AD§1
* 10,500 patients includes all patients across all arms (active treatment and placebo) in the following Phase 3 trials in RA: (SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-BEYOND, SELECT-CHOICE, SELECT-SUNRISE, SELECT-CHINA), and AD (RISING UP, MEASURE UP 1, MEASURE UP 2, AD UP, HEADS UP). Of the total number of patients included in these trials, 6,280 were randomized to receive RINVOQ at either dose. This includes 343 adolescent patients (aged 12 to 17 years) in the Phase 3 MEASURE UP 1, MEASURE UP 2 and, AD UP studies in atopic dermatitis.
*With a ≥4-point improvement in Worst Pruritus NRS from baseline.
**With 30 mg dose only; 2 days after initiation with 15 mg dose.
†RINVOQ 30 mg QD vs dupilumab 300 mg Q2W.
‡Mean percent change in Worst Pruritus NRS from baseline.
§RINVOQ 30 mg is still being investigated for adolescents. Only RINVOQ 15 mg is currently approved for use in adolescents.1
AD: Atopic Dermatitis; EASI: Eczema Area and Severity Index; EASI 75/90: ≥75/90% reduction in EASI; JAK: janus kinase; NRS: numerical rating scale; Q2W: once every two weeks; QD: once daily; TCS: topical corticosteroids.
RINVOQ preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. Atopic dermatitis (AD) is driven by pro-inflammatory cytokines that transduce signals via the JAK1 pathway. Inhibiting JAK1 with RINVOQ reduces the signaling of many mediators which drive the signs and symptoms of AD.1
Rheumatoid arthritis
RINVOQ (upadacitinib) is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDS.
Atopic Dermatitis
RINVOQ is indicated for the treatment of adults and adolescents 12 years and older with moderate to severe atopic dermatitis who are candidates for systemic therapy
AD: atopic dermatitis; ; RA: rheumatoid arthritis.
See the RINVOQ Summary of Product Characteristics for full Prescribing Information.
REFERENCES
- RINVOQ Saudi Summary of Product Characteristics – [July , 2021].
- Guttman-Yassky E, Teixeira H, Simpson E, 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; DOI: 10.1016/S0140-6736.
- Simpson EL, Papp KA, Blauvelt A, et al. Efficacy and Safety of Upadacitinib in Patients With Atopic Dermatitis: Results Through Week 52 From Replicate,Phase 3, Randomized, Double-Blind, Placebo-Controlled Studies: Measure Up 1 and Measure Up 2. Presented at the 2021 Dermatology EducationFoundation (DEF) Essential Resource Meeting (DERM2021), August 5–8, 2021, Las Vegas NV, USA.
- Blauvelt, A, et al. Upadacitinib Versus Dupilumab in Adults with Moderate-to-Severe Atopic Dermatitis: Analysis of the Heads Up Phase 3 Trial. International Society of Atopic Dermatitis (ISAD) 2021 Annual Meeting: Abstract PT29.
- European Medicines Agency. RINVOQ EPAR: Public Assessment Report. Available at: https://www.ema.europa.eu/en/medicines/human/ EPAR/rinvoq. Accessed April 2021.
- Reich K, Teixeira HD, Bruin-Weller, 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; DOI:10.1016/ S0140-6736(21)00589-4.
- 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.
- 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.
- 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.
- 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 March 2021.
Imprtant Safety Information:
SERIOUS INFECTIONS
Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death
Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
If a serious infection develops, interrupt RINVOQ until the infection is controlled.
Reported infections include:
•Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ use and during therapy. Treatment for latent infection should be considered prior to RINVOQ use.
•Invasive fungal infections, including cryptococcosis and pneumocystosis.
•Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
The risks and benefits of treatment with RINVOQ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy
Warnings and Precautions .
MALIGNANCIES
Lymphoma and other malignancies have been observed in patients treated with RINVOQ [see Warnings and Precautions .
THROMBOSIS
Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
For Adverse Events Reporting:
Email: [email protected]
Hotline number: +966 55 828 2010
SA-UPAD-210005 - Oct 2021