The clinical effectiveness agency for England and Wales said in draft guidance Oct. 6 that it would not recommend golimumab to treat psoriatic arthritis, saying that it was less effective than another drug in the same class, and that it may in practice be costlier than its manufacturer says.

In August, the National Institute for Health and Clinical Excellence recommended three similar drugs for adults with psoriatic arthritis who have not responded well to standard disease-modifying anti-rheumatic therapies, such as methotrexate and sulfasalazine. All three – adalimumab, etanercept and infliximab – are TNF-inhibitors, human monoclonal antibodies that inhibit the binding of tumor necrosis factor to its receptors.

Treatment with etanercerpt (Enbrel, Wyeth Pharmaceuticals) costs £9,295 ($14,782.50) per year assuming a 50 mg once-weekly dose (52 doses per year) or 25 mg twice-weekly dose (104 doses per year). Treatment with adalimumab (Humira, Abbot Laboratories) costs £9,295 ($14,782.50) per year, assuming a 40-mg dose given every two weeks (26 doses per year). Treatment with infliximab (Remicade, Schering-Plough) for an adult weighing 75 kg costs £10,910 ($17,352.16) per year based on infusions repeated every 8 weeks (average of 6.5 doses per year), according to a statement on psoriatic arthritis treatment issued by NICE in August.

Golimumab (Simponi, Schering-Plough/Centocor), also a TNF-inhibitor, is administered via monthly self-injections of 50 mg (or 100 mg for people weighing at least 100 kg). Treatment costs an estimated £9,295 (14,782.50) per year, on par with etanercept and adalimumab, for a normal-weight person. The NICE reviewers said, however, they believed a "significant" portion of patients would be eligible for the higher dose, which is double the cost, making cost-effectiveness estimates for golimumab less favorable.

The NICE reviewers said they did consider the drug's monthly dosing as an advantage to patients, compared with the other TNF inhibitors. They also determined, based on the results of one Phase III manufacturer-sponsored randomized controlled trial of 405 patients, that golimumab 50 mg was effective compared with placebo (Arthritis Rheum. 2009;60:976-86). However, a mixed treatment comparison presented by the manufacturer showed that it was not as effective as etanercept for the same patient group.

The reviewers also noted some safety concerns about golimumab, including a lack of long-term safety data; some adverse events reported in the randomized controlled trial (though the trial was not powered to detect statistically significant differences in adverse effect outcomes); and concerns related to its 12-day half life. For example, they said, "the longer retreatment interval with golimumab may result in longer periods of discomfort because of waning efficacy before retreatment," and in the case of an adverse event, "it would take longer for the treatment effect to wear off."

NICE's guidance on golimumab is not yet final; the agency is accepting comments until Oct. 27.

10/06/10