FDA Adverse Data
Click on Adverse Effects of Biologics to see a compilation of data from the FDA on adverse events and deaths related to the use of various biologic agents.
The Safer Option
Phototherapy has a demonstrated history of safety and efficacy. The primary concern for most is whether phototherapy increases the risk of skin cancer. After many clinical studies and decades of use, there is no conclusive association between the two. In contrast, the fine print contained in the package labeling of the biologic drug products raises serious concerns. The potential associated risks are significant, including tuberculosis, listeriosis, liver failure, histoplasmosis, and other infectious diseases. Some risks are life threatening and difficult to resolve, such as lymphomas—cancers that attack the lymphatic system.
Better Clearance Rates
Phototherapy leads other treatments in both effectiveness and speed of clearance. Narrowband UVB and PUVA (Psoralen + UVA) are safe, work extremely well, and are twice as fast at clearing patients with moderate to severe psoriasis.
- PUVA (Psoralen + UVA): 90%1
- Daavlin Narrowband UVB: 82%6
- Remicade® (Infliximab): 80%5
- Humira® (Adalimumab): 62%4
- Enbrel® (Etanercept): 47%-49%3
Only Remicade® (Infliximab) approaches the clearance rates of phototherapy. Besides its high cost—nearly $20,000 per patient per year—Remicade has a lengthy list of side effects and typically takes several months of treatment to show results.
Faster Clearance Times
Phototherapy is more effective than competing biological drugs and it works nearly twice as fast. Of the biologics, only Enbrel® is approved for pediatric use in the treatment of psoriasis (Narrowband UVB is approved and has a long track record of safe pediatric use).
Median Time to Reach Clearance:
- PUVA (Psoralen+UVA): 4 weeks2
- Narrowband UVB: 5 weeks1
- Remicade® (Infliximab): 8 weeks5
- Humira® (Adalimumab): 8 weeks4
- Enbrel® (Etanercept): 8 weeks3
When used with topical drugs, phototherapy combination treatments are even more effective, with reports of up to a 93% clearance rate with a Narrowband UVB + Etretinate combination. The bottom line: Daavlin phototherapy works faster and better.
What is Phototherapy?
Phototherapy uses very specific bands of light to treat skin conditions such as psoriasis, vitiligo, and eczema in a safe, natural, effective, and painless way. How can phototherapy help you?
1 Palmer, et al. Photoadaptation during Narrowband Ultraviolet-B Therapy Is Independent of Skin Type: A Study of 352 Patients Journal of Investigative Dermatology (2006) 126, 1256–1263
2 Yones, et al. Randomized double-blind trial of the treatment of chronic plaque psoriasis: efficacy of psoralen-UV-A therapy vs narrowband UV-B therapy. Arch Dermatol. 2006 Jul;142(7):836-42.
3 ENBREL® Physician Package Insert. Available at: http://www.enbrel.com/pdf/enbrel_pi.pdf
4 HUMIRA® Prescribing Information. Available at: http://www.rxabbott.com/pdf/humira.pdf
5 REMICADE® Prescribing Information. Available at: http://www.remicade.com/remicade/assets/HCP_PPI.pdf
6 Suberythemogenic narrow-band UVB is markedly more effective than conventional UVB in treatment of psoriasis vulgaris, Walters, et al. Journal of the American Academy of Dermatology, Volume 40, Issue 6, June 1999, Pages 893-900