Stelara vs. Enbrel trial results

The results of the first head-to-head trial between two biologic agents for the treatment of moderate-to-severe psoriasis was published in the New England Journal of Medicine last week.

The results reveal the superior efficacy of Stelara (ustekinumab) over high dose Enbrel (etaneracept).

The patients were divided into three groups. One received Stelara 45 mg at week 0 and week 4. Another received Stelara 90 mg at week 0 and week 4. The third group received or Enbrel 50 mg twice a week for 12 weeks.

At 12 weeks, a good response was recorded among:

• 50% of the Enbrel 50 mg group
• 67% of the Stelara 45 mg group
• 75% of the Stelara 90 mg group

Furthermore the half of the Enbrel group who did not obtain a good response following 12 weeks did show a good response with two doses of Stelara 90.

Although the safety between the groups was comparable, the long term safety data of Selara is not as well as established as it is for Enbrel which was FDA approved for psoriasis in 2003.

A new era of research: Biologics

Starting in 1998, The Psoriasis Treatment Center of Central New Jersey participated in clinical trials with Amevive (alefacept; Astellas Pharma). Over 50 patients who had not attained a prolonged remission with phototherapy participated in these trials. On January 31, 2003, Amevive became the first biologic agent to be FDA approved for the treatment of moderate-to-severe psoriasis.

Subsequently, The Psoriasis Treatment Center of Central New Jersey participated in clinical trials with other biologic agents:

• Enbrel (etanercept; Amgen-Wyeth/Pfizer) starting in 1999
• Raptiva (efalizumab; Genentech) in 2000
• Stelara (ustekinumab; Centocor Ortho Biotech) in 2005
• Humira (adalimumab; Abbott Labs) in 2006
• ABT-874 (Abbott Labs) in 2007

Our mission has been to offer clinical trials to people with psoriasis who have previously failed already FDA-approved therapies.

A Breakthrough

Through 1980 and beyond psoriasis was thought be a primary hyperproliferation of the epidermal cells. Normal epidermis takes 28 days to grow; in psoriasis the epidermis grows in 4 days. Consequently the skin does not have time to properly mature; it takes on psoriasis's characteristic scaly, red, rough appearance.

In 1979 at the University of Pittsburgh School of Medicine, a patient with psoriasis unfortunately also had renal failure (unrelated to psoriasis), requiring a kidney transplant. Following transplantation the patient was prescribed cyclosporine, a potent anti-inflammatory agent, to prevent rejection. Unbelievably, the patient's psoriasis went away. This was the beginning of a new understanding of psoriasis. The understanding of the pathogenisis of psoriasis had changed from a primary hyperproliferative process of the epidermis to an immunologically-mediated disease.

In 1992, The Psoriasis Treatment Center of Central New Jersey was fortunate enough to offer its patients the opportunity to participate in a clinical trial with cyclosporine. Soon thereafter we participated in a clinical trial of a novel biologic agent, DAB-IL 2, which selectively destroyed activated T cells known to contribute to psoriasis. DAB-IL-2 completely cleared some patients with widespread psoriasis however some patients had side effects. Our findings were published in the Journal of the American Academy of Dermatology (Volume 38, Issue 6, p. 938, June 1998) in a paper titled "Administration of DAB IL-2 to patients with recalcitrant psoriasis."

Ultimately, the risk-benefit ratio of DAB-IL2 was not good enough. However, we were now on the way to try newer, better, and safer biologic agents.

The early years (1985-1990)

In the mid- and late 80s, the Psoriasis Treatment Center saw more and more patients with moderate-to severe psoriasis.

The addition of a new drug, etretinate (first marketed as Tegison by Hoffman LaRoche), a retinoid somewhat like accutane, enhanced the benefit of phototherapy. Some said it had a synergistic effect.

Tegison would help normalize epidermal growth. Normal epidermis takes 28 to grow; in psoriasis it grows in about 4 days, and does not mature normally. Tegison decreased the scale on the surface of the skin and thereby allowed ultraviolet light to penetrate better.

With Tegison and PUVA the treatment called Re-PUVA was coined. The Psoriasis Treatment Center was at the forefront of this new combination therapy which decreased the number of phototherapy treatments necessary to obtain clearing.

During this era we also added a hand-foot UV light unit (PUVA) so that patients who had psoriasis on their palms and soles did not have to expose their entire body to light.

Having treated quite a few patients with psoriasis over the previous 7 years, I started attending all national and some international psoriasis symposiums. I realized I was asking the same questions as, and treating similarly to, the key opinion leaders of the time, including Drs. H. H. Roenig, Nicholas J. Lowe, and Alan Mentor. This inspired me to do more.

The first day of practice

In 1985 the state of the art for psoriasis treatment revolved around the "Rotational Therapy" concept designed by Dr. Gerald Weinstein at UC-Davis.

By changing treatments every so often, one could decrease the cumulative toxicity of each therapy. For example, after one year of methotrexate, switch to PUVA. Super-potent topical therapy did not exist in 1985, so a lot of Lidex (fluocinonide) ointment was used for localized psoriasis.

Broad band UVB was a useful therapeutic tool, however I quickly learned that patients requiring three treatments per week required accessible appointments, so we provided phototherapy appointments from 6 AM - 7 PM and Saturdays at the Psoriasis Treatment Center of Central NJ, so people did not have to miss work.

PUVA was also helpful for patients with more extensive disease.

The Psoriasis Treatment Center of Central New Jersey also offered psoriasis day care treatment, whereby patients with the most severe forms could receive Goeckerman therapy as an outpatient. We provided tar baths, tar applications, scalp debridements, anthralin application, and increasing doses of UVB, under the caring, watchful eyes of our trusted phototherapists Kim Raynor and Crystal Snyder who I am proud to say continue to provide outstanding psoriasis care at our Center.

So for severe psoriasis in 1985, we had phototherapy (UVB and PUVA) and methotrexate or topical therapy -- that was it.

And so it begins...

Greetings and Happy New Year, Happy New Decade

Today, Friday, January 1, 2010, I begin my blog as The Psoriasis Doctor, which is how I see myself. It all started in 1982 when I was fortunate enough to start my dermatology residency program at Columbia-Presbyterian Medical Center in NYC. 

During the three year residency program I spent six months taking care of hospitalized psoriasis center patients.They were receiving one month of Goeckerman therapy, which included daily phototherapy, applications of crude coal tar, tar baths, and moisturization. Under the tutalage of Chairman Dr. Leonard Harber, and the many great professors I had which included Drs. Silvers, Walther, Poh, Grossman, Schneiderman, Hutt, Edelson, Sanders, and many others.

I completed my derm residency on June 28, 1985 and that afternoon put up my shingle on 59 One Mile Road Extension, East Windsor, New Jersey as Jerry Bagel MD, Dermatology and Dermatology Surgery, and  Psoriasis Treatment Center of Central New Jersey.