Table 1.
Clinical outcomes and tolerability with cyclosporine for cohort of patients with omalizumab-refractory chronic urticaria
| Patient #1 | Patient #2 | Patient #3 | Patient #4 | Patient #5 | |
|---|---|---|---|---|---|
| Age | 24 | 35 | 41 | 39 | 58 |
| Gender | Female | Male | Female | Male | Female |
| Comorbidities | None | Vitiligo, chronic rhinitis | Hypertension, headaches, chronic rhinitis | Asthma, chronic rhinitis, hyperthyroidism | Asthma, chronic rhinitis, thyroid cancer (s/p thyroidectomy), hypertension |
| BMI | 26 kg/m2 | 36 kg/m2 | 35 kg/m2 | 33 kg/m2 | 34 kg/m2 |
| Urticaria type | Chronic spontaneous urticaria | Chronic spontaneous urticaria | Chronic spontaneous urticaria | Chronic inducible urticaria | Chronic spontaneous urticaria |
| Urticaria Duration | 7 months | 12 months | 9 months | 18 months | 12 months |
| Pertinent laboratory studies | ANA, RF, and cryoglobulin negative. Normal TSH. Anti-TPO and Anti-thyroglobulin antibodies negative | ANA negative. Normal TSH | Normal TSH | ANA negative. Anti-TPO and Anti-thyroglobulin antibodies negative | ANA negative. Anti-thyroglobulin antibodies negative |
| Prior use of corticosteroids | Yes | No | Yes | No | Yes |
| Omalizumab Dose | 300 mg every 4 weeks | 300 mg every 4 weeks | 300 mg every 4 weeks | 300 mg every 4 weeks | 300 mg every 4 weeks |
| Omalizumab treatment duration | 20 weeks | 48 weeks | 12 weeks | 52 weeks | 12 weeks |
| Cyclosporine Dose (milligram per kilogram per day) | 3 | 1 | 1 | 1; dose later increased to 3 | 1.25; dose later increased to 3 |
| Cyclosporine dosage categorya | Low-Dose | Very Low-Dose | Very Low-Dose | Very Low-Dose (initially) low-dose was later used due to lack of clinical improvement | Very low-dose (initially) low-dose was later used during a recurrence when symptoms failed to respond to very low doses |
| Cyclosporine treatment duration | 16 weeks | 16 weeks | 30 weeks | 44 weeks | 24 weeks |
| Concomitant medicationsb | Cetirizine 20 mg twice daily, Ranitidine 150 mg twice daily | Fexofenadine 360 mg twice daily, Ranitidine 150 mg twice daily | Cetirizine 20 mg twice daily, Ranitidine 150 mg twice daily, Hydroxyzine 25 mg daily every evening, Montelukast 10 mg daily | Cetirizine 10 mg twice daily, Fexofenadine 180 mg daily, Hydroxyzine 25 mg daily every evening, Ranitidine 150 mg twice daily, Montelukast 10 mg daily | Cetirizine 20 mg twice daily, Ranitidine 150 mg twice daily, Montelukast 10 mg daily |
| Clinical Response to cyclosporinec | Complete response | Complete response | Complete response | Near-complete improvement of cholinergic urticaria, moderate improvement of pressure-induced urticaria | Complete response |
| Time to clinical improvement on cyclosporine therapy | 2 weeks | 1 week | 2 weeks | 24 weeks | 1 week |
| Relapse (if remission had occurred) | No | No | Yes | N/A | Yes |
| Adverse effects of cyclosporine | None | None | During second course of cyclosporine developed hypertension (did not prompt drug discontinuation) | Hypertension, hyperglycemia, hematuria, elevated uric acid (prompting cessation)d | During second course of cyclosporine developed elevated creatinine (peak 1.24 from baseline 1.00), prompting cessatione |
aCyclosporine dosage is categorized into 2 groups: (1) very low (< 2 mg/kg/d) and (2) low (2–3.99 mg/kg/d) dose
bSame doses were used during omalizumab and cyclosporine treatment
cPatient observation, which informed provider documentation, was used to characterize clinical response rates
dBlood pressure, blood glucose, serum uric acid, and hematuria normalized after cessation of cyclosporine
eSerum creatinine returned to baseline after cessation of cyclosporine