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ROME — The investigational oral Janus kinase 3 inhibitor tasocitinib, in combination with methotrexate, showed impressive dose-dependent efficacy for rheumatoid arthritis in a phase II study.
If the results of the ongoing phase III trials are positive, tasocitinib could become the first JAK3 inhibitor licensed for a nononcology indication, and the first new oral disease-modifying antirheumatic drug for RA in more than a decade.
In the phase II RA study presented by Dr. Yoshiya Tanaka, 136 patients with active disease (defined as six or more tender and swollen joints and a C-reactive protein level greater than 7 mg/dL) despite standard-dose methotrexate were randomized to add-on oral tasocitinib at 1, 3, 5, or 10 mg b.i.d. in double-blind fashion for 12 weeks.
Tasocitinib demonstrated a rapid, strong effect; significant benefit was seen within the first week, noted Dr. Tanaka, chair of internal medicine at the University of Occupational and Environmental Health in Kitakyushu, Japan.
In patients with a lower baseline DAS (Disease Activity Score) of 5.1 or less, the tasocitinib 1- and 3-mg b.i.d. arms showed a mean 1.5-point drop from baseline, whereas the 5- and 10-mg b.i.d. groups had decreases of 2.2 and 2.3 points, respectively, compared with a 0.7-point reduction with placebo.
In patients with a high baseline DAS (greater than 5.1), the mean reductions over 12 weeks of treatment with 1, 3, 5, and 10 mg b.i.d. were 2.3, 2.4, 2.8, and 3.4 points, respectively. But only the 10-mg b.i.d. dose was significantly better than placebo in achieving the key end points of DAS remission (a score lower than 2.6) and low disease activity state (a DAS of 3.2 or less). By week 12, roughly 70% of patients with a high baseline DAS and 90% of those with a lower baseline DAS had achieved LDAS on 10 mg b.i.d. of tasocitinib, compared with 10% and 20% of those on placebo.
Disclosures: The study was funded by Pfizer Inc. Dr. Tanaka disclosed that he serves as a consultant to Pfizer and is on the speakers bureaus for Mitsubishi Tanabe Pharma Corp. and several other Japanese pharmaceutical companies.
ROME — The investigational oral Janus kinase 3 inhibitor tasocitinib, in combination with methotrexate, showed impressive dose-dependent efficacy for rheumatoid arthritis in a phase II study.
If the results of the ongoing phase III trials are positive, tasocitinib could become the first JAK3 inhibitor licensed for a nononcology indication, and the first new oral disease-modifying antirheumatic drug for RA in more than a decade.
In the phase II RA study presented by Dr. Yoshiya Tanaka, 136 patients with active disease (defined as six or more tender and swollen joints and a C-reactive protein level greater than 7 mg/dL) despite standard-dose methotrexate were randomized to add-on oral tasocitinib at 1, 3, 5, or 10 mg b.i.d. in double-blind fashion for 12 weeks.
Tasocitinib demonstrated a rapid, strong effect; significant benefit was seen within the first week, noted Dr. Tanaka, chair of internal medicine at the University of Occupational and Environmental Health in Kitakyushu, Japan.
In patients with a lower baseline DAS (Disease Activity Score) of 5.1 or less, the tasocitinib 1- and 3-mg b.i.d. arms showed a mean 1.5-point drop from baseline, whereas the 5- and 10-mg b.i.d. groups had decreases of 2.2 and 2.3 points, respectively, compared with a 0.7-point reduction with placebo.
In patients with a high baseline DAS (greater than 5.1), the mean reductions over 12 weeks of treatment with 1, 3, 5, and 10 mg b.i.d. were 2.3, 2.4, 2.8, and 3.4 points, respectively. But only the 10-mg b.i.d. dose was significantly better than placebo in achieving the key end points of DAS remission (a score lower than 2.6) and low disease activity state (a DAS of 3.2 or less). By week 12, roughly 70% of patients with a high baseline DAS and 90% of those with a lower baseline DAS had achieved LDAS on 10 mg b.i.d. of tasocitinib, compared with 10% and 20% of those on placebo.
Disclosures: The study was funded by Pfizer Inc. Dr. Tanaka disclosed that he serves as a consultant to Pfizer and is on the speakers bureaus for Mitsubishi Tanabe Pharma Corp. and several other Japanese pharmaceutical companies.
ROME — The investigational oral Janus kinase 3 inhibitor tasocitinib, in combination with methotrexate, showed impressive dose-dependent efficacy for rheumatoid arthritis in a phase II study.
If the results of the ongoing phase III trials are positive, tasocitinib could become the first JAK3 inhibitor licensed for a nononcology indication, and the first new oral disease-modifying antirheumatic drug for RA in more than a decade.
In the phase II RA study presented by Dr. Yoshiya Tanaka, 136 patients with active disease (defined as six or more tender and swollen joints and a C-reactive protein level greater than 7 mg/dL) despite standard-dose methotrexate were randomized to add-on oral tasocitinib at 1, 3, 5, or 10 mg b.i.d. in double-blind fashion for 12 weeks.
Tasocitinib demonstrated a rapid, strong effect; significant benefit was seen within the first week, noted Dr. Tanaka, chair of internal medicine at the University of Occupational and Environmental Health in Kitakyushu, Japan.
In patients with a lower baseline DAS (Disease Activity Score) of 5.1 or less, the tasocitinib 1- and 3-mg b.i.d. arms showed a mean 1.5-point drop from baseline, whereas the 5- and 10-mg b.i.d. groups had decreases of 2.2 and 2.3 points, respectively, compared with a 0.7-point reduction with placebo.
In patients with a high baseline DAS (greater than 5.1), the mean reductions over 12 weeks of treatment with 1, 3, 5, and 10 mg b.i.d. were 2.3, 2.4, 2.8, and 3.4 points, respectively. But only the 10-mg b.i.d. dose was significantly better than placebo in achieving the key end points of DAS remission (a score lower than 2.6) and low disease activity state (a DAS of 3.2 or less). By week 12, roughly 70% of patients with a high baseline DAS and 90% of those with a lower baseline DAS had achieved LDAS on 10 mg b.i.d. of tasocitinib, compared with 10% and 20% of those on placebo.
Disclosures: The study was funded by Pfizer Inc. Dr. Tanaka disclosed that he serves as a consultant to Pfizer and is on the speakers bureaus for Mitsubishi Tanabe Pharma Corp. and several other Japanese pharmaceutical companies.