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Long Term Treatment for Severe Alopecia Areata with Oral Tofacitinib Citrate

Results from Cleveland Clinic's retrospective study indicate tofacitinib to be a safe and viable treatment option for patients with severe alopecia areata.

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Long Term Treatment for Severe Alopecia Areata with Oral Tofacitinib Citrate

  1. 1. Long-Term Treatment for Severe Alopecia Areata with Oral Tofacitinib Citrate Melissa Piliang, MD, FAAD Dermatology and Pathology Cleveland Clinic Allergan Incyte Conflict of interest Concert Samumed Allergan P&G Co-authors Wilma Bergfeld, MD Sara Hogan, MD
  2. 2. What’s New in Alopecia Areata Killing two birds with one stone Images obtained via Google, in public domain 25 year old man Alopecia areata since childhood Alopecia universalis for 7 years Psoriasis The case that stirred an interest in Jak I
  3. 3. JAK-Inhibitors Experience with JAK inhibitors for Alopecia Areata
  4. 4. OralTofactinib + AA: Cleveland Clinic Experience 2015-2018 • Retrospective, open-label • 20 patients • Mostly female (90%) • More likely to have: - Thyroid disease (65%) - Atopy (40%) - Many had autoimmune comorbitities • RA, psoriasis
  5. 5. OralTofactinib + AA: Cleveland Clinic Experience 2015-2018 • Severe disease: - Alopecia universalis - 70% - Alopecia totalis - 20% - Mean baseline SALT score - 88% • Average length of current episode of alopecia was 2.4 years
  6. 6. Doses ranged from 10-30 mg daily (most: 20 mg daily, divided dosing) 2017 analysis Overall, majority of patients experienced some form of regrowth 47% had regrowth by 12 months • Regrowth independent of • age • disease severity • disease duration • minimal side effect JAMA Dermatol, 2017 Jun 153(6): 600-602 Oral Tofactinib + AA: Cleveland Clinic Experience 2015-2016
  7. 7. Long Term Use of Tofactinib for AA Cleveland Clinic 2018 analysis Baseline moderate to severe AA (n=20) • Doses 10-30 mg daily • 13/20 patients taking tofacitinib for over 12 months • 30% with disease duration >20 years • 12% with nail involvement • 14/20 (70%) experienced hair regrowth by month 3 • 94% had regrowth by month 9 and 12 • SALT scores at month 3, 9, 12 months significantly lower than baseline • 11/12 of patients on Tofa >12 months still with regrowth • 3/12 (25%) with nail involvement had improvement • Also noted by month 3
  8. 8. CC: Alopecia Universalis HPI: 56 year old woman • 23 year history of alopecia universalis • Last notable hair growth was 19 years ago • Previous Treatments • Topical and intralesional corticosteroids • Pimecrolimus • Anthralin • Diphenylcyclopropenone • Methotrexate • Numerous nutritional supplements
  9. 9. Past Medical History: • Hashimoto’s thyroiditis on levothyroxine • Hyperlipidemia • Iron deficiency anemia
  10. 10. Physical Exam • Complete loss of scalp hair, eyelashes, eyebrows, body hair - SALT score of 100 • Pitting and trachonychia of all fingernails and toenails
  11. 11. Patient Course Started medication 5 mg BID Nov 2015 First hair growth 10 mg BID Jan 2016 SALT 22 May 2016 Complete regrowth April 2017 Regrowth maintained November 2018 April 2016 Herpes zoster May 2018 Influenza A SALT 100
  12. 12. Labs CBC with differential Peripheral eosinophilia (0.54) May 2017: resolved (0.37) December 2017: remains within normal limits (0.07) CMP within normal limits Lipid panel Initiation, hypercholesterolemia: (Cholesterol 217, Triglyceride 147, LDL 143) August 2016: hypertriglyceridemia (Cholesterol 250, Triglyceride 288, LDL 153) September 2016: started on atorvastatin September 2017: improved (Cholesterol 151, Triglyceride 178, LDL 68)
  13. 13. Patient #3 Baseline Month 16 Month 22 Month 30
  14. 14. Patient #9 Baseline Month 9 Month 12 Month 20
  15. 15. Patient #14 Baseline Month 3 Month 9 Month 24
  16. 16. Moderate Response Pre Post Dose: 5 mg BID Duration of therapy: 3.5 mos Age: 44 Duration of disease: 34 yrs
  17. 17. Mild Response Cose: 10 mg BID (20 mg) – has been as high as 15 mg BID Duration of therapy: 20 mo Age: 53 Duration of disease: 10 yrs Pre 18 Months10 Months
  18. 18. Minimal Response Dose: 10 mg BID Duration of therapy: 7 mo Age: 61 Duration of disease: 5 yrs Pre Post
  19. 19. No response Dose: 10 mg BID Duration of therapy: 7 mos Age: 55 Duration of disease: 7 yrs Pre Post
  20. 20. Current dose: 5 mg BID Duration of therapy: 6 mos Age: 53 Duration of disease: 30 yrs Excellent response No response Pre Month 6Month 5
  21. 21. What Happened? Month 5 Month 6 1. She lost coverage -> off Jak I for several weeks 2. Vit D was low 3. She was hypothyroid -> levothyroxine dose change
  22. 22. Patien t # Se x Age at treatment initiation Disease duration (years since diagnosis of AA) Time since last hair growth (years) Months until first signs of hair growth Duration of therapy (months) Holding dose (mg/day, split twice daily) SALT score at treatment initiation SALT score at final data collection Percent regrowth at time of last appointme nt 1 F 50s 25 1 3 22 20 100 30.8 69% 2 F 40s 19 4 3 15 20 78.3 32.2 59% 3 F 20s 16 3 17 15 100 50.6 49% 4 F 50s 26 4 7 28 15 100 44.8 50% 5 F 30s 13 1 0 0.5 10 95 44 50% 6 F 50s 16 2 10 26 20 100 95 5% 7 F 60s 7 1 3 7 20 100 95 5% 8 F 40s 36 3 3 3 10 79.3 44.2 40% 9 F 50s 15 1 12 20 76 3 96% 10 F 30s 9 3 4 15 10 100 98 2% 11 F 50s 9 7 8 24 20 100 20 80% 12 F 50s 31 1 3 6 10 100 1 99% 13 F 50s 1 6 20 10 95 0 100% 14 F 30s 7 1 1 12 20 50 0 100% 15 F 50s 11 1 2 25 25 71.6 38 47% 16 M 20s 5 2 3 4 10 100 100 0% “scant” 17 M 50s 3 2 2 12 20 100 50 50% 18 F 50s 16 6 2 5 10 90 47.2 48% 19 F 40s 17 8 13 10 50 0 100% 20 F 60s 44 1 3 4 10 100 100 10%
  23. 23. • 20 yo • Psoriasis and PsA
  24. 24. 1 month 5 mg bid 5 month 10 mg bid 7 month 10 mg bid
  25. 25. 10 months 15 mg bid Psoriasis improved Psoriatic arthritis persisted
  26. 26. • 15 months • 15 mg bid • PsO/PsA flared • No change or disruption in dose • No obvious reason
  27. 27. Durability with Long-Term Tofacitinib for AA • 6 patients experienced medication interruption • Adverse effect, illness, lapse in insurance coverage • 4/6 (66%) with medication interruption experienced shedding • Noted within 4 weeks • Resuming Tofacitinib after interruption had stabilization of shedding within 1-2 months • 2/20 discontinued due to adverse reactions
  28. 28. Tolerability with Long-Term Tofacitinib for AA • LFT elevation (2/20) 10% • Resolved with dose adjustment in 1, the other had to stop tofa • Hypercholesterolemia (3/20) 15% • Noted by month 4 of treatment • Slower to respond with dose adjustment • Other: • Lower Extremity Edema (1/20) 5%: medication discontinued • Palpitations (1/20) 5%: found to be hyperthyroid • Leukopenia (1/20) 5%: transient • Herpes reactivation (1/20) 5% Safe but close monitoring (every 3-4 months) important
  29. 29. Summary Tofacitinib Long Term Data • Results: - 75% achieved some regrowth - 60% - SALT50 - 25% - SALT90 (essentially fully regrowth) - 30-40% - insufficient or no response • Poor responders - Increase to 15-20 mg daily • Less likely to respond: - Longer duration of episode (>10 years) • Durability – 2 months post discontinuation – shedding
  30. 30. Take Home Points • This is a very exciting time for alopecia areata! The era of biologic treatment of AA is just beginning - Future • More options- precision targeted therapy • Better • Safer • More affordable (hopefully) Support National Alopecia Areata Foundation (NAAF) Thank you!

Results from Cleveland Clinic's retrospective study indicate tofacitinib to be a safe and viable treatment option for patients with severe alopecia areata.

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