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Could a New Oral Option for AS Meet the Needs of TNF-IRs?
Dr. Shelly Dunne
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June 9 2016 12:23 AM ET — via RheumReports 
There remains an unmet need in treating AS since we have fewer treatment options compared with RA and PsA. We all feel the frustration of dealing with an AS patient who is a true TNF inadequate responder and they do exist!
Today Dr Desiree van der Heijde presented an abstract entitled "Tofacitinib in Patients with Ankylosing Spondylitis: A Phase 2 ,16 week, randomized, placebo controlled dose-ranging study."
Tofacitinib is an oral JAK inhibitor that has been proven to be an efficacious and safe treatment for RA. It is particularly attractive because it is oral.
How about AS? This trial looked at 208 patients randomized 1:1:1:1 to placebo or tofacitinib 2, 5 or 10 mg bid. The primary endpoint was ASAS 20 plus the usual secondary endpoints including SPARCC score of SI joints and spine. Safety endpoints included adverse events and lab outcomes.
Results showed a typical AS cohort matched between the groups with mean age of 41 years, 81% were B27-positive, the mean BASDAI score was 6.7 and the mean disease duration was 6.3 years.
Tofacitinib 5 and 10 mg doses showed greater efficacy clinically and radiographically than placebo. There were no safety issues reported. There were two cases of zoster and no TB, malignancy, GI perforation or death. Changes in lab parameters were similar to those seen in other tofacitnib studies, and all returned to normal by 16 weeks.
It will be interesting to see what happens with this potential new option in AS, especially given that it is not approved for treatment of RA in the EU. And will the 5 mg dose be the approved dose as with RA?
A little tip I learned today from an esteemed colleague who will not be named is that grapefruit juice taken with tofacitinib will cause a drug interaction that effectively increases the dose for the patient. Use that tidbit of information as you see fit and stay tuned for more on tofacitinib in AS from EULAR 2016.
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About the Author
Dr. Shelly Dunne
Dr. Shelley Dunne is a graduate of Memorial University of Newfoundland School of Medicine. She completed her training in Internal Medicine and a fellowship in Rheumatology at the University of Toronto. She has been in private practice since 1998 and is currently a consulting rheumatologist at the Toronto East General Hospital.
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