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PSORIATIC ARTHRITIS

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

 

Improvement in signs and symptoms as measured by ACR20 from as early as
Week 2 and maintained to Week 56, with significantly greater improvement in ACR20 vs placebo at Week 12 and non-inferiority vs adalimumab in ACR20 response at
Week 12.*1,3,4

Significantly more patients treated with RINVOQ achieved PASI 75 at Week 16 vs placebo.*

Significantly more patients achieved resolution of enthesitis and minimal disease activity at Week 24 vs placebo.*1,3,5

The safety profile of RINVOQ in PsA was consistent with previously reported results in rheumatoid arthritis and no new significant safety signals were
identified.1,3-8

*Data from SELECT-PsA 1 in adult non-bDMARD-IR patients with active PsA. Primary endpoint of SELECT-PsA 1, ACR20 response with RINVOQ vs placebo at Week 12, was met (71% vs 36%; p<0.001). PASI 75 for RINVOQ vs placebo at Week 16 was a multiplicity adjusted key secondary endpoint (63% vs 21%; p≤0.001). Minimal disease activity and resolution of enthesitis for RINVOQ vs placebo at Week 24 were multiplicity adjusted key secondary endpoints (36.6% vs 12.3%; p<0.001 and 53.7% vs 32.4%; p<0.001 respectively)

NICE Publishes Positive Technology Appraisal Guidance (TAG) for RINVOQ for treating active psoriatic arthritis in adults2

RINVOQ, alone or with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults whose disease has not responded well enough to DMARDs or who cannot tolerate them. 

It is recommended only if they have peripheral arthritis with 3 or more tender joints and 3 or more swollen joints and: 

• they have had 2 conventional DMARDs and at least 1 biological DMARD or 

• TNF-alpha inhibitors are contraindicated but would otherwise be considered. 

RINVOQ is recommended only if AbbVie provides it according to the commercial arrangement.


RINVOQ is accepted for use within NHS Scotland in patients with active Psoriatic arthritis 9

Indication under review: for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Upadacitinib may be used as monotherapy or in combination with methotrexate.

SMC restriction:

  • for use in patients with psoriatic arthritis whose disease has not responded adequately to at least two conventional DMARDs (cDMARDs), given either alone or in combination.

Upadacitinib offers an additional treatment choice in the therapeutic class of Janus Kinase (JAK) inhibitors in this setting. 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.

ACR20 = Improvement of at least 20% in the American College of Rheumatology core criteria; AS = Ankylosing Spondylitis; DMARDs = Disease-Modifying Antirheumatic Drugs; JAK = Janus Kinase; MTX = Methotrexate; NICE = National Institute for Health and Care Excellence; PASI 75 = Psoriasis Area and Severity Index 75% improvement; PsA = Psoriatic Arthritis; RA = Rheumatoid Arthritis; TAG = Technology Appraisal Guidance; TNF = Tumour Necrosis Factor.

References

  1. RINVOQ SmPC.
  2. NICE (2022) Upadacitinib for treating active psoriatic arthritis after inadequate response to DMARDs; Technology Appraisal Guidance; TA768. First published: 2nd February 2022. Available at: https://www.nice.org.uk/guidance/ta768 
  3. McInnes IB, et al. N Engl J Med 2021;384;1227-39.
  4. McInnes IB, et al. RMD Open 2021;7:e001838.
  5. Nash P, et al. Arthritis Rheumatol 2020; 72(suppl. 10):POS1035.
  6. van der Heijde D, et al. Lancet 2019;394:2108-2117.
  7. Deodhar A, et al. Arthritis Rheumatol 2020;72(suppl. 10):2023.
  8. Cohen SB, et al. EULAR E-Congress 2021;POS0220. 
  9. SMC Detailed Advice Document (SMC2361). Upadacitinib (RINVOQ). First published: 9th April 2022. Available at: https://www.scottishmedicines.org.uk/medicines-advice/upadacitinib-rinvoq-abb-smc2361/

UK-UPAD-230036. 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]