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ANKYLOSING SPONDYLITIS

RINVOQ, the first ever once-daily oral JAK inhibitor for the treatment of active AS, PsA and RA1

 

In AS, RINVOQ provides

Improvement in ASAS40 from as early as Week 2 and maintained to Week 64, with significantly more patients treated with RINVOQ 15mg achieving ASAS40 at Week 14 vs placebo.*

Improvement in ASDAS inactive disease rates vs placebo at Week 14.1-3

Significant improvement in signs of inflammation, as measured by SPARCC-MRI of Spine vs placebo at Week 14. 

Improvements in BASFI as well as patient-reported back pain, peripheral pain and swelling and nocturnal back pain seen at Week 14.1,2

The safety profile of RINVOQ in AS was consistent with previously reported results in Rheumatoid Arthritis and no new significant safety signals were identified.1-5

*Data from SELECT-AXIS 1 in adult bio-naive NSAID-IR patients with active AS. Primary endpoint of SELECT-AXIS 1, ASAS40 response with RINVOQ vs placebo at Week 14, was met (52% vs 26%; p<0.001).

Data from SELECT-AXIS 2 (AS) in adult bDMARD-IR patients with active AS. Primary endpoint of SELECT-AXIS 2 (AS), ASAS40 response with RINVOQ vs placebo at Week 14, was met (45% vs 18%; p<0.0001).3

NICE Publishes Positive Technology Appraisal Guidance (TAG) for RINVOQ for treating active Ankylosing Spondylitis in adults6

RINVOQ is recommended as an option for treating active ankylosing spondylitis that is not controlled well enough with conventional therapy in adults, only if:

  • Tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough
  • AbbVie provides RINVOQ according to the commercial arrangement

RINVOQ is accepted for use within NHS Scotland in adult patients with active Ankylosing Spondylitis7

Indication under review: for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy.

  • in a phase III and a phase II/III study, upadacitinib when compared with placebo, significantly improved symptoms of AS in adults with active disease that was inadequately controlled with non-steroidal anti-inflammatory drugs (NSAIDs). 

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

References

  1. RINVOQ SmPC.
  2. van der Heijde D, et al. Lancet 2019;394:2108-2117.
  3. Deodhar A, et al. Arthritis Rheumatol. 2020;72(suppl. 10):2023.
  4. McInnes IB, et al. EULAR E-congress 2020;LB0001.
  5. Cohen SB, et al. Arthritis Rheumatol. 2019; 71 (suppl 10):509.
  6. NICE (2022) Upadacitinib for treating active ankylosing spondylitis; Technology Appraisal Guidance; TA829. First published: 30th September 2022. Available at: https://www.nice.org.uk/guidance/TA829/
  7.  SMC Detailed Advice Document (SMC2480). Updacitinib (RINVOQ). First published: 7th November 2022. Available at: https://www.scottishmedicines.org.uk/medicines-advice/upadacitinib-rinvoq-as-full-smc2480/

UK-UPAD-230033. Date of preparation: March 2023

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 [email protected]