2014Australian PrescriberOpen access

Experimental and Clinical Pharmacology:Janus kinase inhibitors in rheumatoid arthritis: Clinical applications

Jennifer Walker, Malcolm Smith

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Abstract

ORAL Solo trialA six month, double-blind study enrolled 611 patients who had not had an adequate response to at least one non-biological or biological disease-modifying drug.Patients received placebo or tofacitinib 5 mg or 10 mg twice daily in addition to usual care.Antimalarial drugs, non-steroidal anti-inflammatory drugs and glucocorticoids (≤10 mg prednisone/day) were permitted but all other disease-modifying drugs were discontinued for the trial.A clinical benefit was demonstrated, but there was no significant increase in the number of patients entering remission according to disease activity score criteria.7 This suggested that while tofacitinib is effective as a monotherapy, additional disease-modifying therapy may be required. ORAL Step studyResponses among patients with more resistant disease have also been assessed.A six-month study enrolled 399 people who had not responded to at least one tumour necrosis factor inhibitor.Patients were randomised to placebo or tofacitinib (5 mg or 10 mg twice a day).After three months, patients who received placebo were transferred to tofacitinib.Once again, significant improvements were observed in ACR 20 response rates after three months and Janus kinase inhibitors in rheumatoid arthritis Clinical applications SUMMARYTofacitinib, an oral Janus kinase inhibitor, is an effective treatment for rheumatoid arthritis.Adverse effects are generally mild and include cytopenias and hyperlipidaemia.Opportunistic infections such as herpes zoster may occur with tofacitinib.

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ORAL Solo trialA six month, double-blind study enrolled 611 patients who had not had an adequate response to at least one non-biological or biological disease-modifying drug.Patients received placebo or tofacitinib 5 mg or 10 mg twice daily in addition to usual care.Antimalarial drugs, non-steroidal anti-inflammatory drugs and glucocorticoids (≤10 mg prednisone/day) were permitted but all other disease-modifying drugs were discontinued for the trial.A clinical benefit was demonstrated, but there was no significant increase in the number of patients entering remission according to disease activity score criteria.7 This suggested that while tofacitinib is effective as a monotherapy, additional disease-modifying therapy may be required. ORAL Step studyResponses among patients with more resistant disease have also been assessed.A six-month study enrolled 399 people who had not responded to at least one tumour necrosis factor inhibitor.Patients were randomised to placebo or tofacitinib (5 mg or 10 mg twice a day).After three months, patients who received placebo were transferred to tofacitinib.Once again, significant improvements were observed in ACR 20 response rates after three months and Janus kinase inhibitors in rheumatoid arthritis Clinical applications SUMMARYTofacitinib, an oral Janus kinase inhibitor, is an effective treatment for rheumatoid arthritis.Adverse effects are generally mild and include cytopenias and hyperlipidaemia.Opportunistic infections such as herpes zoster may occur with tofacitinib.

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Available abstract

ORAL Solo trialA six month, double-blind study enrolled 611 patients who had not had an adequate response to at least one non-biological or biological disease-modifying drug.Patients received placebo or tofacitinib 5 mg or 10 mg twice daily in addition to usual care.Antimalarial drugs, non-steroidal anti-inflammatory drugs and glucocorticoids (≤10 mg prednisone/day) were permitted but all other disease-modifying drugs were discontinued for the trial.A clinical benefit was demonstrated, but there was no significant increase in the number of patients entering remission according to disease activity score criteria.7 This suggested that while tofacitinib is effective as a monotherapy, additional disease-modifying therapy may be required. ORAL Step studyResponses among patients with more resistant disease have also been assessed.A six-month study enrolled 399 people who had not responded to at least one tumour necrosis factor inhibitor.Patients were randomised to placebo or tofacitinib (5 mg or 10 mg twice a day).After three months, patients who received placebo were transferred to tofacitinib.Once again, significant improvements were observed in ACR 20 response rates after three months and Janus kinase inhibitors in rheumatoid arthritis Clinical applications SUMMARYTofacitinib, an oral Janus kinase inhibitor, is an effective treatment for rheumatoid arthritis.Adverse effects are generally mild and include cytopenias and hyperlipidaemia.Opportunistic infections such as herpes zoster may occur with tofacitinib.

Key concepts: Tofacitinib, Janus kinase inhibitor, Janus kinase, Rheumatoid arthritis, Medicine, Pharmacology, Clinical pharmacology, Kinase

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