Mixed tale for Pfizer psoriasis drug
pharmafile | October 11, 2013 | News story | Sales and Marketing | Enbrel, Pfizer, psoriasis, tofacitinib
Pfizer has seen its novel, oral Janus kinase (JAK) inhibitor tofacitinib turn in a mixed showing in late-stage trials in psoriasis.
Top-line results from two Phase III clinical studies in adults with moderate-to-severe chronic plaque psoriasis showed that, while the new drug is effective, it is not better than Pfizer’s existing Enbrel (etanercept) – an anti-tumour necrosis factor (TNF) therapy and current standard of care – at all doses.
In the 12-week OPT Compare study, 10mg of tofacitinib twice-daily met the primary endpoint of non-inferiority to high-dose Enbrel (50mg twice a week) – but the 5mg dose did not.
However, in the 56-week OPT Retreatment study, which looked at the efficacy and safety of withdrawal and retreatment with tofacitinib 5mg and 10 mg twice-daily compared to placebo, tofacitinib met its primary efficacy endpoints at both doses.
It demonstrated that more patients continuing tofacitinib treatment maintained their response during the treatment withdrawal phase compared to those who switched to placebo.
It is not unusual for patients with psoriasis to stop and restart therapy, which means this finding may have some relevance for doctors: and Pfizer says that, among patients who lost an adequate response, many recaptured it upon retreatment with tofacitinib.
No new safety signals were picked up in these studies, and results from three more are expected before June next year: taken together, this trial package will form the basis of regulatory submissions in psoriasis.
“The OPT Compare and OPT Retreatment studies provide information that is consistent with our expectations based on the Phase II data in psoriasis,” said Steven Romano, head of the Medicines Development Group for Pfizer Specialty Care.
“We look forward to the results of our remaining Phase III trials in order to fully evaluate tofacitinib in psoriasis and how it may fit into clinical practice for patients and physicians,” he added.
Other new treatments are snapping at Pfizer’s heels: last month one of Novartis’ investigational drugs beat Enbrel in a head-to-head psoriasis study, with subcutaneous secukinumab (AIN457) demonstrating superiority when it came to clearing skin.
Novartis believes it could provide a new mechanism of action to treat immune-mediated diseases, selectively binding to IL-17A, a pro-inflammatory cytokine – which is important in driving the body’s autoimmune response and is found in high concentration in skin affected by psoriasis – and neutralising its effect.
Tofacitinib is also being investigated by Pfizer in other areas and has not had a smooth ride: it was approved in the US as Xeljanz (tofacitinib citrate) to treat moderate-to-severe active rheumatoid arthritis (RA) last year – albeit with a Risk Evaluation and Mitigation Strategy (REMS) – but was rejected by European regulators in the same therapy area this year on the grounds that its benefits were weak and side effects were of concern.
Analysts had predicted Xeljanz could reach $2.5 billion in peak sales, but this figure may need to be revised following the EMA’s cold shoulder.
Adam Hill
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