Nine biologics are approved for rheumatoid arthritis (RA),
along with an oral kinase inhibitor (Pfizer/Takeda’s Xeljanz). New agents face
challenges in gaining uptake given rheumatologists’ long-standing familiarity
with the safety and efficacy profiles of the TNF-a inhibitors, the first
of which was approved in 1998, and, increasingly, of rituximab (Biogen
Idec/Roche/Chugai/Zenyaku Kogyo’s Rituxan, Roche’s MabThera) and abatacept
(Bristol-Myers Squibb/Ono Pharmaceutical’s Orencia), each of which was approved
for RA in 2006. To help drug developers negotiate the formidable barriers to
uptake in this market, we identify attributes with the greatest power to sway
rheumatologists’ prescribing decisions and gaps in efficacy and safety
achievements of select current and emerging therapies.
Attributes included in conjoint analysis based assessment of oral target product profiles for RA:
- % of methotrexate-refractory patients achieving an ACR 20 response at six months (adjusted to placebo + methotrexate).
- % of methotrexate-refractory patients achieving an ACR 50 response at six months (adjusted to placebo + methotrexate).
- Mean change (from baseline) in modified TSS score in methotrexate-refractory patients at one year.
- % of methotrexate-refractory patients achieving clinical remission (DAS28 < 2.6) at six months.
- Rate of serious infections per 100 patient-years (placebo-adjusted).
- Drug formulation.
Attributes included in assessment of U.S. payers’ receptivity to new oral therapies for RA:
- Effect on signs and symptoms of RA (ACR 50 response rate).
- Effect on progression of structural damage.
- Effect on remission (DAS28 < 2.6).
- Associated risk of serious infections.
Physicians surveyed: 60 U.S. and 34 European rheumatologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Adalimumab (AbbVie/Eisai’s Humira)
- Tofacitinib (Pfizer/Takeda’s Xeljanz)
- IV tocilizumab (Roche/Chugai’s RoActemra/Actemra)
- Abatacept (Bristol-Myers Squibb/Ono Pharmaceutical’s Orencia)
- Rituximab (Biogen Idec/Roche/Chugai/Zenyaku Kogyo’s Rituxan, Roche’s MabThera)
- Fostamatinib disodium (Rigel)
- Baricitinib (Eli Lilly/Incyte)
- SC tocilizumab (Roche/Chugai’s RoActemra/Actemra)
- Sirukumab (Janssen/GlaxoSmithKline)
- Secukinumab (Novartis)