Opportunity Awaits Therapies Offering Improvements in Efficacy and Safety over Currently Available TNF-Alpha Inhibitors
The availability of tumor necrosis factor alpha (TNF-α) inhibitors as therapeutic options has revolutionized the treatment of psoriatic arthritis (PsA). The TNF-α inhibitors have set a high clinical standard (e.g., excellent efficacy in both peripheral and axial PsA, low risk of organ toxicity) that is challenging for emerging therapies to surpass. However, unmet needs exist for improvements in various efficacy, safety and tolerability, and delivery attributes. A number of therapies, including those that will offer improvements over the TNF-α inhibitors on delivery or safety, are in late-stage development for PsA; however, based on the current trial data for these agents, significant opportunity remains for new drugs that offer efficacy that surpasses that of the TNF-α inhibitors.
Attributes included in conjoint analysis based assessment of target product profiles for PsA:
- Effect on peripheral disease—ACR 20 response at 6 months (% of patients, placebo-adjusted).
- Effect on axial disease—ASAS 20 response at 6 months (% of patients, placebo-adjusted).
- Effect on skin—PASI 75 response at 6 months (% of patients, placebo-adjusted).
- Risk of liver toxicity (% of patients with alanine transaminase [ALT] levels >3x the upper level of normal [ULN], placebo-adjusted).
- Rate of serious infections (per 100 patient-years, placebo-adjusted).
- Delivery burden (drug formulation and dosing).
Attributes included in assessment of U.S. payers’ receptivity to new therapies for PsA:
- Effect on signs and symptoms of arthritis (ACR 20 response at 6 months).
- Effect on skin (PASI 75 response at 6 months).
- Rate of serious infections (per 100 patient-years).
- Formulation and dosing frequency.
Physicians surveyed: 60 U.S. and 30 European rheumatologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Etanercept (Amgen/Pfizer/Takeda Pharmaceutical’s Enbrel)
- Adalimumab (AbbVie/Eisai’s Humira)
- Infliximab (Janssen Biotech/Merck/Mitsubishi Tanabe Pharma’s Remicade)
- Ustekinumab (Janssen Biotech’s Stelara)
- Certolizumab pegol (UCB/Astellas Pharma’s Cimzia)
- Methotrexate (Dava Pharmaceuticals’ Rheumatrex, generics)
- Apremilast (Celgene’s Otezla)
- Tofacitinib (Pfizer/Takeda Pharmaceutical’s Xeljanz)
- Secukinumab (Novartis)
- Abatacept (Bristol-Myers Squibb/Ono Pharmaceutical’s Orencia)