Apremilast- Plaque Psoriasis and Psoriatic Arthritis (PsA)

Apremilast is a small molecule inhibitor of PDE4, approved by the Food and Drug Administration in 2014, and now available in India for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis. Its use in these patient populations has been assessed in two phase III clinical trial programs (ESTEEM in plaque psoriasis and PALACE I, II, and III in psoriatic arthritis).

Dosing

Available in tablet form, and recommended doses are 30 mg twice daily following an up-titration at a rate of 10 mg daily over 6 days.

Side effects

Common, usually mild to moderate adverse effects associated with apremilast include headache, back pain, nausea, diarrhea, fatigue, nasopharyngitis, and upper respiratory tract infections.
Other side effects of apremilast include depression (worsening depression, suicidal thoughts, and other mood changes) and weight loss. Reports from clinical studies indicated a 5% to 10% decrease in body weight in 10% of patients taking apremilast (compared with 3.3% of patients taking placebo).

Ixekizumab- Plaque Psoriasis and PsA

Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. It is available in many countries (not in India) for use in patients with plaque psoriasis and PsA.

Clinical Trials

In a randomized trial involving 417 patients with active PsA, most of whom had previously received a conventional nonbiologic disease-modifying antirheumatic drugs (DMARD), ixekizumab was more likely than placebo to achieve an ACR20 response at week 24 (62% and 58% vs. 30%) and achieved results comparable to adalimumab (40 mg every 2 weeks by subcutaneous injection). Ixekizumab reduced radiographic progression compared with placebo and improved psoriatic skin disease.

In another randomized trial involving 363 patients with active PsA who were either refractory, had loss of efficacy, or were intolerant to a TNF inhibitor, ixekizumab was more likely than placebo to achieve an ACR20 response at week 24 (48% and 53% vs. 20%).

Dosing

Subcutaneous: 160 mg once, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, and then 80 mg every 4 weeks.

Side Effects

Common side effects include hypersensitivity reactions and increased risk of infections. Of concern is the risk of inflammatory bowel disease, or its exacerbation.