FDA approves Cosentyx for the treatment of ankylosing spondylitis and psoriatic arthritis

Analysis from UpdatesPlus-Spondyloarthropathy - Industry's source for market intelligence and monitoring

• We reported in November that the EMA had approved Cosentyx for the treatment of psoriatic arthritis and ankylosing spondylitis.  This coincided with impressive data reported at ACR
• In particular, for ankylosing spondylitis Cosentyx efficacy in MEASURE 2 (dosing with the approved sc induction regimen) was maintained for 52wks and was associated with long term prevention of radiographic progression in MEASURE 1.  An observation that the presenters differentiated from a lack of TNFi effect
  
• For psoriatic arthritis notable data included long term benefit including 104wk data from FUTURE 1 (iv induction) and 52wk data for FUTURE 2 (approved sc induction).  Cosentyx demonstrated efficacy in FUTURE 2 irrespective of TNF treatment history or MTX background, although 300mg produced an improved effect (vs 150mg) in TNF-IRs or those patients with skin involvement.  The involvement of IL-17 in enthesitis, and the importance of enthesitis in psoriatic arthritis were stand out messages at ACR and Cosentyx produced a considerable improvement in this measure
• The Cosentyx SPC was since updated.  Importantly Cosentyx is specifically approved with or without MTX for psoriatic arthritis in DMARD-IRs without specifying conventional or biologic DMARD.  This opens the way for possible first line biologic use.  300mg Cosentyx is indicated in TNF-IRs and those with moderate to severe plaque psoriasis, but 150mg is indicated in others.  This reflects FUTURE 2 and importantly could offer a  cost benefit for pre-TNFi use.  Of note the label included a considerable amount of data on enthesitis.  For ankylosing spondylitis, the indicated dose is 150mg for all with no guidance offered on line of treatment or MTX background.  Radiographic data were not included, possibly because 104wk data reporting progression were not available at the time of filing
• The FDA has now reportedly approved Cosentyx for the treatment of both ankylosing spondylitis and psoriatic arthritis.  Further detail are yet to be disclosed